search
Back to results

Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

Primary Purpose

Dexmedetomidine, Postoperative Delirium

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
0.9% saline
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dexmedetomidine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing selective frontotemporal tumor resection.
  • Age ≥18 years.
  • Obtain written informed consent.

Exclusion Criteria:

  • Refusal to provide written informed consent.
  • Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20).
  • Allergic to the study drug.
  • History of psychotropic drugs within past 30 days.
  • Pregnant or lactating women.
  • History of traumatic brain injury or neurosurgery.
  • Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block.
  • Severe hepatic or renal dysfunction.

Sites / Locations

  • Beijing TianTan Hospital,Capital Medical University
  • PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DEX group

Placebo group

Arm Description

The DEX group will receives dexmedetomidine intraoperative.

The placebo group will receives 0.9% saline intraoperative.

Outcomes

Primary Outcome Measures

The incidence of postoperative delirium
Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable. Delirium consists of four main characteristics: acute onset of a change in mental status or a fluctuating level of consciousness, inattention, disorganized thinking and an altered level of consciousness. The patient was diagnosed as delirious if both the first and second features were present, and either the third or fourth was present. In the ICU, the delirium assessment was performed in two steps. The arousal level was first assessed by RASS. If the patient was not responsive to verbal stimuli (i.e. RASS score ≤-4), the remaining delirium assessment was aborted, and the patient was recorded as comatose. When the RASS score was greater than or equal to 3, delirium was evaluated using the CAM-ICU. Patients in general ward were evaluated by 3D-CAM.

Secondary Outcome Measures

Pain score
Numerical Rating Scales, ranging from 0 to 10 points, with 10 representing the worst imaginable pain.
Sleep quality
Quality of sleep was assessed by the Richards Campbell sleep questionnaire (RCSQ) and with a 0-100-mm visual analog scale, with higher scores indicating better sleep quality.
Quality of recovery from surgery
Postoperative quality of recovery was assessed through the Quality of Recovery 15 item
Intraoperative cardiovascular event.
Including: hypotension was defined as systolic blood pressure <95 mm Hg or less than 30% below baseline; hypertension was defined as systolic blood pressure > 180 mm Hg or more than 30% above baseline; bradycardia was defined by heart rate <40 bpm, and tachycardia was defined by heart rate >100 bpm.

Full Information

First Posted
December 13, 2020
Last Updated
March 22, 2022
Sponsor
Beijing Tiantan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04674241
Brief Title
Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections
Official Title
Effect of Dexmedetomidine on Postoperative Delirium in Patients Undergoing Brain Tumor Resections: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Postoperative delirium (POD) is a common complication, and the incidence rate is about 25% in non cardiac surgery. Previous studies have reported that the total incidence of neurological pod ranged from 10% to 22%. Dexmedetomidine (DEX) is an a-2 adrenergic agonist for sedation. This kind of drug has little effect on respiratory function, is easy to wake up and has analgesic effect. It is a commonly used perioperative adjuvant drug. However, for neurosurgical patients with brain tumors, the role of DEX in POD is not clear. The purpose of this study was to investigate the effect of DEX on POD in neurosurgical brain tumor surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Postoperative Delirium

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEX group
Arm Type
Active Comparator
Arm Description
The DEX group will receives dexmedetomidine intraoperative.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The placebo group will receives 0.9% saline intraoperative.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Ten minutes after anesthesia induction and endotracheal intubation, patients assigned to dexmedetomidine group were given a loading dose of dexmedetomidine 0.6 μg/kg over 10 minutes, followed by continuous infusion at a rate of 0.4 μg/kg/h until the start of dural closure.
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Intervention Description
0.9% saline is administered with the same volume at the same speed as the other group.
Primary Outcome Measure Information:
Title
The incidence of postoperative delirium
Description
Postoperative delirium is assessed by the combination of the Richmond Anxiety Scale (RASS) and the Confusion assessment method for intensive care unit (CAM-ICU) or the 3-minute diagnostic interview for CAM (3D-CAM) as applicable. Delirium consists of four main characteristics: acute onset of a change in mental status or a fluctuating level of consciousness, inattention, disorganized thinking and an altered level of consciousness. The patient was diagnosed as delirious if both the first and second features were present, and either the third or fourth was present. In the ICU, the delirium assessment was performed in two steps. The arousal level was first assessed by RASS. If the patient was not responsive to verbal stimuli (i.e. RASS score ≤-4), the remaining delirium assessment was aborted, and the patient was recorded as comatose. When the RASS score was greater than or equal to 3, delirium was evaluated using the CAM-ICU. Patients in general ward were evaluated by 3D-CAM.
Time Frame
postoperative 5 day
Secondary Outcome Measure Information:
Title
Pain score
Description
Numerical Rating Scales, ranging from 0 to 10 points, with 10 representing the worst imaginable pain.
Time Frame
within 5 days after surgery
Title
Sleep quality
Description
Quality of sleep was assessed by the Richards Campbell sleep questionnaire (RCSQ) and with a 0-100-mm visual analog scale, with higher scores indicating better sleep quality.
Time Frame
within 3 days after surgery
Title
Quality of recovery from surgery
Description
Postoperative quality of recovery was assessed through the Quality of Recovery 15 item
Time Frame
1 day after surgery
Title
Intraoperative cardiovascular event.
Description
Including: hypotension was defined as systolic blood pressure <95 mm Hg or less than 30% below baseline; hypertension was defined as systolic blood pressure > 180 mm Hg or more than 30% above baseline; bradycardia was defined by heart rate <40 bpm, and tachycardia was defined by heart rate >100 bpm.
Time Frame
From the study drug infusion to the end of surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing selective frontotemporal tumor resection. Age ≥18 years. Obtain written informed consent. Exclusion Criteria: Refusal to provide written informed consent. Preoperative severe cognitive impairment (mini-mental state examination, MMSE ≤ 20). Allergic to the study drug. History of psychotropic drugs within past 30 days. Pregnant or lactating women. History of traumatic brain injury or neurosurgery. Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block. Severe hepatic or renal dysfunction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Ming Peng, MD,Ph.D
Organizational Affiliation
Beijing Tian Tan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing TianTan Hospital,Capital Medical University
City
Beijing
State/Province
Beijing,China
ZIP/Postal Code
100070
Country
China
Facility Name
PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34758995
Citation
Wang D, Li R, Li S, Wang J, Zeng M, Dong J, Liu X, Lin N, Peng Y. Effect of dexmedetomidine on postoperative delirium in patients undergoing brain tumour resections: study protocol of a randomised controlled trial. BMJ Open. 2021 Nov 10;11(11):e051584. doi: 10.1136/bmjopen-2021-051584.
Results Reference
derived

Learn more about this trial

Dexmedetomidine Alleviates Postoperative Delirium After Brain Tumor Resections

We'll reach out to this number within 24 hrs