Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Supratentorial Tumors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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the opioid-based control group

Group Type ACTIVE_COMPARATOR

the opioid-based control group

Intervention Type DRUG

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

the opioid-free anaesthesia group

Group Type EXPERIMENTAL

the opioid-free anesthesia group

Intervention Type 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.

Interventions

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the opioid-based control group

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No