Ketamine Effects as Preemptive Analgesia

NCT06040060 | Completed Phase 2 DMC

• 1 other identifier: AN-202309.02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 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

Conditions

Pain, Postoperative

Keywords

Ketamine; Preemptive Analgesia

Outcome Measures

Primary Outcomes (2)

• Duration of postoperative analgesia

  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

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

  24 hours post operative

Study Arms (2)

Preemptive Ketamine

ACTIVE COMPARATOR

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

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Ketamine 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.

Preemptive Ketamine

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Women only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Universitas Padjadjaran

Bandung, West Java, 40161, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Iwan Fuadi, MD

  Faculty of Medicine Universitas Padjadjaran Bandung

  STUDY DIRECTOR

• Ardi Zulfariansyah, MD

  Faculty of Medicine Universitas Padjadjaran Bandung

  STUDY DIRECTOR

• Jacklin E Mokoginta, MD

  Faculty of Medicine Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: December 27, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)