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

Chinese PLA General Hospital268 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

268

Conditions

Delirium in Old Age

Interventions

salineOTHER

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.

DexmedetomidineDRUG

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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)

Locations (3)

Beijing Tiantan Hospital,Capital Medical University

Beijing, China

Chinese PLA General Hospital

Beijing, China

Central theater General Hospital

Wuhan, China

Outcomes

Primary Outcomes

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.

Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days

Data from ClinicalTrials.gov

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