Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

February 12, 2025 updated by: Yuming Peng, Beijing Tiantan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100160
        • Recruiting
        • Beijing Tian Tan Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 continuous infusion at a rate of 0.2 µg/kg/hour until the end of dural closure.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative delirium.
Time Frame: 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.
postoperative 5 day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2022

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 4, 2022

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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