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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2024-04-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Delirium in Old Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo group

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Group Type PLACEBO_COMPARATOR

Saline

Intervention Type 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.

Experimental group

Use dexmedetomidine as experimental group

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No