Effects of S-ketamine on Perioperative Opioid Consumption

NCT07528651 | Completed

• 1 other identifier: P2020/667 B4062020000296
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management; Postoperative Pain; Opioid Consumption, Postoperative; Opioid Analgesia

Keywords

personalized analgesia; co-analgesics; personalized pain management; antinociception monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• perioperative opioid consumption

  from the induction of anesthesia until the end of the surgery

• perioperative hypnotic consumption

  from the induction of anesthesia until the end of the surgery

• time of emergence from anesthesia

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

Study Arms (2)

Stdudy group

EXPERIMENTAL

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; Drug: Saline (0.9% NaCl)

control group

PLACEBO COMPARATOR

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)

Interventions

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

Stdudy group

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

Stdudy group; control group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Erasme Hospital

Brussels, Brussels Capital, 1070, Belgium

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Turgay Tuna, PhD

  HUB-ULB Brussels, Belgium

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 14, 2026
• Study Start: June 7, 2021
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From the end of the study without an end date
• Access Criteria: All researchers with similar interests will be able to access the IPD and supporting information following a demand to the PI

Locations

BE (1)