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New ICU strategy skips sedatives, uses only painkillers after brain surgery

NCT ID NCT06727435

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Not yet recruiting This study
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Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
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Expanded access (not trials)

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When the status isn't known

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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 85 years

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • Beijing Tiantan Hospital, South 4th Ring West Road 119, Fengtai District, Beijing 100070, China.

    Beijing, China

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