Ketamine Effects as Preemptive Analgesia

September 21, 2023 updated by: Universitas Padjadjaran

Effects of Ketamine 0.5 Mg/Kgbw Administration as Preemptive Analgesia on Analgesia Duration and the Need for Fentanyl Following Hysterectomy Surgery

The goal of this randomized controlled trial is to compare the effect of preemptive ketamine administration to placebo administration in patients underwent hysterectomy surgery. The main questions it aims to answer are:

  1. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the duration of analgesia after hysterectomy surgery
  2. To determine the effect of ketamine at a dose of 0.5 mg/kgBW as preemptive analgesia on the need for fentanyl after hysterectomy surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • West Java
      • Bandung, West Java, Indonesia, 40161
        • Universitas Padjadjaran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 18-50 years.
  2. ASA I and II physical status (American Society of Anesthesiologists).

Exclusion Criteria:

  1. The patient is not willing to be included as a research subject
  2. The patient takes anti-pain medication before surgery
  3. History of allergies to the drugs to be used
  4. History of chronic pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Preemptive Ketamine
Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision
Drug: Ketamine
The intervention was prepared by the research team (anesthesia resident) in the form of ketamine which had been diluted to a dosage of 10 mg/cc, taken according to the required dose based on actual body weight then diluted with 0.9% NaCl to 10 cc. Then the two solutions were given to researchers without knowing the contents of the drugs that had been prepared by the resident who assisted in this research.
Placebo Comparator: Placebo
Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision
Other: Placebo
While the 0.9% NaCl solution was used as placebo was prepared in a 10 cc syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of postoperative analgesia
Time Frame: 24 hours post operative
Time interval from completion of hysterectomy until additional analgesic is needed, namely fentanyl 25 µg via PCA
24 hours post operative
Total need for post-operative analgesic rescue
Time Frame: 24 hours post operative
The total amount of rescue analgetic required by research subjects, during the 24 hours after surgery, was given via PCA
24 hours post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Padjadjaran

Investigators

  • Study Director: Iwan Fuadi, MD, Faculty of Medicine Universitas Padjadjaran Bandung
  • Study Director: Ardi Zulfariansyah, MD, Faculty of Medicine Universitas Padjadjaran Bandung
  • Principal Investigator: Jacklin E Mokoginta, MD, Faculty of Medicine Universitas Padjadjaran Bandung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2022

Primary Completion (Actual)

March 3, 2023

Study Completion (Actual)

March 3, 2023

Study Registration Dates

First Submitted

September 10, 2023

First Submitted That Met QC Criteria

September 10, 2023

First Posted (Actual)

September 15, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-202309.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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