Opioid-free anesthesia for brain tumor surgery
Opioid-free Anesthesia Protocol on the Quality of Recovery After Neurosurgical Supratentorial Tumor Resection: A Randomized, Controlled, Clinical Trial
This study tests whether using opioid-free anesthesia during brain tumor surgery can help patients manage pain without the side effects of opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06607029 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of opioid-free anesthesia in patients undergoing craniotomy for supratentorial tumors. The approach combines various anti-nociceptive drugs to manage pain without the side effects associated with opioids, such as respiratory depression and postoperative nausea. By conducting a randomized controlled trial, the researchers aim to gather clinical evidence on the efficacy and safety of this anesthesia method in neurosurgical patients. The study will compare outcomes between an opioid-based control group and an opioid-free anesthesia group.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 scheduled for craniotomy for supratentorial tumors with an ASA physical status of I to III.
Not a fit: Patients with severe obesity, significant hepatic or renal issues, or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery times and reduced hospital stays for patients undergoing brain surgery.
How similar studies have performed: While opioid-free anesthesia is not widely used in neurosurgery, there is a growing body of clinical data supporting its efficacy in other surgical fields.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing
- Beijing Tiantan Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Han
- Email: ruquan.han@ccmu.edu.cn
- Phone: 010-59976660
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.