Comparison of intravenous Magnesium Sulphate combined with Acetaminophen versus intravenous Nalbuphine in COPD patients undergoing elective Cholecystectomy
The objective of this study is to compare the analgesic efficacy of non-opioid anesthesia (NOA) using intravenous magnesium sulphate combined with intravenous acetaminophen versus intravenous nalbuphine in chronic obstructive pulmonary disease patients undergoing elective laparoscopic cholecystectomy.
Design
A Non-Blinded randomized control trial, Single center study with two intervention groups including a sample size of 110 patients
Settings and conduct
Quasi experimental Non-Blinded Study was conducted in Department of Anaesthesia Combined Military Hospital Rawalpindi. The Method of Sampling was Non-randomized trial with Sample size of 110 (55 in each of the two groups)
Participants/Inclusion and exclusion criteria
Inclusion criteria included all American Society of Anaesthesiology Class II and III patients of Chronic obstructive pulmonary disease diagnosed by pulmonary function test with optimized diasease between ages 45-70 years presenting in the general surgical department for elective cholecystectomy for cholelithiasis.
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, Magnesium Sulphate (MgSO4) or Nalbuphine and patients unwilling to be included in the study.
Intervention groups
The study method included all patients as per the inclusion criteria furnished. The patients were divided into Group M (n=55) receiving Magnesium Sulphate (MgSO4) and Acetaminophen and Group N (n=55) receiving nalbuphine.
Main outcome variables
Primary outcome variables measured were intraoperative mean heart rate, mean arterial pressure, time to rescue analgesia and median pain scores at 1, 3 and 6 hour intervals. Secondary outcome variables were the incidence of hypotension, respiratory depression, nausea and vomiting between both groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230819059186N2
Registration date:2024-01-21, 1402/11/01
Registration timing:registered_while_recruiting
Last update:2024-01-21, 1402/11/01
Update count:0
Registration date
2024-01-21, 1402/11/01
Registrant information
Name
Syed Aqib Ali Shah
Name of organization / entity
Combined Military Hospital Rawalpindi Punjab pakistan
Country
Pakistan
Phone
+92 51 9273426
Email address
aqibalishahsyed@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-02, 1402/05/11
Expected recruitment end date
2024-02-02, 1402/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous Magnesium Sulphate combined with Acetaminophen versus intravenous Nalbuphine in COPD patients undergoing elective Cholecystectomy
Public title
Comparison of intravenous Magnesium Sulphate combined with Acetaminophen versus intravenous Nalbuphine in COPD patients undergoing elective Cholecystectomy
Purpose
Treatment
Inclusion/Exclusion 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:
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.
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee institutional review board Combined Military Hospital Rawalpindi
Street address
26 No Road Saddar Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2023-08-24, 1402/06/02
Ethics committee reference number
430
Health conditions studied
1
Description of health condition studied
Analgesic efficacy of Non opioid Anaesthesia (NOA)
ICD-10 code
Z82.5
ICD-10 code description
Family history of Asthma and other Chronic lower respiratory diseases
Primary outcomes
1
Description
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
2
Description
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
3
Description
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)
4
Description
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 outcomes
1
Description
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
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in Group N received Nalbuphine 0.15 mg/kg diluted in 100 ml normal saline over 15 minutes before induction.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital Rawalpindi Pakistan
Full name of responsible person
Syed Aqib Ali Shah
Street address
26 No saddar Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 335 5562605
Email
aqibalishahsyed@gmail.com
Web page address
https://numspak.edu.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Combined Military Hospital Rawalpindi Pakistan
Full name of responsible person
Syed Aqib Ali Shah
Street address
26 No Saddar Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 335 5562605
Email
aqibalishahsyed@gmail.com
Web page address
https://numspak.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Combined Military Hospital Rawalpindi Pakistan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi Pakistan
Full name of responsible person
Syed Aqib Ali Shah
Position
Resident Anaesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 26 saddar Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 9273426
Email
aqibalishahsyed@gmail.com
Web page address
https://numspak.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi Pakistan
Full name of responsible person
Dain bin khalid
Position
Resident Anaesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No 26 Saddar Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 9273426
Email
aqibalishahsyed@gmail.com
Web page address
https://numspak.edu.pk/
Person responsible for updating data
Contact
Name of organization / entity
Combined Military Hospital Rawalpindi Pakistan
Full name of responsible person
Munim ilyas
Position
Resident Anaesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 26 Saddar Rawalpindi Pakistan
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 51 9273426
Email
aqibalishahsyed@gmail.com
Web page address
https://numspak.edu.pk/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available