Clinical trial · Interventional
Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection
Opioid-free Anesthesia Protocol on the Quality of Recovery After Neurosurgical Supratentorial Tumor Resection: A Randomized, Controlled, Clinical Trial
- 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)
Opioids have many side effects, such as constipation, urinary retention, itchy skin, respiratory depression, and postoperative nausea and vomiting. These side effects can lead to delayed recovery, longer hospital stays, and increased health care costs. Opioid-free anesthesia is the combination of anti-nociceptive drugs to block the different pathways involved in the transmission of nociceptive information, control pain, avoid opioid-related adverse reactions, and promote patient recovery. At present, opioid-free anesthesia is not widely used in craniocerebral surgery in neurosurgery, and the relevant clinical data are extensive. Therefore, the investigators urgently need to conduct a randomized controlled study to provide clinical evidence for the efficacy and safety of opioid-free anesthesia in neurosurgical patients.
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 |
|---|---|---|---|
| Supratentorial Tumors | Supratentorial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| the opioid-based control group | Drug | — | UNRESOLVED |
| the opioid-free anesthesia group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- the opioid-based control group
- interventionNames
- Drug: the opioid-based control group
- type
- EXPERIMENTAL
- label
- the opioid-free anaesthesia group
- interventionNames
- Drug: the opioid-free anesthesia group
Primary outcomes (1)
- measure
- the quality of recovery-15(QoR-15) score on the second day after surgery
- timeFrame
- on the second day after surgery
- description
- Quality of Recovery-15(QoR-15) score, as a tool to evaluate recovery quality during perioperative period. The QoR-15 scale was used to assess patients' postoperative recovery. Each item is scored on a 10-point scale, from 0 (worst recovery) to 150 (best recovery).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled to undergo craniotomy for supratentorial tumors with general anesthesia; * 18 years≤age≤65 years; * American Society of Anesthesiologists (ASA) physical status of I to III; * Signed informed consent. Exclusion Criteria: * Patients with a body mass index (BMI)≥35 kg/m2; * Patients with severe hepatic and renal insufficiency; * Patients with cognitive dysfunction, aphasia and other states that do not cooperate with the assessment; * Preoperative magnetic resonance imaging of the head showed midline displacement \>5 mm; * Patients undergoing electrophysiological monitoring during surgery; * Pregnant or lactating patients.
References
Publications (1)
- DERIVEDFu Y, Zhou Y, Cui Y, Wu Y, Wang T, Li Y, Yu Y, Han R. Opioid-free anaesthesia and postoperative quality of recovery in patients undergoing supratentorial tumour resection: protocol for a randomised controlled trial. BMJ Open. 2025 May 15;15(5):e099864. doi: 10.1136/bmjopen-2025-099864. PMID 40379317