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

NCT06727435 | Not Yet Recruiting DMC

• 1 other identifier: non-sedation trials
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

analgesia; sedation; craniotomy; neurosurgical patients

Outcome Measures

Primary Outcomes (1)

• The primary endpoints is the efficacy and safety of non-sedation trial

  The primary endpoints is the rate of successful sedation using non-sedation trials in the patients after neurosurgical craniotomy in ICU.

  from enrollment to the discharge of ICU, 28 days or death, whichever came first

Study Arms (1)

non-sedation strategy

EXPERIMENTAL

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.

Drug: non-sedation strategy

Interventions

non-sedation strategy DRUG

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.

non-sedation strategy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-85 years old, with ICU stay \> 24 hours;
• The Richmond Agitation-Sedation Scale (RASS) score is greater than 1 point (Restless: anxious or apprehensive but movements not aggressive or vigorous);
• Patients after neurosurgical craniotomy.

You may not qualify if:

• Patients who need deep sedation (PaO2/FiO2≤100 mmHg, loss of consciousness during muscle relaxant therapy, status epilepticus, absolute braking for surgical or surgical conditions, severe traumatic brain injury and cranial hypertension, therapeutic hypothermia and other clinical assessments need to maintain RASS \<-2);
• Patients who may damage the medullary bullongans which contents respiratory center and avoid the application of analgesic drugs;
• Patients who cannot assess the RASS score due to various reasons, such as aphasia, history of mental system (schizophrenia, mania, confusion, history of cognitive dysfunction), generalized seizure status, coma patients, postoperative aphasia, etc.;
• Patients who use sedatives or opioid analgesics ≥ 1 week before enrollment;
• The expected ICU stay time less than 24 hours;
• The patients with delirium, alcohol withdrawal symptoms or mental illness or the use of antipsychotic drugs;
• Severe abnormal liver function (Child-Pugh grade C);
• Renal insufficiency requiring renal replacement therapy;
• Surgical treatment is required during the ICU (except for short surgery, such as lumbar puncture, ventricular drainage, etc.);
• Study drug allergy or other contraindications;
• women during pregnancy or lactation;
• Who was selected in other RCT tests;
• The patient himself or the legally authorized person is not willing to participate in the trial;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Guangzhi Shi, Professor

CONTACT

86-13601110669; shiguangzhi@bjtth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of critical care unit

Model Details: single-arm, single center, prospective clinical trial

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)