NCT06607029

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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, [e-mail]) immediately after publication. The reasonable request should provide a formal protocol for database use that has been approved by the ethics institutions.

Conditions

• Supratentorial Tumors

Interventions

Type	Name	Description
DRUG	the opioid-based control group	Intraoperative analgesia will be administered with conventional opioid drugs such as sufentanil and remifentanil.
DRUG	the opioid-free anesthesia group	The patients will be administered with an opioid-free strategy during surgery. The investigator will use esketamine, dexmetopidine, and local anesthesia to control perioperative pain.

Timeline

• Start date: 2024-10-21
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2024-09-23
• Last updated: 2025-03-11

Locations

1 site across 1 country: China