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NCT Number: NCT05436964

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

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital,Capital Medical University, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Saline

Other

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.

Dexmedetomidine

Drug

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 outcomes

  1. Incidence of postoperative delirium

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

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

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Tiantan Hospital

Registry information

Official study title

Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Major Abdominal Surgery: a Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 29, 2022
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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