NCT05444777

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2013

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

March 17, 2021

Last Update Submit

July 10, 2023

Conditions

Cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline on arrival in the post anaesthesia care unit and then every fifteen minutes unto one hour

Secondary Outcomes (1)

  • narcotic consumption in the post operative anaesthesia care unit

    postoperatively, after arrival in the post anaesthesia care unit at every fifteen minutes unto one hour

Study Arms (2)

Ketamine group (Group K)

EXPERIMENTAL

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.

Drug: Ketamine Hydrochloride

Saline group (Group S)

OTHER

Group S was given saline in 10 ml syringe

Drug: Ketamine Hydrochloride

Interventions

Ketamine HydrochlorideDRUG

Ketamine was given prior to wound closure.

Also known as: ketasol
Ketamine group (Group K)Saline group (Group S)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all ASA 1 and 2 patients undergoing Laparoscopic Cholecystectomy electively.

You may not qualify if:

  • Hepatic and renal disease and ASA 3 and 4 patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholelithiasis

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinded
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

March 17, 2021

First Posted

July 6, 2022

Study Start

January 17, 2013

Primary Completion

November 30, 2013

Study Completion

November 30, 2013

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share