Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

Not Applicable

Recruiting

• Conditions: Dexmedetomidine; Awake Craniotomy; Delirium
• Interventions: Drug: 0.9% saline; Drug: Dexmedetomidine

• Registration Number: NCT05195034
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

Postoperative delirium (POD) is a common complication, and the incidence of POD ranges from 10% to 60%. Previous studies suggested that frontal approach and tumor located at the temporal lobe were independent risk factors for POD after supratentorial tumor resections. Therefore, patients undergoing awake craniotomies are high-risk populations for POD. A lot of trials show that dexmedetomidine might help to reduce the incidence of delirium in patients undergoing non-cardiac surgery. However, the impact of dexmedetomidine (DEX) on POD for patients undergoing awake craniotomies remains unclear. The purpose of this study was to investigate the effect of DEX on POD in patients undergoing awake craniotomies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-18
• Study Start: 2022-03-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Patients undergoing selective awake craniotomies.
• Age ≥18 years.
• Obtain written informed consent.

Exclusion Criteria

• 1.Preoperative moderate and severe cognitive impairment (Montreal Cognitive Assessment, MoCA< 18).
• 2.Preoperative psychotropic medication within one year.
• 3.BMI≤18 or ≥30 Kg/ m2
• 4.Pregnant or lactating women.
• 5.History of traumatic brain injury or neurosurgery.
• 6.Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
• 7.Severe hepatic or renal dysfunction.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	0.9% saline	The placebo group patients will be received 0.9% saline intraoperatively.
DEX group	Dexmedetomidine	The DEX group patients will be received dexmedetomidine intraoperatively.

Primary Outcome Measures

Name	Time	Method
The incidence of postoperative delirium.	postoperative 5 day.	postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable.

Trial Locations

Locations (1)

Beijing Tian Tan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China