Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Robot-assisted Pancreaticoduodenectomy: a Randomized Controlled Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo group Use 250 ml of saline as placebo group. |
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.
|
| Experimental: Experimental group Use dexmedetomidine as experimental group |
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.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients over 65 years old
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Patients undergoing elective robotic-assisted pancreaticoduodenectomy.
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Written informed consent was obtained.
Exclusion Criteria:
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Patients with severe preoperative cognitive impairment (MMSE ≤ 20) who are unable to undergo a follow-up evaluation.
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Patients with history of psychiatric or neurological disorders.
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Patients with body mass index ≤ 18 or ≥ 30
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Pregnant or lactating women
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Patients with severe bradycardia (heart rate less than 40 beats per minute)
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Patients with pathological sinus node syndrome or grade 2 or greater AV block
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Patients with severe hepatic or renal insufficiency.
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Patients with severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Tiantan Hospital,Capital Medical University | Beijing | China |
Sponsors and Collaborators
- Chinese PLA General Hospital
- Beijing Tiantan Hospital
Investigators
- Principal Investigator: Hao Li, Doctor, Chinese PLA General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ChinaPLAGH301