Effect of protocol-based family visitation on physiological indicators in ICU patients: a randomized controlled trial.

BACKGROUND: Intensive care unit (ICU) patients often experience significant physiological stress. This study evaluated the effect of a defined family visitation protocol on physiological responses in the ICU. METHODS: A randomized, block-randomized clinical trial was conducted on 78 ICU patients at Imam Reza Hospital between February 8, 2017, and August 8, 2017. The intervention group received protocol-based visits, and the control group continued with standard visitation. Block randomization was utilized for group assignments. The primary outcome was the measurement of physiological signs using designated monitoring devices. Data were analyzed using SPSS version 22, employing independent t-tests, Mann-Whitney U test, repeated measures analysis, and Friedman's test. RESULTS: The results showed no significant differences in systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, and arterial blood oxygen levels between the two groups. However, heart rate in the intervention group was significantly lower in three stages before, during, and after the meaningful visiting (P = 0.008). CONCLUSION: Protocol-based scheduled family visits in the ICU may reduce physiological stress, as evidenced by a decrease in patients' heart rate. Implementing tailored visitation protocols sensitive to patient preferences and clinical contexts is advisable, suggesting the integration of family visits into standard care practices for enhanced patient outcomes. TRIAL REGISTRATION: IRCT20161229031654N2; 25/01/2018; Iranian Registry of Clinical Trials ( https://en.irct.ir ).

METHYLENE BLUE FOR TREATMENT OF HOSPITALIZED COVID-19 PATIENTS: A RANDOMIZED, CONTROLLED, OPEN-LABEL CLINICAL TRIAL, PHASE 2.

BACKGROUND: There is no pharmacological intervention on the treatment of hypoxemia and respiratory distress in COVID-19 patients. OBJECTIVE: The objective of the study was to study the effect of the reduced form of methylene blue (MB) on the improvement of oxygen saturation (SpO2) and respiratory rate (RR). METHODS: In an academic medical center, 80 hospitalized patients with severe COVID-19 were randomly assigned to receive either oral MB along with standard of care (SOC) (MB group, n = 40) or SOC only (SOC group, n=40). The primary outcomes were SpO2 and RR on the 3rd and 5th days. The secondary outcomes were hospital stay and mortality within 28 days. RESULTS: In the MB group, a significant improvement in SpO2 and RR was observed on the 3rd day (for both, p < 0.0001) and also the 5th day (for both, p < 0.0001). In the SOC group, there was no significant improvement in SpO2 (p = 0.24) and RR (p = 0.20) on the 3rd day, although there was a significant improvement of SpO2 (p = 0.002) and RR (p = 0.01) on the 5th day. In the MB group in comparison to the SOC group, the rate ratio of increased SpO2 was 13.5 and 2.1 times on the 3rd and 5th days, respectively. In the MB group compared with the SOC group, the rate ratio of RR improvement was 10.1 and 3.7 times on the 3rd and 5th days, respectively. The hospital stay was significantly shortened in the MB group (p = 0.004), and the mortality was 12.5% and 22.5% in the MB and SOC groups, respectively. CONCLUSIONS: The addition of MB to the treatment protocols significantly improved SpO2 and respiratory distress in COVID-19 patients, which resulted in decreased hospital stay and mortality. ClinicalTrials.gov: NCT04370288.

Clinical Trial Assessment of Intermittent and Continuous Infusion Dose of N-Acetylcysteine on Redox Status of the Body in Patients with Sepsis Admitted to the ICU.

PURPOSE: Conflicting results exist regarding the efficacy of N-acetyl cysteine (NAC) in sepsis treatment. A pivotal factor affecting the therapeutic potency of NAC in sepsis is timing and dosing of its infusion. We aimed to assess the effect of NAC on redox status of patients with sepsis and to compare its efficacy in intermittent and continuous infusion with the objective of developing the infusion regimen and optimizing the timing. MATERIALS AND METHODS: A prospective, randomized clinical trial was designed to compare the antioxidative effect of NAC in intermittent infusion group (IV: 25 mg/kg bolus and then 25 mg/kg/8 hours 3 times) and continuous infusion group (IV: 25 mg/kg bolus and then 75 mg/kg over 24 hours) in 60 critically ill patients with sepsis (20 patients in each group). Blood samples were collected immediately before and after intervention for total antioxidant capacity (TAC) and malondialdehyde (MDA) assessment. RESULTS: N-acetyl cysteine considerably increased TAC levels in both intermittent (0.68 ± 0.60; P value = .036) and continuous (0.69 ± 0.64; P value = .015) infusion groups when compared to placebo (0.61 ± 0.10); however, the difference in TAC levels between the intermittent and the continuous infusion did not reach statistical significance (P value = .942). Likewise, NAC treatment decreased MDA levels in both intermittent (19.45 ± 4.18; P value = 0.001) and continuous (22.47 ± 6.68; P value = .002) infusion groups when compared to placebo (31.76 ± 11.06), while the difference in MDA levels between the intermittent and the continuous infusion did not reach statistical significance (P value = .481). CONCLUSION: Our data confirmed the antioxidative effect of NAC treatment in patients with sepsis, with no significant difference in intermittent and continuous infusion.

