Comparison of Analgesic Effects of Ketorolac Plus Apotel to Meperidine in Patients Undergoing Right Thoracotomy: A Double-Blind Randomized Clinical Trial.

Background: Postoperative pain management using nonsteroidal anti-inflammatory drugs with no narcotic-attributed adverse effects, such as respiratory depression, nausea, and vomiting, is still the subject of extensive research. However, concerns about bleeding and nephrotoxicity have limited routine use. Objectives: The present trial aimed to compare the effects of ketorolac/apotel and meperidine on postoperative pain relief in patients undergoing thoracotomy. Methods: This randomized controlled trial enrolled 122 patients who were candidates for right thoracotomy. The patients were randomly divided into two groups that received ketorolac (30 mg)/apotel (1 g) or meperidine (0.5 - 1 mg/kg) at the beginning of recovery, respectively. This study assessed the Numeric Rating Scale pain score immediately and 30 and 60 minutes after the surgery in the recovery room, blood pressure, oxygen saturation (SpO2), sweating, and pulse rate. Results: The average pain score at recovery time was significantly lower in the ketorolac/apotel group (2.06 ± 1.40) than in the meperidine group (2.76 ± 1.61) (P = 0.011). In contrast to the ketorolac/apotel group, an increasing trend was observed in pain scores in the meperidine group throughout the time sequence (P < 0.05). However, a slight non-significant increase was also observed in the ketorolac/apotel group. No statistical differences were observed in blood pressure (P = 0.826), SpO2 (P = 0.826), and pulse rate (P = 0.811) between the two study groups. Conclusions: This study provides support that the combination of ketorolac/apotel offers a slightly superior analgesic effect for patients undergoing thoracotomy, compared to meperidine. Pain management is crucial during recovery, and the current study's findings suggest that administering ketorolac/apotel provides effective analgesia during recovery after thoracic surgery.

Effects of glargine on hyperglycemia in patients with diabetes mellitus type II undergoing off-pump coronary artery bypass graft: A randomized, controlled, double-blind clinical trial.

Introduction: In this trial, effects of glargine on hyperglycemia in patients with diabetes mellitus type II who were undergoing off-pump coronary artery bypass graft (CAGB), were examined. Methods: Seventy diabetic patients who were candidate for off-pump CABG were randomly divided into the following two groups (1) Control group who were treated with normal saline+regular insulin and (2) Glargine group who received glargine+regular insulin. Normal saline and glargine were administered subcutaneously 2 hours before surgery, and regular insulin was injected before, during and after the surgery in the intensive care unit (ICU) in both groups. Finally, levels of blood sugar before, 2 hours after starting the surgery and at the end of the surgery, were recorded. Blood sugar levels during ICU stay were also measured every 4 hours for 36 hours. Results: There were no significant differences in blood sugar levels between the groups at the three time points (i.e. before, 2 hours after starting the surgery and at the end of the surgery). In addition, during 36 hours of ICU stay, blood sugar levels did not show significant variations between the groups; however, 20 hours after ICU admission, blood sugar level was significantly higher in the glargine group (P=0.04). Conclusion: The results indicated that both glargine and regular insulin effectively control the blood glucose in diabetic patients undergoing CABG. However, the blood sugar fluctuation was less in the glargine group than control group.

Intra-articular remifentanil on postoperative pain in knee arthroscopic surgery; a double blind randomized clinical trial.

BACKGROUND: We aimed to assess the efficacy of intra-articular remifentanil in relieving postoperative pain after knee arthroscopy. METHODS: We conducted a double-blind randomized clinical trial study on 60 patients. Patients were divided into two equal groups. The control group received 25 ml of intra-articular normal saline, and the intervention group received 200 µg of remifentanil dissolved in 25 ml of saline. We evaluated at rest postoperative pain at 1, 3, 6, 12, 18, and 24 h after the surgery using the Visual Analog Scale (VAS). Patients with VAS scores of 4 or more received meperidine (pethidine). The first time meperidine was requested and the total amount of meperidine consumed was recorded. RESULTS: Out of 60 patients, 49 were male (81.6%), and the mean age of participants was 32.71 (7.02) years. An hour after the surgery, the control group showed a mean VAS score of 8.66 (1.26), and decreased to 2.53 (1.67) at the end of 24 h. The intervention group started with a mean VAS score of 2.23 (1.81) and ended at 0.10 (0.305). All patients in the control group and 11 (36.7%) patients in the intervention group asked for analgesics during follow-up. The mean total meperidine dose in the control and intervention groups was 108.33 (23.97) mg and 13.33 (19.40) mg, respectively (P < 0.001; 95% confidence interval of the difference 83.72 to 106.27). CONCLUSIONS: Intra-articular remifentanil may decrease postoperative pain and analgesic requirements in patients undergoing knee arthroscopy.

