Ketamine Effects as Preemptive Analgesia

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-27

Study Completion Date

2023-03-03

Brief Summary

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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

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Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Preemptive Ketamine

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No