Brain Tumor Surgery and Postoperative Delirium

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Brain Tumor
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhi-Fu Wu; Phone Number: 886+75978215; Email: aneswu@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
    • Contact: Zhi-Fu Wu; Phone Number: +88675978215

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Participant Group; brain tumor postoperative

Drug: Dexmedetomidine; 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.; Drug: Normal Saline; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment and Documentation of Delirium	Confusion assessment method in intensive care unit using questionnaire(CAM-ICU), The evaluation method is "yes" or "no," with "no" being the best.	Perioperative
Assessment and Documentation of Delirium	3-minute diagnostic interview with confusion assessment method (3D-CAM), The evaluation method is "yes" or "no," with "no" being the best.	Perioperative
Assessment and Documentation of Delirium	Richmond Agitation-Sedation Scale (RASS) ,The score ranges from +4 to -5, with +4 being the best.	Perioperative
Assessment and Documentation of Delirium	Numerical Rating Scale (NRS) ,The score ranges from 0 to 10, with 0 being the best.	1 to 3 days post-surgery.
Assessment and Documentation of Delirium	Richards Campbell Sleep Questionnaire (RCSQ) ,The score ranges from 0 to 100, with 100 being the best.	1 to 3 days post-surgery.

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: March 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: brain tumor; postoperative delirium
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Nervous System Neoplasms; Central Nervous System Neoplasms; Emergence Delirium; Delirium; Brain Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: KMUHIRB-F(I)-20240297

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No