Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the opioid-based control group | Active Comparator |
| |
| the opioid-free anaesthesia group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the opioid-based control group | Drug | Intraoperative analgesia will be administered with conventional opioid drugs such as sufentanil and remifentanil. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the quality of recovery-15(QoR-15) score 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). | on the second day after surgery |
| Measure | Description | 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han | Contact | 010-59976660 | ruquan.han@ccmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40379317 | Derived | Fu Y, Zhou Y, Cui Y, Wu Y, Wang T, Li Y, Yu Y, Han R. Opioid-free anaesthesia and postoperative quality of recovery in patients undergoing supratentorial tumour resection: protocol for a randomised controlled trial. BMJ Open. 2025 May 15;15(5):e099864. doi: 10.1136/bmjopen-2025-099864. |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015173 | Supratentorial Neoplasms |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| the opioid-free anesthesia group | 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. |
|
| 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 |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |