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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by sujata niroula, B.P. Koirala Institute of Health Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01542697
First Posted: March 2, 2012
Last Update Posted: March 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
sujata niroula, B.P. Koirala Institute of Health Sciences
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase IV Recruiting

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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

  • nausea and vomiting [ Time Frame: 24 hrs ]
  • respiratory rate [ Time Frame: 24 hrs ]
  • sedation [ Time Frame: 24hrs ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: ASA I-II

Exclusion Criteria: history of

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 27, 2012
First Posted: March 2, 2012
Last Update Posted: March 2, 2012
Last Verified: February 2012

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

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