Supratentorial Tumors
Conditions
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.
Interventions
DRUGthe opioid-based control group
Intraoperative analgesia will be administered with conventional opioid drugs such as sufentanil and remifentanil.
DRUGthe 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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the quality of recovery-15(QoR-15) score on the second day after surgery | on the second day after surgery | Quality of Recovery-15(QoR-15) score, as a tool to evaluate recovery quality during perioperative period. The QoR-15 scale was used to assess patients' postoperative recovery. Each item is scored on a 10-point scale, from 0 (worst recovery) to 150 (best recovery). |
Secondary
| Measure | Time frame |
|---|---|
| The QoR-15 score on the 5th day after surgery | on the 5th day after surgery |
| The incidence of nausea and vomiting within 48 hours after surgery | 48 hours after surgery |
| The NRS pain score on the second and 5th days after surgery | on the second and 5th days after surgery |
| The sleep quality on the second and 5th days after surgery | on the second and 5th days after surgery |
| The incidence of chronic pain at 3 and 6 months after surgery | at 3 and 6 months after surgery |
Countries
China
Contacts
Primary ContactHan
Outcome results
None listed