Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

Delirium Clinical Trial

Official title:

Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Awake Craniotomies: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05195034
• Other study ID #: 2022-01-04
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2022
• Source: Beijing Tiantan Hospital
• Contact: Yuming Peng, MD,Ph.D
• Phone: 8610-59976658
• Email: florapym766[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 31, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Dexmedetomidine

Intervention

Drug:
• Dexmedetomidine
The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with continuous infusion at a rate of 0.2 µg/kg/hour until the end of dural closure.
• 0.9% saline
The 0.9% saline is administered with the same volume at the same speed as the other group.

Locations

Country	Name	City	State
China	Beijing Tian Tan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative delirium.	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.	postoperative 5 day.