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

C

Chinese PLA General Hospital (301 Hospital)

Status

Enrolling

Conditions

Delirium in Old Age

Treatments

Drug: Dexmedetomidine
Other: saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05436964
ChinesePLAGH301

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

300 participants in 2 patient groups, including a placebo group

Placebo group
Placebo Comparator group
Description:
Use 250 ml of saline as placebo group.
Treatment:
Other: saline
Experimental group
Experimental group
Description:
Use dexmedetomidine as experimental group
Treatment:
Drug: Dexmedetomidine

Trial contacts and locations

3

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Central trial contact

Hao Li

Data sourced from clinicaltrials.gov

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