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BACKGROUND: In this phase 2 randomised placebo-controlled clinical trial in patients with COVID-19, we hypothesised that blocking mineralocorticoid receptors using a combination of dexamethasone to suppress cortisol secretion and spironolactone is safe and may reduce illness severity. METHODS: Hospitalised patients with confirmed COVID-19 were randomly allocated to low dose oral spironolactone (50 mg day 1, then 25 mg once daily for 21 days) or standard of care in a 2:1 ratio. Both groups received dexamethasone 6 mg daily for 10 days. Group allocation was blinded to the patient and research team. Primary outcomes were time to recovery, defined as the number of days until patients achieved WHO Ordinal Scale (OS) category ≤ 3, and the effect of spironolactone on aldosterone, D-dimer, angiotensin II and Von Willebrand Factor (VWF). RESULTS: One hundred twenty patients with PCR confirmed COVID were recruited in Delhi from 01 February to 30 April 2021. 74 were randomly assigned to spironolactone and dexamethasone (SpiroDex), and 46 to dexamethasone alone (Dex). There was no significant difference in the time to recovery between SpiroDex and Dex groups (SpiroDex median 4.5 days, Dex median 5.5 days, p = 0.055). SpiroDex patients had significantly lower D-dimer levels on days 4 and 7 (day 7 mean D-dimer: SpiroDex 1.15 µg/mL, Dex 3.15 µg/mL, p = 0.0004) and aldosterone at day 7 (SpiroDex 6.8 ng/dL, Dex 14.52 ng/dL, p = 0.0075). There was no difference in VWF or angiotensin II levels between groups. For secondary outcomes, SpiroDex patients had a significantly greater number of oxygen free days and reached oxygen freedom sooner than the Dex group. Cough scores were no different during the acute illness, however the SpiroDex group had lower scores at day 28. There was no difference in corticosteroid levels between groups. There was no increase in adverse events in patients receiving SpiroDex. CONCLUSION: Low dose oral spironolactone in addition to dexamethasone was safe and reduced D-dimer and aldosterone. Time to recovery was not significantly reduced. Phase 3 randomised controlled trials with spironolactone and dexamethasone should be considered. TRIAL REGISTRATION: The trial was registered on the Clinical Trials Registry of India TRI: CTRI/2021/03/031721, reference: REF/2021/03/041472. Registered on 04/03/2021.
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COVID-19 , Humans , Spironolactone/adverse effects , SARS-CoV-2 , Aldosterone , Angiotensin II , von Willebrand Factor , COVID-19 Drug Treatment , Dexamethasone/adverse effects , Treatment Outcome , Randomized Controlled Trials as TopicABSTRACT
Background and Aims: Several studies have attempted to identify patients at risk of developing severe pain after caesarean section (CS) by utilizing preoperative experimental pain application and clinical tests. The three-item questionnaire and reported pain intensity on infiltration of local anesthetic (LA) on the back of patient just before administration of spinal anesthesia, are two simple tests previously shown to be promising. We aimed to study utility of these two tools in Indian patients undergoing CS and find their correlation with postoperative pain and analgesic consumption. Material and Methods: A total of 150 parturients undergoing elective CS were enrolled. Preoperatively patients were asked to rate their level of anxiety, anticipated postoperative pain and analgesic need after surgery (three-item questionnaire). The pain intensity reported by patient upon LA injection for spinal anesthesia were recorded. In the postoperative period, pain intensity at rest, evoked pain and need for rescue analgesics were recorded. The correlation between three item questionnaire and pain on LA infiltration to postoperative pain were evaluated. To see relationship between the predictor variables to outcome, a multiple regression analysis was performed. Results: The predictors variables and postoperative pain were found to have mild correlation (r = 0.124 to 0.239). The predictor variables were significantly correlated with postoperative pain at rest but their association was not significant to evoked pain intensity. Multiple regression analysis showed that change in the predictors explains only 7-8% variance in postoperative pain outcomes. Conclusion: The three -item questionnaire and pain intensity reported upon LA infiltration for spinal anesthesia have mild correlation to postoperative pain in Indian parturients undergoing CS. As these variables predicts only 8% variance in pain experienced after CS, further studies are required for accurate prediction and targeted treatment of post CS pain.
