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Ketamine Effects as Preemptive Analgesia

Primary Purpose

Pain, Postoperative

Status

Completed

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

Ketamine

Placebo

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring Ketamine, Preemptive Analgesia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Universitas Padjadjaran

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Preemptive Ketamine

Placebo

Arm Description

Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision

Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision

Outcomes

Primary Outcome Measures

Duration of postoperative analgesia

Time interval from completion of hysterectomy until additional analgesic is needed, namely fentanyl 25 µg via PCA

Total need for post-operative analgesic rescue

The total amount of rescue analgetic required by research subjects, during the 24 hours after surgery, was given via PCA

Secondary Outcome Measures

Full Information

NCT ID

NCT06040060

First Posted

September 10, 2023

Last Updated

September 21, 2023

Sponsor

Universitas Padjadjaran

1. Study Identification

Unique Protocol Identification Number

NCT06040060

Brief Title

Ketamine Effects as Preemptive Analgesia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

December 27, 2022 (Actual)

Primary Completion Date

March 3, 2023 (Actual)

Study Completion Date

March 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitas Padjadjaran

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

Keywords

Ketamine, Preemptive Analgesia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Preemptive Ketamine

Arm Type

Active Comparator

Arm Description

Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

While the 0.9% NaCl solution was used as placebo was prepared in a 10 cc syringe

Primary Outcome Measure Information:

Title

Duration of postoperative analgesia

Description

Time interval from completion of hysterectomy until additional analgesic is needed, namely fentanyl 25 µg via PCA

Time Frame

24 hours post operative

Title

Total need for post-operative analgesic rescue

Description

The total amount of rescue analgetic required by research subjects, during the 24 hours after surgery, was given via PCA

Time Frame

24 hours post operative

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Women only

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Iwan Fuadi, MD

Organizational Affiliation

Faculty of Medicine Universitas Padjadjaran Bandung

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ardi Zulfariansyah, MD

Organizational Affiliation

Faculty of Medicine Universitas Padjadjaran Bandung

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jacklin E Mokoginta, MD

Organizational Affiliation

Faculty of Medicine Universitas Padjadjaran Bandung

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitas Padjadjaran

City

Bandung

State/Province

West Java

ZIP/Postal Code

40161

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

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