Dexmedetomidine Prevents Postoperative Delirium After Awake Craniotomies

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05195034

Collaborator

(none)

194

Enrollment

Location

Arms

Anticipated Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Dexmedetomidine Delirium Awake Craniotomy	Drug: Dexmedetomidine Drug: 0.9% saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Awake-DEX group The DEX group patients will be received dexmedetomidine intraoperatively.	Drug: Dexmedetomidine The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.5ug/kg/h intraoperatively.
Placebo Comparator: Placebo group The placebo group patients will be received 0.9% saline intraoperatively.	Drug: 0.9% saline The 0.9% saline is administered with the same volume at the same speed as the other group.

Arm

Intervention/Treatment

Active Comparator: Awake-DEX group

The DEX group patients will be received dexmedetomidine intraoperatively.

Drug: Dexmedetomidine

The 200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.5ug/kg/h intraoperatively.

Placebo Comparator: Placebo group

The placebo group patients will be received 0.9% saline intraoperatively.

Drug: 0.9% saline

The 0.9% saline is administered with the same volume at the same speed as the other group.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Preoperative severe cognitive impairment (Montreal Cognitive Assessment, MoCA< 18).
History of psychotropic drugs.
BMI≤18 or ≥30 Kg/mm2
Pregnant or lactating women.
History of traumatic brain injury or neurosurgery.
Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
Severe hepatic or renal dysfunction.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tian Tan Hospital, Capital Medical University	Beijing	Beijing	China	100160

Sponsors and Collaborators

Beijing Tiantan Hospital

Investigators

Principal Investigator: Yuming Peng, MD,Ph.D, Beijing Tian Tan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yuming Peng, Deputy chief of Department of Anesthesiology, Beijing Tiantan Hospital

ClinicalTrials.gov Identifier:

NCT05195034

Other Study ID Numbers:

2022-01-04

First Posted:

Jan 18, 2022

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Dexmedetomidine

Study Results

No Results Posted as of Apr 18, 2022