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NCT Number: NCT05195034

Effect of Dexmedetomidine on Postoperative Delirium After Awake Craniotomies

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.

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Key information

Conditions

Dexmedetomidine Awake Craniotomy Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100160, China

Location status: Recruiting

Location contact

Yuming Peng

CONTACT

[email protected]

8610-59976658

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

0.9% saline

Drug

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuming Peng, MD,Ph.D

CONTACT

[email protected]

8610-59976658

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 18, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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