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Background and Aims: Post the second wave of COVID-19 in India, our institute became a dedicated center for managing COVID-19-associated mucormycosis (CAM), but there was a paucity of data regarding perioperative considerations in these patients. The objectives of present study was to describe the preoperative clinical profile, the perioperative complications and outcome of CAM patients undergoing urgent surgical debridement. Material and Methods: This prospective observational study was conducted on CAM patients presenting for surgical debridement from July to September 2021. During preoperative visits, evaluation of extent of disease, any side effects of ongoing medical management and post-COVID-19 systemic sequalae were done. The details of anaesthetic management of these patients including airway management, intraoperative haemodynamic complications and need for perioperative blood transfusion were noted. Results: One hundred twenty patients underwent surgical debridement; functional endoscopic sinus surgery (FESS) was carried out in 63% of patients, FESS with orbital exenteration in 17.5%, and maxillectomy in 12.5%. Diabetes mellitus was found in 70.8% and post-COVID new onset hyperglycemia in 29.1% of patients. Moderate-to-severe decline in post-COVID functional status (PCFS) scale was observed in 73.2% of patients, but with optimization, only 5.8% required ICU management. The concern during airway management was primarily difficulty in mask ventilation (17.5%). Intraoperatively, hemodynamic adverse events responded to conventional treatment for hypotension, judicious use of fluids and blood transfusion. Perioperatively, 10.8% of patients required blood transfusion and 4.2% of patients did not survive. Non-surviving patients were older, with a more aggressive involvement of CAM, and had comorbidities and a greater decline in functional capacity. Conclusion: A majority of patients reported a moderate-to-severe decline in PCFS that required a preoperative multisystem optimization and a tailored anesthetic approach for a successful perioperative outcome.
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Background and aims: The coronavirus disease-2019 (COVID-19) has significant positive and negative impacts on the professional life of intensive care unit (ICU) professionals. This study was conducted to evaluate compassion satisfaction (CS), burnout (BO), and secondary traumatic stress (STS) in ICU professionals and to study demographic and occupational variables related to them. Methods: This prospective observational study was undertaken on ICU professionals involved in direct care of critically ill COVID-19 patients. The online questionnaire consisting of demographic, work-related parameters, and professional quality of life scale version 5 (ProQOL 5) was sent to 1,080 ICU healthcare workers. The subgroups of ProQOL 5, CS, BO, and STS were calculated and compared across study parameters. Linear regression was performed to evaluate variables which were independently associated with ProQOL. Results: The response rate in the present study was 39.8%, and after evaluation, 320 responses were found eligible for final analysis. There was predominance of average levels of CS, BO, and STS. Female gender, contractual job, lesser work experience, greater workload, and COVID-19 infection in close acquittance of participants were factors observed to independently associated with increase in negative aspects of ProQOL (BO and STS). Further, increase in duty hours and COVID-19 infection in close social circle were observed to independently decrease positive aspects (CS). Conclusion: This study shows that despite majority of respondents reporting moderate levels BO and STS, CS is maintained during the COVID-19 crisis. The identification of risk factors is vital to support ICU professionals by targeted interventions. How to cite this article: Kerai S, Doda P, Saxena KN. Professional Quality of Life in Intensive Care Unit Professionals during COVID-19 Pandemic: A Prospective Observational Cross-sectional Study. Indian J Crit Care Med 2022;26(5):604-612.
