Effect of Intraperitoneal Nebulisation of Magnesium Sulphate for Analgesia Following Laparoscopic Cholecystectomy
Phase IV Recruiting
1 other identifier
interventional
60
1 country
1
Brief Summary
intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and analgesic consumption in postoperative period following laparoscopic cholecystectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 postoperative-pain
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMarch 2, 2012
February 1, 2012
1 year
February 27, 2012
February 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
24 hour
Secondary Outcomes (4)
VAS score
first complaint of pain, 6 hrs, 12 hrs, 24 hrs
nausea and vomiting
24 hrs
respiratory rate
24 hrs
sedation
24hrs
Study Arms (2)
Magnesium sulphate
ACTIVE COMPARATORintraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline at the end of surgery before closure
normal saline
PLACEBO COMPARATORintraperitoneal nebulisation of 5 ml of normal saline after end of surgery before closure
Interventions
intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
routine operation theatre of BPKoirala
Dharān, 00977, Nepal
Related Publications (2)
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.
PMID: 17180268BACKGROUNDAbdel - 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
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
krishna Pokharel, MD
B.P. Koirala Institute of Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- junior resident
Study Record Dates
First Submitted
February 27, 2012
First Posted
March 2, 2012
Study Start
June 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 2, 2012
Record last verified: 2012-02