Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection

Last updated: March 8, 2025
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Cancer

Treatment

the opioid-free anesthesia group

the opioid-based control group

Clinical Study ID

NCT06607029
OFA20240914
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 cooperatewith the assessment;

  • Preoperative magnetic resonance imaging of the head showed midline displacement >5mm;

  • Patients undergoing electrophysiological monitoring during surgery;

  • Pregnant or lactating patients.

Study Design

Total Participants: 170
Treatment Group(s): 2
Primary Treatment: the opioid-free anesthesia group
Phase:
Study Start date:
October 21, 2024
Estimated Completion Date:
March 31, 2026

Study 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.

Connect with a study center

  • Beijing Tiantan Hospital

    Beijing,
    China

    Active - Recruiting

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