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Efficacy and Safety of Non-sedation Trial in Patients After Neurosurgical Craniotomy

NCT06727435 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-12-10

No results posted yet for this study

Summary

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.

Conditions

  • Craniotomy
  • Neurosurgical Patients

Interventions

DRUG

non-sedation strategy

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.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06727435 on ClinicalTrials.gov