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BACKGROUND: The use of high-flow nasal cannula (HFNC) in coronavirus disease-2019 (COVID-19) patients is debated due to its uncertain benefits and risks of aerosol dispersion. This retrospective study was aimed to assess the outcome of treatment with HFNC therapy in adult COVID-19 patients with acute hypoxemic respiratory failure (AHRF) admitted in intensive care units (ICU) and to assess the factors affecting outcome. MATERIAL AND METHODS: We retrieved electronic medical records of all COVID-19 patients who received HFNC for respiratory support after failure to maintain adequate oxygenation with conventional oxygen devices, between June 1 and August 31, 2020. The data retrieved were statistically analyzed. RESULTS: A total number of 558 COVID-19 patients were admitted to ICUs, out of which 139 patients were identified to be on HFNC and 85 met the inclusion criteria for the study. The success rate of 48.2% with HFNC was observed in these patients. The patients recorded to experience HFNC success were of young age and having higher baseline oxygen saturation compared to those who had its failure. The ROX indices post-initiation were observed to be significantly higher in the success group (p ≤0.001). Awake-prone positioning while receiving HFNC was followed by around more patients in the success group (p <0.001). On multivariate logistic regression analysis, baseline oxygen saturation, awake-prone positioning, and number of days on HFNC were found to be independently affected outcome with HFNC. CONCLUSION: Almost half of the cases of moderate-to-severe COVID-19 pneumonia can be managed successfully with HFNC, without the need of mechanical ventilation. HOW TO CITE THIS ARTICLE: Kerai S, Singh R, Saxena KN, Desai SD, Bhalotra AR. A Retrospective Study on Experience of High-flow Nasal Cannula Oxygen in Critically Ill COVID-19 Adult Patients Admitted to Intensive Care Unit. Indian J Crit Care Med 2022;26(1):62-66.
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BACKGROUND AND AIMS: With the rise of coronavirus disease-2019 (COVID-19) cases globally, the infection among frontline healthcare workers (HCWs) escalates many folds. There is, however, limited literature from low middle-income countries regarding risk factors for COVID-19 infection in HCWs. We conducted a case-control study to evaluate the risk factors of COVID-19 infection to HCWs. MATERIALS AND METHODS: This case-control study was conducted in a designated COVID-19 hospital. Eighty-one HCWs involved in direct care of COVID-19 patients, identified as cases, and 266 were recruited as controls. Telephonic interviews with participants were conducted, and information regarding demographic variables, chemoprophylaxis, exposure to infected patients, and adherence to infection prevention and control (IPC) measures was collected. RESULTS: We observed a statistically significant difference in the number of times training session for IPC measures attended by HCWs (p = 0.02), performance of aerosol-generating medical procedures (AGMPs) (p <0.001), practices of donning and doffing of personal protective equipment (PPE) (p <0.001), hand hygiene (p <0.001), and decontamination of highly touched surfaces (p <0.001). Logistic regression analysis revealed if the decontamination of highly touched surfaces is decreased by one unit, the odds of getting COVID-19 infection is multiplied by a factor of 0.41 and AGMPs decrease the risk of being a case by 0.76. CONCLUSION: This study highlighted that inadequate observation of IPC methods increases the risk of COVID-19 infection to frontline HCWs, whereas performance of AGMPs does not enhance the risk. In this study, HCWs undertaking an AGMP, because of concern of acquiring infection, were more diligent during procedures and hence had lesser infection. HOW TO CITE THIS ARTICLE: Kerai S, Singh R, Saxena KN, Desai SD. Assessment of Risk Factors for Coronavirus Disease-2019 in Healthcare Workers: A Case-Control Study. Indian J Crit Care Med 2022;26(1):76-84.
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BACKGROUND: Coronavirus disease-2019 (COVID-19) continues to pose serious challenges to healthcare systems globally with the disease progressing over time in crest-trough pattern of waves. We compared the patient characteristics and outcomes of critically ill patients admitted during the first and second waves of COVID-19 pandemic. MATERIALS AND METHODS: We did a retrospective analysis of medical records of critically ill patients admitted to intensive care unit (ICU) at the peak period of both waves. The data on demographics, symptoms, treatment received, and outcomes of patients were recorded. RESULTS: Compared to first wave, significantly more females, younger age group, and those without underlying comorbidities required ICU admission during the second wave. The treatments received during both periods were similar except for preferential use of methylprednisolone over dexamethasone and proclivity of bilevel positive airway pressure (BiPAP) ventilation over high-flow nasal cannula (HFNC). There was no significant difference in the duration of ICU stay and mortality of patients. During the first wave, the factors associated with nonsurvival of patients were advanced age, comorbidities, severe disease, and a lesser number of days on HFNC. All these factors along with higher Sequential Organ Failure Assessment (SOFA) score were observed to be linked with patient nonsurvival during the second wave. CONCLUSION: In India, the second wave of COVID-19 significantly influenced ICU demographics with a predominance of females and young adults requiring critical care. During both time periods, patients received similar treatment except for the propensity to use methylprednisolone and BiPAP as opposed to dexamethasone and HFNC in second wave. No significant difference in ICU mortality was noted. HOW TO CITE THIS ARTICLE: Kerai S, Singh R, Dutta S, Mahajan A, Agarwal M. Comparison of Clinical Characteristics and Outcome of Critically Ill Patients Admitted to Tertiary Care Intensive Care Units in India during the Peak Months of First and Second Waves of COVID-19 Pandemic: A Retrospective Analysis. Indian J Crit Care Med 2021;25(12):1349-1356.