The Effect of Preoperative Sublingual Melatonin on Postoperative Pain Severity in Patients Undergoing Colorectal Surgery: A Triple-Blinded Randomized Trial.

Background: Postoperative pain has detrimental physiologic and psychologic effects on patients' outcomes, such as increased postoperative morbidity, delayed recovery, and reduced patient satisfaction. This study aimed to determine the effect of preoperative sublingual melatonin on pain severity after colorectal surgery. Methods: We performed a randomized, placebo-controlled, triple-blinded study to test the efficacy of 6 mg of sublingual melatonin or placebo 1 hour preoperative on pain severity and sedation of 60 patients after colorectal surgeries. Pain and sedation were assessed by numerical verbal response (NVR) and the Ramsey sedation score, respectively, at the baseline, 1, 2, 6, 12, and 24 hours after surgery. The repeated measures analysis of variance was used to assess group × time interaction, and the Bonferroni adjustment was used for between-group comparisons. Results: A total of 60 patients with a mean ± SD age of 49.35 years were equally randomized to the study groups. There was no significant difference between groups with respect to the baseline characteristics. The mean score of pain severity of patients in the melatonin group was significantly lower compared with the placebo group at 2, 6, 12, and 24 hours after surgery. The total mean pain score for the first 12 hours (mean difference [MD] [SE], 0.41 [0.12]; 95% CI, 0.17-0.65; [P = 0.012]) and the mean score of pain in 24 hours after surgery were significantly lower in the melatonin group in comparison with the placebo group (MD [SE], 0.44 [0.13]; 95% CI, 0.19-0.69; [P = 0.001]). Compared with the placebo group, the percent of patients who were cooperative, aware, and calm was significantly higher in the melatonin group at the baseline (43.3% vs 53.3%) and at 1 (36.7% vs 60%) and 2 hours (33.3% vs 80%). Conclusion: The use of 6 mg preoperative melatonin sublingual tablet in patients with colorectal surgeries could reduce the severity of postoperative pain, patients' restlessness and anxiety, and increase patients' cooperation and calmness. Therefore, it seems that sublingual melatonin is an effective drug in controlling postoperative pain.

Prophylactic Effects of Ephedrine, Ondansetron and Ringer on Hemodynamic Changes during Cesarean Section under Spinal Anesthesia - a randomized clinical trial.

BACKGROUND: Hemodynamic change during spinal anaesthesia for cesarean section is prevalent. OBJECTIVE: Comparing the prophylactic effects of ephedrine, ondansetron and ringer on hemodynamic changes in patients undergoing cesarean section with spinal anaesthesia. MATERIAL AND METHODS: This randomized clinical trial was carried out on pregnant women undergoing elective cesarean sec-tion referred to teaching hospitals of Mashhad, Iran. Patients allocated to three groups of intravenous ondansetron (O) (4 mg, 5 min),intramuscular ephedrine (E) (25 mg, 25 min) and ringer (R) (500 ml, 20 min) prior to spinal anaesthesia. Anaesthesia inducted with 10-15 mg of bupivacaine. Vital signs were recorded every 3 minutes for 18 minutes including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), pulse rate (PR), pulse oximetry (SpO2). RESULTS: Ninety patients with a mean age of 29.4 ± 5.4 years were studied in three groups of O (n = 30), E (n = 30), R (n = 30). Results showed a statistically significant difference in the incidence rate of hypotension 12 minutes after spinal anaesthesia in the three groups, but no statistically significant difference was found in the rest of minutes among the three groups. Dur-ing follow-up minutes, bradycardia was observed in only one patient (1.1%) of Group O and no cases of this sign were observed in other minutes and other groups. CONCLUSION: Intramuscular administration of ephedrine 25 minutes prior to the spinal anaesthesia leads to better prevention of systolic blood pressure changes compared with intravenous ondansetron and ringer, while administration of ondansetron and ringer had the same effects on reducing hemodynamic changes.

