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Recruiting NCT06607029

Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection

No phase Interventional Supratentorial Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: the opioid-based control group, the opioid-free anesthesia group.
Who it may be relevant to
Registry conditions: Supratentorial Tumors. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Opioid-free Anesthesia Protocol on the Quality of Recovery After Neurosurgical Supratentorial Tumor Resection: A Randomized, Controlled, Clinical Trial

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • the quality of recovery-15(QoR-15) score on the second day after surgery [Time frame: on the second day after surgery]
Secondary outcome measures (5)
  • The QoR-15 score on the 5th day after surgery [Time frame: on the 5th day after surgery]
  • The incidence of nausea and vomiting within 48 hours after surgery [Time frame: 48 hours after surgery]
  • The NRS pain score on the second and 5th days after surgery [Time frame: on the second and 5th days after surgery]
  • The sleep quality on the second and 5th days after surgery [Time frame: on the second and 5th days after surgery]
  • The incidence of chronic pain at 3 and 6 months after surgery [Time frame: at 3 and 6 months after surgery]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Publications

  • 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

Identifiers

NCT: NCT06607029 · OFA20240914

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