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Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Robot-assisted Pancreaticoduodenectomy: a Randomized Controlled Study

Primary Purpose

Delirium in Old Age

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Dexmedetomidine

Saline

About this trial

This is an interventional treatment trial for Delirium in Old Age focused on measuring dexmedetomidine, robot-assisted pancreaticoduodenectomy

Eligibility Criteria

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

Inclusion Criteria:

Patients over 65 years old
Patients undergoing elective robotic-assisted pancreaticoduodenectomy.
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
Pregnant or lactating women
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

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

NCT ID

NCT05274789

First Posted

February 19, 2022

Last Updated

June 26, 2022

Sponsor

Chinese PLA General Hospital

Collaborators

Beijing Tiantan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05274789

Brief Title

Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Robot-assisted Pancreaticoduodenectomy: a Randomized Controlled Study

Official Title

Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Robot-assisted Pancreaticoduodenectomy: a Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 15, 2022 (Actual)

Primary Completion Date

April 1, 2024 (Anticipated)

Study Completion Date

April 1, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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 robot-assisted pancreaticoduodenectomy.

Detailed Description

This study is a multicenter, randomized, double-blind, placebo-controlled trial. Three hundred patients undergoing elective robotic-assisted pancreaticoduodenectomy 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, robot-assisted pancreaticoduodenectomy

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

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.

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.

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

Eligibility Criteria

Inclusion Criteria: Patients over 65 years old Patients undergoing elective robotic-assisted pancreaticoduodenectomy. 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 Pregnant or lactating women 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, Doctor

Phone

15010665099

lihao301@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hao Li, Doctor

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, Doctor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Robot-assisted Pancreaticoduodenectomy: a Randomized Controlled Study

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