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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by B.P. Koirala Institute of Health Sciences.
Recruitment status was  Recruiting
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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

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

ClinicalTrials.gov processed this record on October 23, 2014