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Ketamine for Postoperative Pain in Bariatric Surgery

NCT ID: NCT03389022

Last Updated: 2021-11-22

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-22

Study Completion Date

2023-06-06

Brief Summary

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The aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery. Ketamine is an old general anaesthetic. Low doses of it might be used as a adjunct in postoperative analgesia.The investigators expect that the low-dose ketamine reduces postoperative pain after bariatric surgeries.

Detailed Description

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Effective postoperative pain management enhances early postoperative rehabilitation and may improve outcomes of surgical treatment. New analgetic medications and combinations of these are sought for optimal analgesia with lowest possible incidence of side effects. One of the method of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine. To our knowledge, the role of ketamine in the treatment of postoperative pain after bariatric surgeries is poorly researched. The investigators hypothesize that ketamine, acting through the N-methyl-D-aspartate receptor (NMDA) and opioid receptors, provides favourable conditions for adequate post-operative pain management.

Conditions

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Pain, Postoperative Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment1

0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.

Treatment2

0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection of ketamine given for bariatric patients in the operating room.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.

Treatment3

0,15 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.

Control

The same amount of intravenous single pre-incisional injection of saline for bariatric patients in the operating room.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Intravenous injection given pre-incisional in the operating room.

Treatment4

0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.

Interventions

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Ketamine

0,15 mg/kg pre-incisional single bolus dose of ketamine in the operating room.

Intervention Type DRUG

Saline

Intravenous injection given pre-incisional in the operating room.

Intervention Type DRUG

Ketamine

0,3 mg/kg pre-incisional single bolus dose of ketamine in the operating room.

Intervention Type DRUG

Ketamine

0,15 mg/kg pre-incisional single bolus dose of ketamine, followed by continuous infusion of 1 mg/kg in the operating room.

Intervention Type DRUG

Ketamine

0,3 mg/kg (LBM) of intravenous pre-incisional single bolus injection, followed by continuous infusion of 1mg/kg ketamine given for bariatric patients in the operating room.

Intervention Type DRUG

Other Intervention Names

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Ketamine hydrochloride Sodium chloride Ketamine hydrochloride Ketamine hydrochloride Ketamine hydrochloride

Eligibility Criteria

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Inclusion Criteria

* II or III The American Society of Anesthesiologists (ASA) physical status
* age \> 18 years
* bariatric surgery with general remifentanil anesthesia

Exclusion Criteria

* anamnesis of using opioids for the treatment of chronic pain
* opioid dependence
* younger than 18 years
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Greta Kasputytė

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aurika Karbonskienė, MDPhDAssProf

Role: STUDY_CHAIR

Lithuanian University of Health Sciences

Other Identifiers

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BEC-MF-713

Identifier Type: -

Identifier Source: org_study_id