Comparison of intravenous Magnesium Sulphate combined with Acetaminophen versus intravenous Nalbuphine in COPD patients undergoing elective Cholecystectomy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230819059186N2

Enrollment

110

Registered

2024-01-21

Start date

2023-08-02

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesic efficacy of Non opioid Anaesthesia (NOA). Family history of Asthma and other Chronic lower respiratory diseases

Interventions

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 minu

Eligibility

Sex/Gender

All

Age

45 Years to 70 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Secondary

Measure	Time frame
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.	—

Countries

Pakistan

Contacts

Public ContactSyed Aqib Ali Shah

Combined Military Hospital Rawalpindi Pakistan

aqibalishahsyed@gmail.com+92 51 9273426

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026