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

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.

Study Overview

• Status: Recruiting
• Conditions: Delirium in Old Age
• Intervention / Treatment: Drug: Dexmedetomidine; Other: Saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao Li, Doctor; Phone Number: 15010665099; Email: lihao301@126.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tiantan Hospital,Capital Medical University
    • Contact: Yuming Peng, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; Use 250 ml of saline as placebo group.	Other: Saline; 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.
Experimental: Experimental group; Use dexmedetomidine as experimental group	Drug: Dexmedetomidine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participants will be followed for the duration of hospital stay, an expected average of 5 days.

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Hao Li, Doctor, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: February 19, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 26, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: dexmedetomidine; robot-assisted pancreaticoduodenectomy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: ChinaPLAGH301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No