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Trial Title:
Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection
NCT ID:
NCT06607029
Condition:
Supratentorial Tumors
Conditions: Official terms:
Supratentorial Neoplasms
Analgesics, Opioid
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
the opioid-based control group
Description:
Intraoperative analgesia will be administered with conventional opioid drugs such as
sufentanil and remifentanil.
Arm group label:
the opioid-based control group
Intervention type:
Drug
Intervention name:
the opioid-free anesthesia group
Description:
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.
Arm group label:
the opioid-free anaesthesia group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tiantan Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Start date:
October 21, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Beijing Tiantan Hospital
Agency class:
Other
Source:
Beijing Tiantan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06607029
