Back to resultsEffect of Intraperitoneal Nebulisation of Magnesium Sulphate for Analgesia Following Laparoscopic Cholecystectomy
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 4
Locations
Nepal
Study Type
Interventional
Intervention
intraperitoneal nebulisation of magnesium sulphate
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring magnesium sulpahate, postoperative analgesia
Eligibility Criteria
Inclusion Criteria: ASA I-II
-
Exclusion Criteria: history of
-
Sites / Locations
- routine operation theatre of BPKoiralaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Magnesium sulphate
normal saline
Arm Description
intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline at the end of surgery before closure
intraperitoneal nebulisation of 5 ml of normal saline after end of surgery before closure
Outcomes
Primary Outcome Measures
number of analgesic request
time to first analgesic request is taken as duration of effective analgesia
number of analgesic request in first 24 hours were also counted
Secondary Outcome Measures
VAS score
Visual analogue scale is a linear 10cm scale with 0 corresponding to no pain and 10 to worst pain ever
nausea and vomiting
respiratory rate
sedation
Full Information
NCT ID
NCT01542697
First Posted
February 27, 2012
Last Updated
February 27, 2012
Sponsor
B.P. Koirala Institute of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01542697
Brief Title
Effect of Intraperitoneal Nebulisation of Magnesium Sulphate for Analgesia Following Laparoscopic Cholecystectomy
Official Title
Phase IV Recruiting
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
B.P. Koirala Institute of Health Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and analgesic consumption in postoperative period following laparoscopic cholecystectomy.
Detailed Description
Sixty patients undergoing laparoscopic cholecystectomy belonging to American Society of Anaesthesiologist (I-II) of age 18-65 yrs will be enrolled.Group one (n=30) will receive 1.5 gm magnesium sulphate diluted in 3ml of normal saline and group 2 (n=30) will receive 5 ml of NS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
magnesium sulpahate, postoperative analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Magnesium sulphate
Arm Type
Active Comparator
Arm Description
intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline at the end of surgery before closure
Arm Title
normal saline
Arm Type
Placebo Comparator
Arm Description
intraperitoneal nebulisation of 5 ml of normal saline after end of surgery before closure
Intervention Type
Drug
Intervention Name(s)
intraperitoneal nebulisation of magnesium sulphate
Intervention Description
intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline
Primary Outcome Measure Information:
Title
number of analgesic request
Description
time to first analgesic request is taken as duration of effective analgesia
number of analgesic request in first 24 hours were also counted
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
VAS score
Description
Visual analogue scale is a linear 10cm scale with 0 corresponding to no pain and 10 to worst pain ever
Time Frame
first complaint of pain, 6 hrs, 12 hrs, 24 hrs
Title
nausea and vomiting
Time Frame
24 hrs
Title
respiratory rate
Time Frame
24 hrs
Title
sedation
Time Frame
24hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-II
-
Exclusion Criteria: history of
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sujata Niroula, MD
Phone
00977-9842108624
Email
drsujataniroula@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
krishna Pokharel, MD
Phone
00977-9841986321
Email
drkrishnapokharel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
krishna Pokharel, MD
Organizational Affiliation
B.P. Koirala Institute of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
routine operation theatre of BPKoirala
City
Dharan
ZIP/Postal Code
00977
Country
Nepal
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
17180268
Citation
Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.
Results Reference
background
Citation
Abdel - Raouf M, Amer H. Postoperative analgesic effects of intraperitoneal NMDA receptor antagonist (ketamine and magnesium sulphate )in patients undergoing laparoscopic cholecystectomy .Eg J Anaesth. 2004;20: 107-11
Results Reference
background
Learn more about this trial
Effect of Intraperitoneal Nebulisation of Magnesium Sulphate for Analgesia Following Laparoscopic Cholecystectomy
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