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High-flow nasal oxygen therapy warms and humidifies gases, allows better clearance of secretions, along with providing added benefits like preventing dehydration of airway surface, while decreasing atelectasis and thereby, offering comfort to the patient. While its effect on critically ill patients is still in its pioneering phase, there is lack of substantial evidence on the use of high-flow nasal cannula in cardiac patients with type I respiratory failure. We found it worthwhile to share our experience of its use in elderly and postpartum patients with moderate-to-severe pulmonary hypertension, with associated comorbidities and type I respiratory failure, with do-not-intubate or defer intubation status. In patients with pulmonary hypertension (PHT) and respiratory failure, endotracheal intubation followed by initiation of mechanical ventilation may have detrimental hemodynamic effects. Increase in lung volumes and decrease in functional residual capacity lead to increase in pulmonary hypertension and right ventricle afterload. If a patient has right heart failure, lung hyperinflation can fatally reduce cardiac output. High-flow nasal oxygen therapy may be of an advantage in these scenarios. How to cite this article: Gupta B, Kerai S, Kakkar K, Gupta L. Role of High-flow Nasal Oxygen Therapy in Cases with Pulmonary Hypertension in an Intensive Care Unit Setting. Indian J Crit Care Med 2019;23(10):458-461.
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The provision of early and adequate nutritional support is vital for the successful recovery from the trauma in any form. Nutritional support is enteral unless specified otherwise as dictated by various benefits of the former. Nasogastric tubes provide effective and common mode of enteral feed due to the ease of placement and maintenance. To our knowledge, the late presentation of diaphragmatic hernia with gastric perforation in a trauma patient leading to feed coming through chest tube is very rare of the complications.
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Background and Aims: There is paucity of studies on preoperative risk assessment tools in patients undergoing emergency surgery. The present study evaluated the performance of the Acute Physiology and Chronic Health Evaluation (APACHE) II, American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) surgical risk calculator and American Society of Anesthesiologists (ASA) physical status (PS) classification system in patients undergoing emergency exploratory laparotomy. Methods: This retrospective study included 60 adult patients who underwent emergency exploratory laparotomy for perforation peritonitis. The clinical details, ASA PS classification, laboratory investigations and postoperative course of patients were retrieved from their medical records. Based on these details, APACHE II and ACS-NSQIP were calculated for the patients. The study's primary outcome was the accuracy of the preoperative APACHE II, ACS-NSQIP risk calculator and ASA PS class in predicting the postoperative 30-day mortality of patients. Results: The area under the curve (AUC) of APACHE II, ACS-NSQIP score, and ASA PS classification for mortality 30 days after surgery was 0.737, 0.694 and 0.601, respectively. The P value for the Hosmer-Lemeshow (H-L) test of scoring systems was 0.05, 0.25 and 0.05, respectively. AUC for postoperative complications was 0.799 for APACHE II, 0.683 for ACS-NSQIP and 0.601 for ASA PS classification. H-L test of these scoring systems for complications after surgery revealed P values of 0.62, 0.36 and 0.53, respectively. Conclusion: Compared to the ACS-NSQIP and ASA PS classification system, the APACHE II score has a better discriminative ability for postoperative complications and mortality in adult patients undergoing emergency exploratory laparotomy.
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The Montgomery silicone t-tube used for post-procedural tracheal stenosis has advantage of acting as both stent and tracheostomy tube. The anesthetic management of patient with t-tube in situ poses a challenge. Safe management of such patients requires careful planning. We describe anesthetic management for direct laryngoscopy of a patient with t-tube in situ.