Evaluation of Amino Acid Infusion preventive effect on Hypothermia during Spinal Anesthesia for Hip Arthroplasty.

Background: Hypothermia increases bleeding during surgery, risk of ischemic heart disease and postoperative wound infection. Intravenous amino acid increases cell synthesis and produces heat. Our goal was evaluating of the effect of amino acid on intraoperative hypothermia under spinal anesthesia. Methods: This is a randomized, double-blinded clinical trial that 36 adults undergoing Hip Arthroplasty were randomly assigned into two groups of 18 each. One group received Amino Acids solution (Aminoven 10%) 500ml (240ml/h) throughout spinal anesthesia, and control group received saline solution. We measured core body temperature, MAP and HR each 10 minutes, and also postoperative shivering, blood loss, operation time, postoperative BUN and Cr were compared in two groups. Results: Throughout surgery, the reduction in core temperature was more in the control group than the amino acids group (statistically not clinically). The decrease in core temperature was significantly larger in the controls (0.96°C ± 0.7°C) than in the amino acid patients (0.94°C ± 0.4°C), (P value= 0.02). Postoperative shivering was 73% in the controls regarding 11% in the amino acids patients. Overall, there were no significant statistical differences between other variables that we measured in two groups of patients. Conclusion: Amino acids infusion during spinal anesthesia exerted a thermogenic effect. Our findings showed hypothermia was less in the aminoacid group, and also postoperative shivering was more in the control group.

The Effect of Spinal and General Anesthesia on Serum Lipid Peroxides and Total Antioxidant Capacity in Diabetic Patients with Lower Limb Amputation Surgery.

BACKGROUND: Anesthesia is performed in two major methods including regional and general.The aim of this study was to compare the effect of anesthesia method (spinal and general) on oxidative stress in diabetic patients underwent diabetic amputation surgery. METHODS: In this randomized control trial, 40 patients with diabetic foot who were candidate for foot amputation surgery at our academic hospital in 2013, were selected and divided into two groups based on anesthesia method. Lipid peroxide level and serum total antioxidant capacity (TAC) were measured before anesthesia induction and one hour after surgery. As the normal range, the findings obtained from 23 healthy volunteers were utilized. RESULTS: ean age was 54.9±11.21 and 52.4±11.23 years in the spinal anesthesia (SA) and the general anesthesia (GA) group, respectively (P=0.49). Serum TAC in GA group increased from 1.03±0.04 mM to 2.98±0.7 mM. In SA group, the increase of serum TAC from 1.22±0.11 mM to 3.42±0.5 mM was observed that indicated the increase of serum TAC in both groups was not significantly different (P=0.21). Serum Malondialdehyde (MDA) in GA and SA groups did not show a significant difference before surgery (31.14±3.9 mM vs. 29.06±2.49 mM in GA and SA groups, respectively) (P=0.31), while it was significantly different after surgery (23.14±2.6 mM and 19.24±2.7 mM in GA and SA groups, respectively) (P=0.03). CONCLUSION: lower limb amputation can help to control oxidative stress in diabetic patients; and considering serum MDA as a marker of oxidative stress, SA seems to be more effective to control this problem.

Methylene blue for treatment of hospitalized Covid-19 patients: a randomized, controlled, open-label clinical trial, phase 2

ABSTRACT Background: There is no pharmacological intervention on the treatment of hypoxemia and respiratory distress in COVID-19 patients. Objective: The objective of the study was to study the effect of the reduced form of methylene blue (MB) on the improvement of oxygen saturation (SpO2) and respiratory rate (RR). Methods: In an academic medical center, 80 hospitalized patients with severe COVID-19 were randomly assigned to receive either oral MB along with standard of care (SOC) (MB group, n = 40) or SOC only (SOC group, n=40). The primary outcomes were SpO2 and RR on the 3rd and 5th days. The secondary outcomes were hospital stay and mortality within 28 days. Results: In the MB group, a significant improvement in SpO2 and RR was observed on the 3rd day (for both, p < 0.0001) and also the 5th day (for both, p < 0.0001). In the SOC group, there was no significant improvement in SpO2 (p = 0.24) and RR (p = 0.20) on the 3rd day, although there was a significant improvement of SpO2 (p = 0.002) and RR (p = 0.01) on the 5th day. In the MB group in comparison to the SOC group, the rate ratio of increased SpO2 was 13.5 and 2.1 times on the 3rd and 5th days, respectively. In the MB group compared with the SOC group, the rate ratio of RR improvement was 10.1 and 3.7 times on the 3rd and 5th days, respectively. The hospital stay was significantly shortened in the MB group (p = 0.004), and the mortality was 12.5% and 22.5% in the MB and SOC groups, respectively. Conclusions: The addition of MB to the treatment protocols significantly improved SpO2 and respiratory distress in COVID-19 patients, which resulted in decreased hospital stay and mortality. ClinicalTrials.gov: NCT04370288

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.