Brain Tumor Surgery and Postoperative Delirium

NCT06863064 | Not Yet Recruiting

• 1 other identifier: KMUHIRB-F(I)-20240297
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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.

Conditions

Brain Tumor

Keywords

brain tumor; postoperative delirium

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (1)

Participant Group

EXPERIMENTAL

brain tumor postoperative

Drug: Dexmedetomidine; Drug: Normal Saline

Interventions

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.

Participant Group

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.

Participant Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Brain Neoplasms; Emergence Delirium

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Central Study Contacts

Zhi-Fu Wu

CONTACT

886+75978215; aneswu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: March 7, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 7, 2025

Record last verified: 2025-03

Locations

TW (1)