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

NCT05274789 | Unknown

• 1 other identifier: ChinaPLAGH301
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium in Old Age

Keywords

dexmedetomidine; robot-assisted pancreaticoduodenectomy

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

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

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.

Placebo 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 robotic-assisted pancreaticoduodenectomy.
• 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
• 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)

Sponsors & Collaborators

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

Study Sites (1)

Beijing Tiantan Hospital,Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

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

Study Officials

• Hao Li, Doctor

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Li, Doctor

CONTACT

15010665099; lihao301@126.com

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: February 19, 2022
• First Posted: March 10, 2022
• Study Start: April 15, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)