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

Delirium in Old Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05274789
• Other study ID #: ChinaPLAGH301
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: June 2022
• Source: Chinese PLA General Hospital
• Contact: Hao Li, Doctor
• Phone: 15010665099
• Email: lihao301[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age

Intervention

Drug:
• Dexmedetomidine
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.

Other:
• Saline
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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital,Capital Medical University	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.