- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01542697
Effect of Intraperitoneal Nebulisation of Magnesium Sulphate for Analgesia Following Laparoscopic Cholecystectomy
February 27, 2012 updated by: sujata niroula, B.P. Koirala Institute of Health Sciences
Phase IV Recruiting
intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and analgesic consumption in postoperative period following laparoscopic cholecystectomy.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sujata Niroula, MD
- Phone Number: 00977-9842108624
- Email: drsujataniroula@gmail.com
Study Contact Backup
- Name: krishna Pokharel, MD
- Phone Number: 00977-9841986321
- Email: drkrishnapokharel@gmail.com
Study Locations
-
-
-
Dharan, Nepal, 00977
- Recruiting
- routine operation theatre of BPKoirala
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: ASA I-II
-
Exclusion Criteria: history of
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Magnesium sulphate
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 1.5 gm of magnesium sulphate with 2 ml of normal saline
|
Placebo Comparator: normal saline
intraperitoneal nebulisation of 5 ml of normal saline after end of surgery before closure
|
intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of analgesic request
Time Frame: 24 hour
|
time to first analgesic request is taken as duration of effective analgesia number of analgesic request in first 24 hours were also counted |
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS score
Time Frame: first complaint of pain, 6 hrs, 12 hrs, 24 hrs
|
Visual analogue scale is a linear 10cm scale with 0 corresponding to no pain and 10 to worst pain ever
|
first complaint of pain, 6 hrs, 12 hrs, 24 hrs
|
nausea and vomiting
Time Frame: 24 hrs
|
24 hrs
|
|
respiratory rate
Time Frame: 24 hrs
|
24 hrs
|
|
sedation
Time Frame: 24hrs
|
24hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: krishna Pokharel, MD, B.P. Koirala Institute of Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Anticipated)
June 1, 2012
Study Completion (Anticipated)
June 1, 2012
Study Registration Dates
First Submitted
February 27, 2012
First Submitted That Met QC Criteria
February 27, 2012
First Posted (Estimate)
March 2, 2012
Study Record Updates
Last Update Posted (Estimate)
March 2, 2012
Last Update Submitted That Met QC Criteria
February 27, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- 698/067/068
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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