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

Study Overview
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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.

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.

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

Conditions
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Delirium in Old Age

Intervention / Treatment
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* Drug: Dexmedetomidine
* Other: Saline


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Use 250 ml of saline as placebo group. | Other: Saline<br>* 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.<br>|
| Experimental: Experimental group<br>Use dexmedetomidine as experimental group | Drug: Dexmedetomidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, robot-assisted pancreaticoduodenectomy