Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

NCT05195034 | Recruiting

• 1 other identifier: 2022-01-04
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Delirium; Awake Craniotomy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

DEX group

ACTIVE COMPARATOR

The DEX group patients will be received dexmedetomidine intraoperatively.

Drug: Dexmedetomidine

Placebo group

PLACEBO COMPARATOR

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

Drug: 0.9% saline

Interventions

Dexmedetomidine DRUG

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.

DEX group

0.9% saline DRUG

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

Placebo group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Preoperative moderate and severe cognitive impairment (Montreal Cognitive Assessment, MoCA\< 18).
• Preoperative psychotropic medication within one year.
• BMI≤18 or ≥30 Kg/ m2
• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100160, China

RECRUITING

Related Publications (1)

• Li M, Liu M, Cui Q, Zeng M, Li S, Zhang L, Peng Y. Effect of dexmedetomidine on postoperative delirium in patients undergoing awake craniotomies: study protocol of a randomized controlled trial. Trials. 2023 Sep 25;24(1):607. doi: 10.1186/s13063-023-07632-2.

  PMID: 37743486 DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yuming Peng, MD,Ph.D

  Beijing Tian Tan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuming Peng, MD,Ph.D

CONTACT

8610-59976658; florapym766@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 18, 2022
• Study Start: March 31, 2022
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)