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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Turgay Tuna, PhD | HUB-ULB Brussels, Belgium | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasme Hospital | Brussels | Brussels Capital | 1070 | Belgium |
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From the end of the study without an end date
All researchers with similar interests will be able to access the IPD and supporting information following a demand to the PI
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| 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 |
|
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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D017670 |
| Sodium Compounds |