Effects of S-ketamine on Perioperative Opioid Consumption

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Pain Management; Opioid Analgesia; Opioid Consumption, Postoperative
• Intervention / Treatment: Drug: Esketamine at low dose; Drug: Saline (0.9% NaCl)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1070
      • Erasme Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stdudy group; Once the intravenous line was secured, the study syringe was connected, and the contents (0.3 mg · kg-1 S-ketamine diluted in 50 ml of saline) were administered intravenously for one hour.	Drug: Esketamine at low dose; 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; Drug: Saline (0.9% NaCl); 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
Placebo Comparator: control group; Once the intravenous line was secured, the study syringe was connected, and the content (50 ml of saline) was administered intravenously for one hour.	Drug: Saline (0.9% NaCl); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative opioid consumption	The primary outcome was postoperative opioid consumption, defined as morphine consumption in the first 24 hours after surgery	from the end of the surgery up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative opioid consumption	perioperative opioid consumption, defined as remifentanil consumption per hour of surgery	from the induction of anesthesia until the end of the surgery
perioperative hypnotic consumption	perioperative hypnotic consumption, defined as propofol consumption per hour of surgery	from the induction of anesthesia until the end of the surgery
time of emergence from anesthesia	time of emergence from anesthesia, defined as the time between cessation of medication infusion and extubation	From cessation of anesthetic drug infusion until extubation, assessed at the end of surgery

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Study Chair: Turgay Tuna, PhD, HUB-ULB Brussels, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): June 21, 2022
• Study Completion (Actual): June 21, 2022

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: personalized analgesia; co-analgesics; personalized pain management; antinociception monitoring
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Agnosia; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: P2020/667 B4062020000296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: From the end of the study without an end date
• IPD Sharing Access Criteria: All researchers with similar interests will be able to access the IPD and supporting information following a demand to the PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No