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NCT Number: NCT07528651

Effects of S-ketamine on Perioperative Opioid Consumption

This study is a triple-blind randomized controlled trial conducted at a tertiary care hospital in Brussels. It investigates whether a single dose of S-ketamine can reduce opioid (morphine) consumption in the first 24 hours after elective laparoscopic gynecological surgery in relatively healthy adult patients (ASA 1-2). The goal is to assess S-ketamine's effectiveness within a standardized postoperative pain management protocol.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Analgesia Opioid Consumption, Postoperative Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, Brussels Capital, 1070, Belgium

About this study

This research focuses on improving postoperative pain management by evaluating the potential opioid-sparing effect of S-ketamine. While S-ketamine is known for its analgesic properties, its impact when used as a single dose alongside standardized analgesia protocols had not been previously studied in this specific surgical setting.

To address this, the investigators designed a triple-blind randomized controlled trial, meaning that the patients, healthcare providers, and outcome assessors were all unaware of treatment allocation. This design minimizes bias and strengthens the reliability of the findings.

The study was conducted at a tertiary care academic hospital in Brussels (Erasme Hospital), ensuring a controlled clinical environment with standardized procedures.

A total of 53 adult patients were included. All participants were classified as ASA physical status 1 or 2, indicating they were either healthy or had only mild systemic disease. These patients were scheduled for elective laparoscopic gynecological surgery, a procedure typically associated with moderate postoperative pain.

The primary objective of the study was to evaluate whether administering a single dose of S-ketamine could reduce postoperative opioid consumption, specifically measured as the total amount of morphine used during the first 24 hours after surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adult patients American Society of Anesthesiologists (ASA) physical status classification I or II
  • Scheduled for elective laparoscopic gynecological surgery

Exclusion criteria

  • Body mass index (BMI) > 30 kg/m²
  • Known allergy to any drugs used in the study
  • Chronic pain patients or regular use of analgesics
  • Pregnant or breastfeeding patients

Treatment and study plan

Esketamine at low dose

Drug

0.3 mg.kg-1 S-ketamine diluted in 50 ml of saline was administered intravenously for one hour at the beginning of the surgery, and the effect on the perioperative remifentanil consumption and the postoperative morphine consumption was studied

Saline (0.9% NaCl)

Drug

50 ml of saline was administered intravenously for one hour at the beginning of the surgery, and the effect on the perioperative remifentanil consumption and the postoperative morphine consumption was studied

Primary outcomes

  1. postoperative opioid consumption

    Time frame: from the end of the surgery up to 24 hours after surgery

    The primary outcome was postoperative opioid consumption, defined as morphine consumption in the first 24 hours after surgery

Secondary outcomes

  1. perioperative opioid consumption

    Time frame: from the induction of anesthesia until the end of the surgery

    perioperative opioid consumption, defined as remifentanil consumption per hour of surgery

  2. perioperative hypnotic consumption

    Time frame: from the induction of anesthesia until the end of the surgery

    perioperative hypnotic consumption, defined as propofol consumption per hour of surgery

  3. time of emergence from anesthesia

    Time frame: From cessation of anesthetic drug infusion until extubation, assessed at the end of surgery

    time of emergence from anesthesia, defined as the time between cessation of medication infusion and extubation

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Effects of S-ketamine on Perioperative Opioid Consumption in a Standardized Analgesia Administration Strategy. A Randomized Control Trial.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

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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