Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection

Not Applicable

Recruiting

• Conditions: Supratentorial Tumors
• Interventions: Drug: the opioid-based control group; Drug: the opioid-free anesthesia group

• Registration Number: NCT06607029
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Data sharing plan: The deidentified participant data reported in this study could be made available to researchers upon approval by the corresponding author (Dr. Ruquan Han, ruquan.han@ccmu.edu.cn) immediately after publication. The reasonable request should provide a formal protocol for database use that has been approved by the ethics institutions.

Study Timeline

• Study First Submitted: 2024-09-15
• Study First Submitted QC: 2024-09-18
• Study First Posted: 2024-09-23
• Study Start: 2024-10-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-08
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the opioid-based control group	the opioid-based control group	-
the opioid-free anaesthesia group	the opioid-free anesthesia group	-

Primary Outcome Measures

Name	Time	Method
the quality of recovery-15(QoR-15) score on the second day after surgery	on the second day after surgery	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).

Secondary Outcome Measures

Name	Time	Method
The QoR-15 score on the 5th day after surgery	on the 5th day after surgery
The incidence of nausea and vomiting within 48 hours after surgery	48 hours after surgery
The NRS pain score on the second and 5th days after surgery	on the second and 5th days after surgery
The sleep quality on the second and 5th days after surgery	on the second and 5th days after surgery
The incidence of chronic pain at 3 and 6 months after surgery	at 3 and 6 months after surgery

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China