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Brain Tumor Surgery and Postoperative Delirium

ConditionBrain Tumor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

at least 18 years old and less than 80 years old

receive brain tumor surgery with ASA II~III.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

140 Participants
are divided into 1 treatment group
Group A: Participant GroupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Perioperative
2

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.

Time frame
Perioperative
3

Assessment and Documentation of Delirium

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

Time frame
Perioperative
4

Assessment and Documentation of Delirium

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

Time frame
1 to 3 days post-surgery.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kaohsiung Medical University Chung-Ho Memorial Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: