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NCT Number: NCT06863064

Brain Tumor Surgery and Postoperative Delirium

1. To explore whether the combined administration of dexmedetomidine during and after surgery in patients undergoing brain tumor resection is an effective and safe modality to prevent postoperative delirium and improve sleep quality than giving it alone after surgery. 2. To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can reduce postoperative acute pain and prevent chronic pain. 3. To explore whether intraoperative and postoperative administration of dexmedetomidine to patients undergoing brain tumor surgery can provide stable anesthesia depth, hemodynamics and reduce the dose of anesthetics, thereby accelerating patient recovery.

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Key information

Conditions

Brain Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Confusion Delirium Emergence Delirium Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location contact

Zhi-Fu Wu

CONTACT

+88675978215

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • at least 18 years old and less than 80 years old
  • receive brain tumor surgery with ASA II~III.

Exclusion criteria

  • under the age of 18 or over 80
  • consciousness unclear
  • those who have not signed a consent form
  • those with high anesthesia risk ASA IV or higher

Treatment and study plan

Dexmedetomidine

Drug

During the surgery, target-controlled infusion (TCI) pumps were used, employing the Dyck model for continuous infusion of propofol, with the target plasma concentration maintained at 0.2 ng/ml. Postoperatively, propofol was infused at a rate of 0.2-0.4 mcg/kg/hr according to the intensive care unit's protocol, until the patient had the endotracheal tube removed.

normal saline

Drug

During the surgery, equal volumes of saline were injected. After the surgery, the patient was transferred to the intensive care unit, where propofol was continuously infused at a rate of 0.2-0.4 mcg/kg/hr according to the ICU protocol, until the endotracheal tube was removed.

Primary outcomes

  1. Assessment and Documentation of Delirium

    Time frame: Perioperative

    Confusion assessment method in intensive care unit using questionnaire(CAM-ICU), The evaluation method is "yes" or "no," with "no" being the best.

  2. Assessment and Documentation of Delirium

    Time frame: Perioperative

    3-minute diagnostic interview with confusion assessment method (3D-CAM), The evaluation method is "yes" or "no," with "no" being the best.

  3. Assessment and Documentation of Delirium

    Time frame: Perioperative

    Richmond Agitation-Sedation Scale (RASS) ,The score ranges from +4 to -5, with +4 being the best.

  4. Assessment and Documentation of Delirium

    Time frame: 1 to 3 days post-surgery.

    Numerical Rating Scale (NRS) ,The score ranges from 0 to 10, with 0 being the best.

  5. Assessment and Documentation of Delirium

    Time frame: 1 to 3 days post-surgery.

    Richards Campbell Sleep Questionnaire (RCSQ) ,The score ranges from 0 to 100, with 100 being the best.

Study contacts

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

Zhi-Fu Wu

CONTACT

[email protected]

886+75978215

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

Exploring the Effects of Perioperative Dexmedetomidine on the Incidence of Postoperative Delirium, Acute and Chronic Pain, and Sleep Quality in Patients Undergoing Brain Tumor Surgery

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
Mar 7, 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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