New ICU strategy skips sedatives, uses only painkillers after brain surgery
NCT ID NCT06727435
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study explores whether giving only pain medicine (remifentanil) without sedatives is safe and feasible for adults in the ICU after brain surgery. The goal is to avoid side effects of sedatives, like confusion or hiding signs of brain problems. Sixty-five participants will be monitored closely for 24 hours to see if this approach works without needing rescue sedatives.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria 1. Age 18-85 years; 2. Admission to the ICU after neurosurgical craniotomy; 3. Anticipated ICU stay greater than 24 hours according to the treating team at ICU admission or screening; 4. The Richmond Agitation-Sedation Scale (RASS) score ≥ +1, indicating restlessness or agitation requiring clinical management; 5. RASS, the Critical Care Pain Observation Tool (CPOT), and neurological status can be assessed reliably enough for protocol monitoring. Exclusion criteria 1. Need for deep sedation or therapeutic coma, including (partial pressure of oxygen(PaO2)/fraction of inspired oxygen(FiO2): PaO2/FiO2≤100 mmHg, neuromuscular blockade requiring unconsciousness, status epilepticus, mandatory immobility for surgical or procedural safety, severe traumatic brain injury and intracranial hypertension, therapeutic hypothermia and any clinical condition requiring RASS \< -2) \[15, 16\]; 2. Medullary lesion, brainstem condition, or other disorder associated with impaired respiratory drive in which opioid analgesia is judged unsafe by the treating physician \[17\]; 3. Inability to assess the RASS score or neurological status because of coma, severe aphasia, status epilepticus, severe cognitive dysfunction, schizophrenia, mania, or aother psychiatric or neurological condition that precludes reliable assessment.; 4. Use of sedatives or opioid analgesics ≥ 1 week before enrollment; 5. Expected ICU stay time less than or equal to 24 hours; 6. Delirium, alcohol withdrawal, active severe psychiatric illness, or ongoing antipsychotic therapy before enrolment; 7. Severe hepatic dysfunction (Child-Pugh grade C); 8. Renal failure requiring renal replacement therapy; 9. Need for major surgery during the ICU stay, except short bedside or minor procedures, such as lumbar puncture or ventricular drainage, etc.); 10. Known allergy or contraindication to remifentanil, morphine, midazolam, propofol, or other protocol medications; 11. Pregnancy or lactation; 12. Participation in another interventional clinical trial that could interfere with the study intervention or outcomes.; 13. Patient or legally authorized representative unwilling to participate; 14. Investigator judgment that inclusion is inappropriate because of a specific safety concern that is documented in the screening record.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital, South 4th Ring West Road 119, Fengtai District, Beijing 100070, China.
Beijing, China
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Other studies related to the condition(s) this trial covers.
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