An interventional study of the opioid-based control group and the opioid-free anesthesia group in Supratentorial Tumors, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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.
22 studies on the registry are indexed under Supratentorial Neoplasms; 3 are open to participants now.
This study's planned enrollment of 170 is above the median of 80 across 20 interventional studies indexed under Supratentorial Neoplasms.
Browse Supratentorial Neoplasms studies →Beijing Tiantan Hospital is the lead sponsor of 489 studies on the registry; 293 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: the opioid-based control group
Drug: the opioid-free anesthesia group
Intraoperative analgesia will be administered with conventional opioid drugs such as sufentanil and remifentanil.
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 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).
Time frame: on the second day after surgery
The QoR-15 score on the 5th day after surgery
Time frame: on the 5th day after surgery
The incidence of nausea and vomiting within 48 hours after surgery
Time frame: 48 hours after surgery
The NRS pain score on the second and 5th days after surgery
Time frame: on the second and 5th days after surgery
The sleep quality on the second and 5th days after surgery
Time frame: on the second and 5th days after surgery
The incidence of chronic pain at 3 and 6 months after surgery
Time frame: at 3 and 6 months after surgery
Plan to share: Yes — 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.
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Dec 2025, 14 months after the start.
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