Effect of propofol and isoflurane on gas exchange parameters following one-lung ventilation in thoracic surgery: a double-blinded randomized controlled clinical trial.

BACKGROUND: The use of anesthetic drugs with minimal inhibitory effects on the hypoxic pulmonary vasoconstriction (HPV) could have a decisive role in preventing the hypoxemia during one-lung ventilation (OLV). OBJECTIVE: The aim of this study was to compare the effects of propofol and isoflurane on the changes in gas exchange parameters following OLV in thoracic surgery. METHODS: This double-blinded randomized controlled clinical trial was conducted on patients who were candidates for elective right thoracotomy referred to the central operating room of Ghaem Hospital in Mashhad, Iran, during February 2016-2017. Patients with age range of 18 to 75 years, class I and II American Society of Anesthesiologists (ASA) and thoracotomy with OLV for pulmonary resection or cyst drainage were included. The patients were randomly allocated (1:1 ratio) into two groups of propofol (P, 50-100µg/kg/min) and isoflurane (I, 1 minimum alveolar concentration (MAC) 1.1%). Partial pressure of carbon dioxide (PaCO2), partial pressure of oxygen (PaO2), end-tidal carbon dioxide (ETCO2) and arterial oxygen saturation (SPO2) were recorded before and 15 minutes after OLV and compared between the two groups. The comparison of the mean gas exchange parameters before and 15 minutes after OLV was performed using Mann-Whitney test in SPSS version 19 software. P<0.05 was considered statistically significant. RESULTS: In this study, 122 patients with mean age of 59.4±14.1 years (two groups of 61) were studied. Both groups were matched for age or gender. The two groups had no significant difference in the gas exchange parameters before the OLV. Only PaCO2 (p=0.001) and ETCO2 (p=0.001) were significantly higher in the propofol group after 15 minutes OLV than in the isoflurane group. However, PaO2 (p=0.67), O2Sat (p=0.333) and PaCO2-ETCO2 gradient (p=0.809) showed no significant difference between the two groups at this minute. CONCLUSION: Based on the results of this study, the propofol or isoflurane selection seems to have no significant effect on the arterial oxygenation. On the other hand, isoflurane and propofol could be an appropriate anesthetic for thoracic surgery by normalizing the carbon dioxide gradient range during the OLV. CLINICAL TRIAL REGISTRATION: The study was also registered at the Iranian Registry of Clinical Trials (IRCT2015123013159N8). FUNDING: The study was financially supported by the Deputy of Research of Mashhad University of Medical Sciences (grant number: 940119).

Effect of oral ginger on prevention of nausea and vomiting after laparoscopic cholecystectomy: a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Postoperative nausea and vomiting (PONV) are among the most frequent complications following laparoscopic cholecystectomy. Recently, some studies have shown ginger, as an herbal medicine, to be effective and safe in PONV prevention; however, there is no evidence of its efficacy in the Iranian population. OBJECTIVE: The aim of this study was to determine the effect of oral ginger on PONV prevention after laparoscopic cholecystectomy. METHODS: This double-blind, randomized, placebo-controlled clinical trial was performed on women who were undergoing laparoscopic cholecystectomy in Imam Raza Hospital, Mashhad, Iran between April and November, 2016. Patients were divided randomly into two groups of G) intervention group (n=75, received 2 capsules containing 250 mg ginger) and P) placebo group (n=75, received 2 placebo capsules) one hour before surgery. Nausea severity and vomiting frequency were evaluated at 2, 4, 6, and 12 hours after the operation. Data analysis was done by SPSS version 16.0 software with Chi-square test, Independent-sample-t-test, repeated measure ANOVA and Mann-Whitney U test. RESULTS: The two groups were homogenous in terms of age, gender and surgery duration. The severity of nausea was lower in the ginger group at the 2, 4, 6, and 12 hours after the operation; however, these differences were statically significant only at 2 (p=0.034) and 12 hours (p=0.043). Although the incidence of vomiting was higher in the placebo group in the 2nd and 12th hours after surgery, the number of vomiting episodes in 2, 4, 6 and 12 hours after surgery was statistically similar in the two groups (p>0.05). The nausea severity was significantly changed during 12 hours of study in both groups (p=0.001), however the nausea severity was always lower in the ginger group (p=0.078). CONCLUSION: This study demonstrated that 500mg oral ginger one hour before surgery in women who were undergoing laparoscopic cholecystectomy is effective in decreasing severity of PONV. TRIAL REGISTRATION: The trial was registered at the Iranian Registry of Clinical Trials (http://www.irct.ir) with the Irct ID: IRCT2016122222218N2. FUNDING: The study was financially supported by Deputy of Research of Mashhad University of Medical Sciences.

Effects of dexmedetomidine on heart arrhythmia prevention in off-pump coronary artery bypass surgery: A randomized clinical trial.

BACKGROUND: Arrhythmia occurring during and after surgery is one of the major complications in open-heart surgery. Dexmedetomidine is an intravenous alpha-2 agonist and very specific short-acting drug to protect the various organs against ischemic injuries and blood reflow. However, the effect of dexmedetomidine for preventing intraoperative heart arrhythmias has not been recognized. OBJECTIVE: This study aimed to determine the effect of dexmedetomidine on the incidence rate of heart arrhythmias and anesthetic required in off-pump coronary artery bypass surgery. METHODS: This randomized clinical trial was conducted on patients who were candidates for off-pump coronary artery bypass referring to Imam Reza Hospital of Mashhad, Iran, from July 2016 through January 2017. The patients were randomly assigned to two groups of intervention (infusion of 0.5 mcg/kg/h dexmedetomidine together with induction followed by infusion of 0.5 mcg/kg/h by the end of the surgery) or control (saline infusion). Mean arterial pressure (MAP) and heart rate (HR) were measured before induction, during surgery operation and ICU admission. Data were analyzed by SPSS version 18 using Chi Square and independent-samples t-test. RESULTS: A total of 76 patients with a mean age of 59.8 ± 8.2 years (in two groups of 38) were studied. The two groups had no statistically significant difference in terms of background variables. The MAP and HR values before induction, during surgery and ICU admission were significantly higher in the control group than in the intervention group (p=0.001). Out of the studied arrhythmias, the values of PAC (55.2% vs. 15.7%), PVC (81.5% vs. 21.0%), AF (26.3% vs. 7.8%), VTAC (21.0% vs. 2.6%) were significantly lower in dexmedetomidine group (p=0.001). CONCLUSION: It seems that dexmedetomidine administration during induction and surgery can cause significant reduction in most of the common arrhythmias in off-pump coronary bypass surgery. The use of dexmedetomidine maintains MAP and HR at significantly lower values, and changes compared to the control group as well as reduces the need for anesthetic compounds. TRIAL REGISTRATION: The present study has been registered at the Iranian Registry of Clinical Trials (www.IRCT.IR) with a code of IRCT2016072413159N9 before starting the study. FOUNDING: This study was fully sponsored by the Research Deputy at Mashhad University of Medical Sciences, Iran (grant number 941413).

Moderate hypothermia and its effects in reducing the applied dose of anesthetics for patients with opium dependence in cardiac surgery: A randomized controlled trial.

BACKGROUND: An increasing number of patients addicted to opium are experiencing awareness during coronary artery bypass surgery (CABG) as a result of tolerance to anesthetics. OBJECTIVES: This research was primarily intended to determine the potential diminishing effects of moderate hypothermia on anesthetic dosage and recall of anesthesia during the procedure. METHODS: In this double-blind randomized controlled trial, a total of 80 CABG candidates with known addiction to opium were divided into two groups: one normothermic (N) and the other moderately hypothermic (H), both undergoing induction as well as close monitoring from September 2014 to January 2016. The candidates were initially set for a target bispectral index (BIS) score of between 40 and 60. As the score rose to 60, an additional dose of propofol was administered, alongside rise in blood pressure and tear-shedding. To enhance the accuracy of our evaluation of anesthetic depth, we also used two questionnaires to test candidates' recall filled with the assistance of a colleague 24 hours following surgery. Independent-samples t-test and chi-square test were used by SPSS v 18 for data analysis. RESULTS: Eighty patients were studied in two groups of normothermic (N) (n = 40) and hypothermic (H) (n = 40). Given similar demographic data as well as the duration of surgery, we arrived at a propofol dose of 122.52±13.11 cc for normothermic patients and 101.28±14.06 cc for hypothermic subjects (p=0.001). As for fentanyl, the total required sum came up to 39.60±21.04 cc and 31.72±5.81 cc for the above-mentioned groups in order (p=0.025). Moreover, the post-operative interview showed that there was no report of a patient with memory recall following surgery. CONCLUSIONS: Moderate hypothermia can substantially reduce the need for anesthetics in patients with addiction to opium when undergoing CABG surgery. TRIAL REGISTRATION: This study is registered in Iranian Registry of Clinical Trials with registration number of IRCT2014050513159N5. FUNDING: This research was supported financially by the Research Council of Mashhad University of Medical Sciences (grant number 920405).