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Background and Aims: Oropharyngeal leak pressure (OLP) of LMA Protector is reported to be higher compared to other second generation supraglottic devices (SGDs) indicating better seal with patient's airway and hence enhanced safety. To ascertain its benefit in patients undergoing surgeries where head and neck position other than neutral is required, we conducted a prospective randomized study to compare OLP of LMA Protector with LMA-ProSeal (PLMA) with head and neck in neutral, extension, flexion, and rotation position. Methods: 80 American Society of Anesthesiologists (ASA) I-II patients aged more than 18 years undergoing elective surgery under general anaesthesia were recruited. Patients were randomized in the LMA Protector or PLMA group. After induction of anaesthesia, OLP was measured in both the groups in different head and neck position. The insertion characteristics of both SGDs were also recorded and compared. Results: The OLP of LMA Protector and PLMA was found to be comparable in neutral head position (p = 0.08). There was no significant difference in OLP of both devices in extension, flexion, or head rotation. In both the study groups, head extension position led to significant decrease in OLP compared to supine position. With the flexion and rotation positioning of head and neck, significant increase in OLP in each group was noted. Conclusion: The OLP of LMA Protector and PLMA are comparable in different head and neck position. With both the devices, there was significant decrease in OLP with extension whereas significant increase was noted in flexion and rotation of head and neck.
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Background and Aims: Genetic polymorphisms contribute to patients' variability in pain perception and response to opioid treatment. The present study evaluated the association of calcitonin gene-related peptide (CGRP) 4218T/C polymorphisms with fentanyl consumption over 24 h postoperatively in patients after major abdominal surgery. Methods: Eighty-five patients undergoing major abdominal surgery under general anaesthesia were recruited. For postoperative analgesia, epidural fentanyl and intravenous paracetamol were provided. The CGRP 4218T/C genotype was analysed, and the association between the genotype of the patient and the total consumption of fentanyl in the first 24 h after surgery was assessed. The association between different genotypes, the severity of postoperative pain and the side effects of opioids were also studied. Results: Our study population distribution included 52.9% of the T/T genotype (wild homozygote), 35.3% of the T/C genotype (heterozygote) and 11.8% of the C/C genotype (mutant homozygote). Mean (standard deviation) total fentanyl consumption in the first 24 h was found to be highest in the C/C group (212.0 [7.5] µg), followed by the T/T group (182.8 [9.9] µg) and was the least in the T/C group (159.6 [7.5] µg). The C/C group reported higher pain scores in all the study periods. There was no significant difference in the side effects of opioids, such as nausea, vomiting, sedation among different genotypes of CGRP 4218T/C. Conclusion: The polymorphism of CGRP 4218T/C affects postoperative pain perception and analgesic consumption. Patients with the C/C genotype had higher postoperative fentanyl consumption and pain scores.
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Background and Aims: The passage of a Ryle's tube through the drain port on the laryngeal mask airway (LMA) ProtectorTM has been reported to be arduous despite the larger gastric channel. There are no studies on the evaluation of the guided insertion of LMA ProtectorTM to achieve adequate gastrointestinal drainage function. Methods: This randomised study included 132 patients who underwent surgery under general anaesthesia. The gum elastic bougie (GEB)-guided insertion of LMA ProtectorTM (group I) was compared with the conventional method (group II), and the alignment of the tip of the drain tube with the oesophagus was assessed. The insertion characteristics of the device, accuracy of LMA ProtectorTM placement, haemodynamic parameters, and post-operative airway morbidity following the insertion of the device were also compared between the two groups. Results: The first-attempt success rate for the placement of LMA ProtectorTM and the patency of oesophagus was higher in group I patients than in group II (100% vs 84.8%; P < 0.001). However, the time taken for device insertion and associated haemodynamic changes were significantly longer in group I. The patients in group I had better visualisation of laryngeal structures. The GEB-assisted insertion of LMA ProtectorTM resulted in less incidence of blood staining at the cuff of the device. Conclusion: GEB-guided insertion of LMA ProtectorTM achieved better oesophageal patency than the conventional insertion method. This method also had higher first-attempt success at the placement of the device and was observed to be less traumatic.
