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NCT06727435
Efficacy and Safety of Non-sedation Trial in Patients After Neurosurgical Craniotomy
NA trial testing non-sedation strategy in Craniotomy in 65 participants. Not yet recruiting.
30 June 2026
Quick facts
| Lead sponsor | Beijing Tiantan Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 65 |
| Start date | 1 January 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- non-sedation strategy — full drug profile →
Conditions studied
- Craniotomy — all drugs for Craniotomy →
- Neurosurgical Patients — all drugs for Neurosurgical Patients →
Sponsor
Beijing Tiantan Hospital
Who can join
Adults 18 to 85, any sex, with Craniotomy or Neurosurgical Patients. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Neurosurgical patients may be more vulnerable to stress caused by agitation after craniotomy, due to longer anesthesia duration, delayed extubation and pain and post-craniotomy frontal pneumocephalus and so on. Analgesia and sedation are important to the neurosurgical patients. However, there is little data to document the effects of protocolised analgesia and sedation on patients with neurological injury. The analgesia and sedation for neurosurgical patients is complex and difficult. The aim of the study is to explore the efficacy and safety of non-sedation strategies in patients admitted to ICU after neurosurgery craniotomy. This is a single-arm, single center, prospective clinical trial. Sixty- five adult patients whose Richmond Agitation-Sedation Scale (RASS) score greater than 1 point and intensive care unit (ICU) stay \> 24 hours after neurosurgical craniotomy will be enrolled. Patients eligible for this study will undergo non-sedation strategy, which continuous analgesia without sedation is performed with remifentanil. The remifentanil will be titrated (from 0.1µg/kg/min to 0.2ug/kg/min) every 10-15 minutes to achieve the goal for sedation (RASS score maintaining -2 to + 1). The patients in the non-sedation trial do not receive any sedatives but could receive bolus doses (2.5 or 5mg) of morphine for analgesia. The primary endpoints is the rate of successful sedation using non-sedation trials in the patients after neurosurgical craniotomy in ICU, defined as 1) RASS score -2 to +1. 2) No additional sedation required (any sedation medicine). The safety endpoints are the incidence of adverse events, including accidental removal of tubes (tracheal reintubation within 2 hours after extubation and reintubation of central venous catheterization (CVC) or gastric tube within 4h), significant agitation (RSAA score greater than 2), occurrences of need for CT or MRI brain scans.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06727435
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06727435 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Tiantan Hospital
- Last refreshed: 10 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06727435.
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