Dexmedetomidine for Prevention of Postoperative Delirium After Intracranial Operation for Brain Tumor (DEPOD)

January 27, 2021 updated by: Jian-Xin Zhou, Capital Medical University

Dexmedetomidine for Prevention of Postoperative Delirium in Patients After Intracranial Operation for Brain Tumor: a Multicenter Randomized Controlled Trial

Postoperative delirium is common after major surgery, and is associated with adverse outcomes. Systematic reviews and meta-analyses of randomized controlled trials have shown that perioperative administration of dexmedetomidine may decrease the incidence of postoperative delirium in patients after either cardiac or non-cardiac surgery. However, neurosurgical patients are often excluded in clinical trials of postoperative delirium.

In this prospective, multicenter, randomized, double-blinded, and placebo-controlled trial with two parallel arms, ICU admitted adult patients after intracranial operation for brain tumor will be enrolled. Low-dose dexmedetomidine will be applied during the early postoperative phase. The investigators aim to evaluate the efficacy and safety of low-dose dexmedetomidine for prevention of postoperative delirium in this patient population. The primary hypothesis is that, compared to the placebo group, the prophylactic use of low-dose dexmedetomidine can decrease the incidence of postoperative delirium without significant adverse events in patients after intracranial operation for brain tumor.

Study Overview

Status

Unknown

Detailed Description

Postoperative delirium is common after major surgery, and is associated with adverse outcomes. However, patients with neurological illness are usually excluded from previous researches. Recently, limited studies have shown that the incidence of postoperative delirium in neurosurgical patients is approximately 20%, which is comparable to the results in other major surgery. Potential associations between postoperative delirium and adverse outcomes have also been found in neurosurgical patients. These results indicate that early prevention of postoperative delirium should be employed in this population.

As a highly selective α2-adrenergic receptor agonist, dexmedetomidine has been investigated as a preventive agent for postoperative delirium. Systematic reviews and meta-analyses of randomized controlled trials have shown that perioperative administration of dexmedetomidine may decrease the incidence of postoperative delirium in patients after either cardiac or non-cardiac surgery. However, neurosurgical patients are often excluded in clinical trials of postoperative delirium.

In this prospective, multicenter, randomized, double-blinded, and placebo-controlled trial with two parallel arms, ICU admitted adult patients after intracranial operation for brain tumor will be enrolled. Low-dose dexmedetomidine will be applied during the early postoperative phase. The investigators aim to evaluate the efficacy and safety of low-dose dexmedetomidine for prevention of postoperative delirium in this patient population. The primary hypothesis is that, compared to the placebo group, the prophylactic use of low-dose dexmedetomidine can decrease the incidence of postoperative delirium without significant adverse events in patients after intracranial operation for brain tumor.

Study Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Phase 4

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 Contact Backup

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100070
        • Intensive Care Unit, Beijing Tiantan Hospital, Capital Medical University
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

The inclusion criteria are adult patients after elective intracranial operation for brain tumor under general anesthesia and who are admitted to the ICU directly from the operating room or postoperative care unit.

The exclusion criteria include:

  1. Admitted to the ICU after 22:00 PM;
  2. Medical records documented preoperative history of mental or cognitive disorders including schizophrenia, epilepsy, Parkinsonism, or dementia;
  3. Medical records documented inability to communicate in the preoperative period due to coma or language barrier;
  4. History of drug abuse of psychoactive and anesthetic drugs;
  5. Known preoperative severe sinus bradycardia (lower than 50 beats/min), sick sinus syndrome, second- or third-degree atrioventricular block, or left ventricular ejection fraction lower than 30%;
  6. Serious hepatic dysfunction (Child-Pugh class C);
  7. Severe renal dysfunction requiring renal replacement therapy before the surgery;
  8. Allergies to ingredients or components of 5-[(1S)-1-(2,3-dimethylphenyl)ethyl]-1H-imidazole (dexmedetomidine hydrochloride);
  9. American Society of Anesthesiologists (ASA) classification of IV to VI;
  10. Moribund condition with low likelihood of survival for more than 24 hours;
  11. Pregnancy or lactation women;
  12. Current enrolment in another clinical trial;
  13. Refuse to participate.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexmedetomidine group
Continuously intravenous infusion of dexmedetomidine hydrochloride at a rate of 0.1 μg/kg/hour (0.025 ml/kg/hour) started immediately after enrollment until 08:00 AM on the postoperative day one.
Dexmedetomidine hydrochloride (200 μg/2 ml) is diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour (dexmedetomidine 0.1 μg/kg/hour). The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
Other Names:
  • Dexmedetomidine hydrochloride
Placebo Comparator: Normal saline group
Continuously intravenous infusion of normal saline at a rate of 0.025 ml/kg/hour started immediately after enrollment until 08:00 AM on the postoperative day one.
Normal saline is also diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour, which is the same with the dexmedetomidine group. The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
Other Names:
  • 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative delirium
Time Frame: From postoperative day 1 to day 5
Postoperative delirium is defined as delirium within 5 postoperative days, which is diagnosed by the Confusion Assessment Method for the ICU (CAM-ICU) evaluated twice daily (8:00-10:00 AM, and 18:00-20:00 PM).
From postoperative day 1 to day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of adverse events
Time Frame: From the start of study agent infusion to postoperative day 1
Include bradycardia (defined as heart rate lower than 55 beats/min), hypotension (defined as systolic blood pressure lower than 90 mmHg), and hypoxemia (defined as pulse oxygen saturation lower than 90%)
From the start of study agent infusion to postoperative day 1
The incidence of non-delirium complications
Time Frame: From the start of study agent infusion to postoperative day 28
Include airway obstruction and apnea, respiratory failure, cardiac events, coma, epilepsy, cerebral hemorrhage or infarction, renal injury and infection
From the start of study agent infusion to postoperative day 28
Length of stay in the ICU
Time Frame: From the start of study agent infusion to postoperative day 28
Time of ICU discharge
From the start of study agent infusion to postoperative day 28
Length of stay in hospital
Time Frame: From the start of study agent infusion to postoperative day 28
Time of hospital discharge
From the start of study agent infusion to postoperative day 28
The incidence of all-caused deaths after the operation
Time Frame: From the start of study agent infusion to postoperative day 28
All of the deaths that occur after the study agent infusion
From the start of study agent infusion to postoperative day 28

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients with the use of sedatives and analgesics
Time Frame: From the start of study agent infusion to postoperative day 1
Include propofol, midazolam, opioids and nonsteroidal anti-inflammatory drugs
From the start of study agent infusion to postoperative day 1
Pain intensity
Time Frame: From the start of study agent infusion to postoperative day 1
Assessed by the critical-care pain observation tool (CPOT) with a total score of 0-8. Higher scores mean a worsening of pain.
From the start of study agent infusion to postoperative day 1
Subjective sleep quality
Time Frame: From the start of study agent infusion to postoperative day 1
Assessed by numerical rating scale (NRS) with a total score of 0-10. Higher scores mean a better sleep.
From the start of study agent infusion to postoperative day 1

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 21, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

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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