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OBJECTIVE: This prospective randomised double-blind study was conducted to compare the effect of intravenous (IV) with intraperitoneal (IP) administration of clonidine with respect to analgesic efficacy and side effects. METHODS: A total of 60 American Society of Anaesthesiologists (ASA) physical status class I and II patients, aged 35-60 years, undergoing total abdominal hysterectomy, were randomly divided into 2 groups. Standard general anaesthesia technique was used. All the patients in group IV received 3 µg kg-1 of IV clonidine after resection of the uterus along with 0.25% bupivacaine (20 mL intraperitoneally and 10 mL as wound infiltration), whereas patients in group IP received 10 mL of normal saline intravenously and 3 µg kg-1 of clonidine mixed with 0.25% bupivacaine (20 mL intraperitoneally and 10 mL as wound infiltration). Postoperative analgesia was provided with IV diclofenac every 8 hours and IV fentanyl (1 µg kg-1) on demand. Pain at rest, opioid consumption, level of sedation and severity of nausea were recorded for 24 hours. The heart rate (HR) and blood pressure (BP) were recorded at an interval of 15 minutes for 2 hours followed by routine hourly monitoring. RESULTS: Both the groups were found to be similar with respect to demography and ASA physical status. The maximum pain was felt at 6 hours in both the groups. The mean visual analogue scale score at 6 hours (p=0.47) was comparable. However, patients in group IV had significantly higher sedation (p<0.001) and nausea (p=0.013) scores on arrival at post-anaesthesia care unit along with a significant reduction in HR (p=0.001) and BP (p=0001) for the first 2 hours postoperatively. CONCLUSION: Although IP clonidine is comparable with IV clonidine with respect to postoperative pain scores and supplementary opioid requirement, the side effects are significantly less with IP clonidine.
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BACKGROUND AND AIMS: Thermosoftening of endotracheal tube (ETT) is a simple method which reduces risk of epistaxis during nasotracheal intubation (NTI). This method, however, decreases the stiffness of ETT and necessitates frequent manipulation with Magill forceps. Cuff inflation technique has been found effective for navigating ETTs during NTI. Another method is using an ETT, modified with a silk thread which can be used to control its curvature. We conducted the present study to compare the ease of navigation of thermosoftened ETT using curvature control modificationwiththe cuff inflation technique. METHODS: Depending on the method used for navigating thermosoftened ETT to glottis, 70 patients undergoing general anaesthesia with NTI were randomly divided into two groups. The primary outcome was ease of navigation of thermosoftened ETT. Secondary outcomes were time taken for moving tube from oropharynx to glottis and incidence of epistaxis during NTI. RESULTS: Both techniques resulted in successful navigation of thermosoftened ETT in all patients with majority of cases resulting in smooth engagement to glottic inlet. The difference in ease of navigation between the groups was 7% [95% CI (-9.21% to 23.28%)] and it was not found to be statistically significant (P = 0.395). Cuff inflation method resulted in faster alignment to glottis compared to use of modified tube (12. 39 ± 7 Vs 18.73 ± 11.5 sec; P = 0.003). CONCLUSION: For thermosoftened ETT, both cuff inflation method and the technique of curvature controlled modified ETT can be used for navigation of tube to glottis with ease.
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Surgery in a patient with unrecognised pregnancy has serious ethical and medicolegal implications. There are no guidelines in India for preoperative pregnancy testing (POPT) in surgical patients. This review was undertaken to ascertain utility of routine POPT and whether any specific indication for POPT could be suggested. We performed a literature search to identify publications pertaining to POPT in surgical patients. Searches included PubMed, Google Scholar and internet search for national guidelines. Studies pertaining to incidence of unrecognised pregnancy, cost-effectiveness of POPT, effect of surgery and anaesthesia on pregnancy are included. We excluded articles which were available in languages other than English and those whose full texts were unavailable. Most of the literature about reproductive outcomes after anaesthesia exposure is based on old data. The evidence for teratogenic effect of anaesthetic drugs on human foetus is still inconclusive. Apart from anaesthesia and surgery, the outcome after surgery in unrecognised pregnant patient depends on other factors such as indication for surgery, high incidence of foetal loss in early pregnancy, stress and lifestyle of patient. As it is difficult to unsnarl the effect of these factors, POPT should be offered to all patients who based on history could be possibly pregnant. The cost-effectiveness of POPT appears doubtful, but considering costs associated with miscarriages and medicolegal litigations due to unclear association with anaesthesia, it may indeed be cost-effective.