Ketamine Effects as Preemptive Analgesia

Phase 2

Completed

• Conditions: Pain, Postoperative
• Interventions: Other: Placebo; Drug: Ketamine

• Registration Number: NCT06040060
• Lead Sponsor: Universitas Padjadjaran

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:

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-27
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Status Verified: 2023-09
• Study First Submitted: 2023-09-10
• Study First Submitted QC: 2023-09-10
• Study First Posted: 2023-09-15
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administration of 10 mL NaCl 0,9% intravenously, given 10 minutes prior to incision
Preemptive Ketamine	Ketamine	Preemptive administration of Ketamine 0.5 mg/kgBB intravenously, given 10 minutes prior to incision

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Universitas Padjadjaran; 🇮🇩 Bandung, West Java, Indonesia