Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection

NCT06607029 | Recruiting

• 1 other identifier: OFA20240914
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Supratentorial Tumors

Outcome Measures

Primary Outcomes (1)

• the quality of recovery-15(QoR-15) score 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).

  on the second day after surgery

Secondary Outcomes (5)

• 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

Study Arms (2)

the opioid-based control group

ACTIVE COMPARATOR

Drug: the opioid-based control group

the opioid-free anaesthesia group

EXPERIMENTAL

Drug: the opioid-free anesthesia group

Interventions

the opioid-based control group DRUG

Intraoperative analgesia will be administered with conventional opioid drugs such as sufentanil and remifentanil.

the opioid-based control group

the opioid-free anesthesia group DRUG

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.

the opioid-free anaesthesia group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo craniotomy for supratentorial tumors with general anesthesia;
• years≤age≤65 years;
• American Society of Anesthesiologists (ASA) physical status of I to III;
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Fu 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 DERIVED

MeSH Terms

Conditions

Supratentorial Neoplasms

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Han

CONTACT

010-59976660; ruquan.han@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology

Study Record Dates

• First Submitted: September 15, 2024
• First Posted: September 23, 2024
• Study Start: October 21, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)