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

NCT05436964 | Completed DMC

• 1 other identifier: ChinesePLAGH301
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Delirium in Old Age

Keywords

dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Use 250 ml of saline as placebo group.

Other: saline

Experimental group

EXPERIMENTAL

Use dexmedetomidine as experimental group

Drug: Dexmedetomidine

Interventions

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.

Placebo group

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.

Experimental group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients over 65 years old
• Patients undergoing elective major abdominal surgery
• Written informed consent was obtained

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Tiantan Hospital: collaborator

Study Sites (3)

Beijing Tiantan Hospital,Capital Medical University

Beijing, China

Location

Chinese PLA General Hospital

Beijing, China

Location

Central theater General Hospital

Wuhan, China

Location

MeSH Terms

Interventions

Sodium Chloride; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hao Li

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: June 29, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)