Effect of Entonox on reducing the need for Pethidine and the Relevant Fetal and Maternal Complications for Painless Labor.

BACKGROUND: Pain relief during labour is one of the major concerns in obstetrics; severe labor pain causes fear of the next pregnancy, and interferes with the mother's family relationship. OBJECTIVE: The aim of this study was to evaluate the analgesic effects of Entonox during labor on reducing the need for pethidine (Meperidine) and fetal-maternal complications. METHODS: This double-blind randomized clinical trial was conducted on pregnant women who were candidates for vaginal delivery in Educational Hospitals of Mashhad University of Medical Sciences, Iran between January 2014 and November 2015. After entering into the inactive phase of labor, participants were randomly allocated to receive inhaled Entonox gas (n=200) or inhale Oxygen (n=200) as a control group. Mothers inhaled the gas at commencement of pain, and ceased as soon as the pain diminished, up to the end of the second stage of labor which was the neonate's birth. Main outcomes were pain score based on NRS (numerical rating scale), duration of delivery, required pethidine, maternal complications and satisfaction during labour. Chi-square and Independent T-test were used via SPSS for data analysis and P-value less than 0.05 was considered statistically significant. RESULTS: Four-hundred pregnant women with a mean age of 26.4±5.9 years were studied. Complications such as nausea, vomiting, dizziness, and drowsiness were reported in 25% of the Entonox group and 23% in the control group (p=0.640). Mean of pain severity score during labor in the Entonox and control groups was 4.5±1.2 and 5.2±1.4, respectively (p<0.001). Pethidine requirement, significantly was lower in the Entonox group (31.6±11.8 versus 35.7±12.4; p<0.001). CONCLUSION: In our study, Entonox significantly reduced pain during delivery without significant increase in maternal and neonatal complications. TRIAL REGISTRATION: The trial is registered at the Iranian Clinical Trial Registry (IRCT.ir) with the IRCT identification number IRCT2015102713159N6. FUNDING: This research has been financially supported by Research Council of Mashhad University of Medical Sciences.

The Assessment of Addition of Either Intravenous Paracetamol or Diclofenac Suppositories to Patient-Controlled Morphine Analgesia for Postgastrectomy Pain Control.

BACKGROUND: Major surgical procedures, such as gastrectomy, result in extensive postoperative pain, which can lead to increased morbidity, discomfort and dissatisfaction among the patients. OBJECTIVES: The aim of this study was to evaluate the effect of adding diclofenac suppositories or intravenous paracetamol, on morphine consumption and on the quality of postgastrectomy pain control. PATIENTS AND METHODS: This randomized double blinded clinical trial was carried out in 90 patients with gastric cancer, who were candidates for gastrectomy, which were divided into three similar groups. The patients were transferred to an intensive care unit after the operation and received patient-controlled analgesia (PCA) with morphine, morphine PCA plus intravenous paracetamol 1 g, every 6 hours, and morphine PCA plus diclofenac suppositories, 100 mg every 8 hours. The patients were evaluated for up to 24 hours after the operation for the severity of pain, alertness, and opioid complications. RESULTS: There was no significant difference in pain scores among the three groups (P values, after extubation, at 2, 4, 6, 12, 18 and 24 hours were 0.72, 0.19, 0.21, 0.66, 0.54, 0.56, and 0.25, respectively), although morphine consumption was greater in the morphine group, compared with the other two groups (21.4 ± 7.7 mg in morphine group vs. 14.3 ± 5.8 mg in morphine-paracetamol group and 14.3 ± 3.9 in morphine-diclofenac group; P = 0.001). In morphine group, during the first 24 hours, the patients had lower levels of consciousness (P values, after extubation, at 2, 4, 6, 12, 18 and 24 hour were 0.6, 0.95, 0.28, 0.005, 0.027, 0.022 and 0.004 respectively), even though the incidence of complications was similar among the three groups. CONCLUSIONS: In this study, intravenous paracetamol or diclofenac suppositories, administered for postgastrectomy pain control, decreased morphine consumption by almost 32% and also improved alertness. Nevertheless, the amount of opioids did not affect the incidence of complications.