Clinical trial NCT06607029: Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection
Official title: Opioid-free Anesthesia Protocol on the Quality of Recovery After Neurosurgical Supratentorial Tumor Resection: A Randomized, Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supratentorial Tumors
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: the quality of recovery-15(QoR-15) score on the second day after surgery
timeFrame: on the second day after surgery
Secondary outcomes:
measure: The QoR-15 score on the 5th day after surgery
timeFrame: on the 5th day after surgery
measure: The incidence of nausea and vomiting within 48 hours after surgery
timeFrame: 48 hours after surgery
measure: The NRS pain score on the second and 5th days after surgery
timeFrame: on the second and 5th days after surgery
measure: The sleep quality on the second and 5th days after surgery
timeFrame: on the second and 5th days after surgery
measure: The incidence of chronic pain at 3 and 6 months after surgery
timeFrame: at 3 and 6 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References: