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Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery

Primary Purpose

Delirium in Old Age

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
saline
Dexmedetomidine
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium in Old Age focused on measuring dexmedetomidine

Eligibility Criteria

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

Inclusion Criteria:

  • Patients over 65 years old
  • Patients undergoing elective major abdominal surgery
  • Written informed consent was obtained

Exclusion Criteria:

  • Patients with severe preoperative cognitive impairment (MMSE ≤ 20) who are unable to undergo a follow-up evaluation.
  • Patients with history of psychiatric or neurological disorders.
  • Patients with body mass index ≤ 18 or ≥ 30
  • Patients with severe bradycardia (heart rate less than 40 beats per minute)
  • Patients with pathological sinus node syndrome or grade 2 or greater AV block
  • Patients with severe hepatic or renal insufficiency.
  • Patients with severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)

Sites / Locations

  • Beijing Tiantan Hospital,Capital Medical UniversityRecruiting
  • Chinese PLA General HospitalRecruiting
  • Central theater General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

Experimental group

Arm Description

Use 250 ml of saline as placebo group.

Use dexmedetomidine as experimental group

Outcomes

Primary Outcome Measures

Incidence of postoperative delirium
Participants will be followed for the duration of hospital stay, an expected average of 5 days.Evaluations are conducted twice a day.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2022
Last Updated
September 7, 2023
Sponsor
Chinese PLA General Hospital
Collaborators
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05436964
Brief Title
Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery
Official Title
Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To observe the effect of intraoperative dexmedetomidine on the incidence of postoperative delirium, postoperative analgesic drug requirements and pain scores in elderly patients undergoing major abdominal surgery.
Detailed Description
This study is a multicenter, randomized, double-blind, placebo-controlled trial. Three hundred patients undergoing elective major abdominal surgery were randomized to the intervention and control groups. Patients in the intervention group were given a loading dose of 0.6 μg/kg of dexmedetomidine by intravenous infusion within 10 minutes after intubation, followed by a continuous infusion at a rate of 0.4 μg/kg/h until 30 min before the end of the procedure; patients in the control group were given an equal volume of saline. Data were collected at 1-5 days and 1 month postoperative follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium in Old Age
Keywords
dexmedetomidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Use 250 ml of saline as placebo group.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Use dexmedetomidine as experimental group
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
Patients in the experimental group were given a loading dose of 0.6 μg/kg of saline intravenously after 10 minutes of intubation, followed by a continuous infusion at a rate of 0.4 μg/kg/h until 30 min before the end of the surgery.continuous infusion at a rate of 0.4 μg/kg/h until 30 min before the end of the surgery.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Patients in the experimental group were given a loading dose of 0.6 μg/kg of dexmedetomidine intravenously after 10 minutes of intubation, followed by a continuous infusion at a rate of 0.4 μg/kg/h until 30 min before the end of the surgery.
Primary Outcome Measure Information:
Title
Incidence of postoperative delirium
Description
Participants will be followed for the duration of hospital stay, an expected average of 5 days.Evaluations are conducted twice a day.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over 65 years old Patients undergoing elective major abdominal surgery Written informed consent was obtained Exclusion Criteria: Patients with severe preoperative cognitive impairment (MMSE ≤ 20) who are unable to undergo a follow-up evaluation. Patients with history of psychiatric or neurological disorders. Patients with body mass index ≤ 18 or ≥ 30 Patients with severe bradycardia (heart rate less than 40 beats per minute) Patients with pathological sinus node syndrome or grade 2 or greater AV block Patients with severe hepatic or renal insufficiency. Patients with severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Li
Phone
15010665099
Email
lihao301@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Li
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital,Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YuMing Peng
Phone
13426395670
Email
florapym766@163.com
Facility Name
Chinese PLA General Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Li
Phone
15010665099
Email
lihao301@126.com
Facility Name
Central theater General Hospital
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Zhou

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery

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