Brain Tumor Surgery and Postoperative Delirium

March 4, 2025 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

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

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

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

  • 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

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

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
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.
Perioperative
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.
Perioperative
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.
Perioperative
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.
1 to 3 days post-surgery.
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.
1 to 3 days post-surgery.

Collaborators and Investigators

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

Sponsor

Kaohsiung Medical University Chung-Ho Memorial 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 (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

Additional Relevant MeSH Terms

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

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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