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

Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery: 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 major abdominal surgery.

Study Overview

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

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.

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

Contacts and Locations

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

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese PLA General hospital
    • Contact: Hao Li; Phone Number: 15010665099; Email: lihao301@126.com
  • Beijing, China
    • Recruiting
    • Beijing Tiantan Hospital,Capital Medical University
    • Contact: YuMing Peng; Phone Number: 13426395670; Email: florapym766@163.com
  • Wuhan, China
    • Not yet recruiting
    • Central theater General Hospital
    • Contact: Xiang Zhou

Participation Criteria

Eligibility Criteria

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

Description

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)

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.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, Chinese PLA General hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 26, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: dexmedetomidine
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence 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: ChinesePLAGH301

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