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Completed

NCT Number: NCT06040060

Ketamine Effects as Preemptive Analgesia

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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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Universitas Padjadjaran

Bandung, West Java, 40161, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Other

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

Primary outcomes

  1. Duration of postoperative analgesia

    Time frame: 24 hours post operative

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

  2. Total need for post-operative analgesic rescue

    Time frame: 24 hours post operative

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

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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