Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection

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Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06607029
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Tiantan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Supratentorial Tumors

Additional Details

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, [email protected]) immediately after publication. The reasonable request should provide a formal protocol for database use that has been approved by the ethics institutions.

Arms & Interventions

Arms

Active Comparator: the opioid-based control group

Experimental: the opioid-free anaesthesia group

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.

Contact a Trial Team

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