Supratentorial TumorsNCT06607029
Opioid-free Anesthesia Protocol for Neurosurgical Supratentorial Tumor Resection
A study testing the opioid-free anesthesia group in people with Supratentorial Tumors, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Supratentorial Tumors
- What is being tested?
- the opioid-free anesthesia group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Opioid-free Anesthesia Protocol on the Quality of Recovery After Neurosurgical Supratentorial Tumor Resection: A Randomized, Controlled, Clinical Trial
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.
Read the 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.
- Conditions
- Supratentorial Tumors
- Being tested
- the opioid-based control group, the opioid-free anesthesia group
- Medical subject headings
- Supratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the opioid-based control groupDrug
Intraoperative analgesia will be administered with conventional opioid drugs such as sufentanil and remifentanil.
the opioid-free anesthesia groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| the opioid-based control group | Active comparator | Not described Receives: Drug: the opioid-based control group |
| the opioid-free anaesthesia group | Experimental | Not described Receives: Drug: the opioid-free anesthesia group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: on the second day after surgery
Secondary outcomes (5)
The QoR-15 score on the 5th day after surgery
Measured: on the 5th day after surgery
The incidence of nausea and vomiting within 48 hours after surgery
Measured: 48 hours after surgery
The NRS pain score on the second and 5th days after surgery
Measured: on the second and 5th days after surgery
The sleep quality on the second and 5th days after surgery
Measured: on the second and 5th days after surgery
The incidence of chronic pain at 3 and 6 months after surgery
Measured: at 3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start21 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Supratentorial TumorsStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607029
- Sponsor's protocol ID
- OFA20240914
- Status last verified
- Mar 2025
- First submitted
- 15 Sep 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 40379317
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-free Anesthesia Protocol on the Quality of Recovery After Neurosurgical Supratentorial Tumor Resection: A Randomized, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT06607029
- Acronym / sponsor ID
- OFA20240914
- Conditions
- Supratentorial Tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the opioid-based control group | Active comparator | Drug: the opioid-based control group |
| the opioid-free anaesthesia group | Experimental | Drug: the opioid-free anesthesia group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the opioid-based control groupIntraoperative analgesia will be administered with conventional opioid drugs such as sufentanil and remifentanil. | Drug | the opioid-based control group |
| the opioid-free anesthesia groupThe patients will be administered with an opioid-free strategy during surgery. The investigator will use esketamine, dexmetopidine, and local anesthesia to control perioperative pain. | Drug | the opioid-free anaesthesia group |
Primary outcome
the quality of recovery-15(QoR-15) score on the second day after surgery
Time frame: 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).
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Derived from this study: PubMed 40379317Fu 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.
- Individual participant dataSharing planned: 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.
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Regional Anesthesia Morbidity, Supratentorial Brain Tumor
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Perioperative Multimodal Analgesia Protocol for Supratentorial Craniotomy
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Lonafarnib and Temozolomide in Treating Patients with Glioblastoma Multiforme That is Recurrent or Did Not Respond to Previous Treatment with Temozolomide
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the opioid-free anesthesia group in people with Supratentorial Tumors, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Han (010-59976660, ruquan.han@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the quality of recovery-15(QoR-15) score on the second day after surgery (time frame: on the second day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06607029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.