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Effect of Intraperitoneal Nebulisation of Magnesium Sulphate for Analgesia Following Laparoscopic Cholecystectomy

This study is currently recruiting participants.
Verified February 2012 by B.P. Koirala Institute of Health Sciences
Sponsor:
Information provided by (Responsible Party):
sujata niroula, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier:
NCT01542697
First received: February 27, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted
  Purpose

intraperitoneal nebulisation with magnesuim sulphate will reduce post operative pain and analgesic consumption in postoperative period following laparoscopic cholecystectomy.


Condition Intervention Phase
Postoperative Pain
 Drug: intraperitoneal nebulisation of magnesium sulphate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase IV Recruiting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by B.P. Koirala Institute of Health Sciences:

Primary Outcome Measures:
  • number of analgesic request [ Time Frame: 24 hour ] [ Designated as safety issue: No ]

    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 [ Time Frame: first complaint of pain, 6 hrs, 12 hrs, 24 hrs ] [ Designated as safety issue: No ]
    Visual analogue scale is a linear 10cm scale with 0 corresponding to no pain and 10 to worst pain ever

  • nausea and vomiting [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • respiratory rate [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
  • sedation [ Time Frame: 24hrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: intraperitoneal nebulisation of magnesium sulphate
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
 Drug: intraperitoneal nebulisation of magnesium sulphate
intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: ASA I-II

-

Exclusion Criteria: history of

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542697

Contacts
Contact: Sujata Niroula, MD 00977-9842108624 drsujataniroula@gmail.com
Contact: krishna Pokharel, MD 00977-9841986321 drkrishnapokharel@gmail.com

Locations
Nepal
routine operation theatre of BPKoirala Recruiting
Dharan, Nepal, 00977
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Investigators
Study Director: krishna Pokharel, MD B.P. Koirala Institute of Health Sciences
  More Information

Publications:

Responsible Party: sujata niroula, junior resident, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT01542697     History of Changes
Other Study ID Numbers: 698/067/068
Study First Received: February 27, 2012
Last Updated: February 27, 2012
Health Authority: Nepal: Health Research Council

Keywords provided by B.P. Koirala Institute of Health Sciences:
magnesium sulpahate
postoperative analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 19, 2013