Back to resultsThe Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
Primary Purpose
Cholelithiasis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ketamine Hydrochloride
Sponsored by
About this trial
This is an interventional prevention trial for Cholelithiasis
Eligibility Criteria
Inclusion Criteria:
- all ASA 1 and 2 patients undergoing Laparoscopic Cholecystectomy electively.
Exclusion Criteria:
- Hepatic and renal disease and ASA 3 and 4 patients.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Ketamine group (Group K)
Saline group (Group S)
Arm Description
Group K was given ketamine @ 0.5mg/kg (prepared by dilution in 0.9% normal saline in 10 ml syringe) at the time of wound closure.
Group S was given saline in 10 ml syringe
Outcomes
Primary Outcome Measures
pain score using Visual Analogue scale, ranging from 0 (minimum) and 10 (maximum), 3 and below showing no pain and scores above 3 showing moderate to severe pain.
Change in pain score using Visual Analogue Scale
Secondary Outcome Measures
narcotic consumption in the post operative anaesthesia care unit
requirement of narcotic in the post anaesthesia care unit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05444777
Brief Title
The Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
Official Title
The Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2013 (Actual)
Primary Completion Date
November 30, 2013 (Actual)
Study Completion Date
November 30, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This double-blinded randomized control trial aims to analyze the effect of low dose Ketamine on narcotic consumption, in patients undergoing Laparoscopic cholecystectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized control trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blinded
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine group (Group K)
Arm Type
Experimental
Arm Description
Group K was given ketamine @ 0.5mg/kg (prepared by dilution in 0.9% normal saline in 10 ml syringe) at the time of wound closure.
Arm Title
Saline group (Group S)
Arm Type
Other
Arm Description
Group S was given saline in 10 ml syringe
Intervention Type
Drug
Intervention Name(s)
Ketamine Hydrochloride
Other Intervention Name(s)
ketasol
Intervention Description
Ketamine was given prior to wound closure.
Primary Outcome Measure Information:
Title
pain score using Visual Analogue scale, ranging from 0 (minimum) and 10 (maximum), 3 and below showing no pain and scores above 3 showing moderate to severe pain.
Description
Change in pain score using Visual Analogue Scale
Time Frame
Baseline on arrival in the post anaesthesia care unit and then every fifteen minutes unto one hour
Secondary Outcome Measure Information:
Title
narcotic consumption in the post operative anaesthesia care unit
Description
requirement of narcotic in the post anaesthesia care unit
Time Frame
postoperatively, after arrival in the post anaesthesia care unit at every fifteen minutes unto one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all ASA 1 and 2 patients undergoing Laparoscopic Cholecystectomy electively.
Exclusion Criteria:
Hepatic and renal disease and ASA 3 and 4 patients.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Low Dose Ketamine on Narcotic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
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