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

NCT ID: NCT01542697

Last Updated: 2012-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Magnesium sulphate

intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline at the end of surgery before closure

Group Type ACTIVE_COMPARATOR

intraperitoneal nebulisation of magnesium sulphate

Intervention Type DRUG

intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline

normal saline

intraperitoneal nebulisation of 5 ml of normal saline after end of surgery before closure

Group Type PLACEBO_COMPARATOR

intraperitoneal nebulisation of magnesium sulphate

Intervention Type DRUG

intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline

Interventions

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intraperitoneal nebulisation of magnesium sulphate

intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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sujata niroula

junior resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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krishna Pokharel, MD

Role: STUDY_DIRECTOR

B.P. Koirala Institute of Health Sciences

Locations

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routine operation theatre of BPKoirala

Dharān, , Nepal

Site Status RECRUITING

Countries

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Nepal

Central Contacts

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Sujata Niroula, MD

Role: CONTACT

00977-9842108624

krishna Pokharel, MD

Role: CONTACT

00977-9841986321

References

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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.

Reference Type BACKGROUND
PMID: 17180268 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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698/067/068

Identifier Type: -

Identifier Source: org_study_id

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