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IRCT20230819059186N2 IRCT 2024-01-21 Combined Military Hospital Rawalpindi Pakistan Comparison of intravenous Magnesium Sulphate combined with Acetaminophen versus intravenous Nalbuphine in COPD patients undergoing elective Cholecystectomy Comparison of intravenous Magnesium Sulphate combined with Acetaminophen versus intravenous Nalbuphine in COPD patients undergoing elective Cholecystectomy 2023-08-02 anticipated 110 Complete https://irct.ir/trial/72411 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Analgesic efficacy of Non opioid Anaesthesia (NOA). Intervention 1: Intervention group 1: Patients in Group M received intravenous MgSO4 at 50 mg/kg diluted in 100 ml of normal saline over 15 minutes with intravenous acetaminophen 15 mg/kg over 15 minutes before induction of anesthesia. Intervention 2: Intervention group 2: Patients in Group N received Nalbuphine 0.15 mg/kg diluted in 100 ml normal saline over 15 minutes before induction. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It will be decided in due course of time
public Syed Aqib Ali Shah
No 26 saddar Rawalpindi
Rawalpindi Pakistan 46000 +92 51 9273426 aqibalishahsyed@gmail.com Combined Military Hospital Rawalpindi Pakistan scientific Dain bin khalid
No 26 Saddar Rawalpindi
Rawalpindi Pakistan 46000 +92 51 9273426 aqibalishahsyed@gmail.com Combined Military Hospital Rawalpindi Pakistan Pakistan Included all ASA-II and III patients of COPD diagnosed by PFTs (pulmonary function test) with optimized diasease Patient with age between 45-70 years presenting in the general surgical department for elective cholecystectomy for cholelithiasis. 45 years 70 years Both Included patients with major cardiac or respiratory disease, low ejection fraction, unoptimized for hypertension or diabetes, patients with cholecystitis Patients allergic to acetaminophen, MgSO4 or nalbuphine and patients unwilling to be included in the study. Z82.5 Family history of Asthma and other Chronic lower respiratory diseases Treatment - Drugs Treatment - Drugs Intervention group 1: Patients in Group M received intravenous MgSO4 at 50 mg/kg diluted in 100 ml of normal saline over 15 minutes with intravenous acetaminophen 15 mg/kg over 15 minutes before induction of anesthesia Intervention group 2: Patients in Group N received Nalbuphine 0.15 mg/kg diluted in 100 ml normal saline over 15 minutes before induction. Per-Operative Mean Heart Rate. Timepoint: Mean heart rate (HR) was observed between both groups per-operatively 15 minutes after surgical incision (HR 1) and 15 minutes before extubation (HR 2). Method of measurement: Standard Monitoring with ECG leads attached to the patients. Per-Operative Mean Arterial Pressure. Timepoint: Mean arterial pressure (MAP) were observed between both groups per-operatively 15 minutes after surgical incision (MAP 1) and 15 minutes before extubation (MAP 2). Method of measurement: Non-Invasive Blood Pressure Measurement. Time to Rescue Analgesia. Timepoint: Once the pain score on the visual analog scale (VAS) were above 4. Method of measurement: Visual analog scale (VAS). Post-Operative Analgesic efficacy. Timepoint: Observed at 1,3 & 6 hrs. Method of measurement: Median Pain Score at 1,3 & 6 hrs and Visual analog scale (VAS). Post-Operative Respiratory depression. Timepoint: Observed 6hrs post operatively. Method of measurement: Clinical assessment of Respiratory Rate, Pattern of breathing and Oxygen Saturation was observed using Pulse Oximetry. Combined Military Hospital Rawalpindi Pakistan Approved 2023-08-24 Ethical committee institutional review board Combined Military Hospital Rawalpindi 26 No Road Saddar Rawalpindi Rawalpindi Punjab Pakistan