Clinical trial · Interventional
Effect of Intravenous S-ketamine on Opioid Consumption
Effect of Intravenous S-ketamine on Opioid Consumption and Postoperative Pain in Patients Undergoing Breast Cancer Surgery：a Multicenter, Randomised, Control Trial
NCT05060068CI-TRIAL-00079526completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Female patients with an American Society of Anesthesia (ASA) physical status I-II, scheduled for elective breast cancer surgery will be included in the study. Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The primary outcome is the consumption of sufentanil during the surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Surgery | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| S-ketamine (high dose) | Drug | — | UNRESOLVED |
| S-ketamine (low dose) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- Patients in the placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline until 30 min prior to the end of the surgery.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Low-dose ketamine group
- description
- Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 2 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
- interventionNames
- Drug: S-ketamine (low dose)
- type
- EXPERIMENTAL
- label
- High-dose ketamine group
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. Female patients with an American Society of Anesthesia (ASA) physical status I-II 2. Scheduled for elective breast cancer surgery Exclusion Criteria: 1. Patients unable to understand the study procedure or unable to give informed consent 2. with concurrent analgesic or sedative medication, 3. with history of chronic pain 4. with history of psychiatric disorders 5. with history of alcohol or drug abuse 6. with an allergy to the study medication 7. who are pregnant or breast feeding 8. with a BMI \>30 and \<18 kg/m\^2 9. with severe cardiac, pulmonary, hepatic or renal dysfunction 10. with intracranial hypertension
References
Publications (2)
- BACKGROUNDBrinck ECV, Maisniemi K, Kankare J, Tielinen L, Tarkkila P, Kontinen VK. Analgesic Effect of Intraoperative Intravenous S-Ketamine in Opioid-Naive Patients After Major Lumbar Fusion Surgery Is Temporary and Not Dose-Dependent: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Anesth Analg. 2021 Jan;132(1):69-79. doi: 10.1213/ANE.0000000000004729. PMID 32167978
- BACKGROUNDHamp T, Baron-Stefaniak J, Krammel M, Reiter B, Langauer A, Stimpfl T, Plochl W. Effect of intravenous S-ketamine on the MAC of sevoflurane: a randomised, placebo-controlled, double-blinded clinical trial. Br J Anaesth. 2018 Dec;121(6):1242-1248. doi: 10.1016/j.bja.2018.08.023. Epub 2018 Oct 15. PMID 30442251