Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Robot-assisted Pancreaticoduodenectomy: a Randomized Controlled Study

Not Applicable

• Conditions: Delirium in Old Age
• Interventions: Other: Saline; Drug: Dexmedetomidine

• Registration Number: NCT05274789
• Lead Sponsor: Chinese PLA General Hospital

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 robot-assisted pancreaticoduodenectomy.

Detailed Description

This study is a multicenter, randomized, double-blind, placebo-controlled trial. Three hundred patients undergoing elective robotic-assisted pancreaticoduodenectomy 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 Timeline

• Study First Submitted: 2022-02-19
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-10
• Study Start: 2022-04-15
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-26
• Last Update Posted: 2022-06-30
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients over 65 years old
• Patients undergoing elective robotic-assisted pancreaticoduodenectomy.
• 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
• Pregnant or lactating women
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Saline	Use 250 ml of saline as placebo group.
Experimental group	Dexmedetomidine	Use dexmedetomidine as experimental group

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative delirium	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital,Capital Medical University; 🇨🇳 Beijing, China