Ketamine Effects as Preemptive Analgesia

Sponsor

Universitas Padjadjaran (Other)

Overall Status

Completed

CT.gov ID

NCT06040060

Collaborator

(none)

Enrollment

Location

Arms

2.2

Actual Duration (Months)

18.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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:

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
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

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Ketamine Other: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 27, 2022

Actual Primary Completion Date :

Mar 3, 2023

Actual Study Completion Date :

Mar 3, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitas Padjadjaran	Bandung	West Java	Indonesia	40161

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitas Padjadjaran

ClinicalTrials.gov Identifier:

NCT06040060

Other Study ID Numbers:

AN-202309.02

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 22, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universitas Padjadjaran

Ketamine

Preemptive Analgesia

Additional relevant MeSH terms:

Pain, Postoperative

Ketamine

Study Results

No Results Posted as of Sep 22, 2023