Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery

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

2968 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-21

Study Completion Date

2024-12-31

Brief Summary

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The aim of this multicenter, prospective, randomized, double-blind and large sample study is to explore the preventive effect of low-dose droperidol on POD in elderly patients after non-cardiac surgery, providing new approach for reducing the incidence of POD and improving the prognosis and quality of life.

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Detailed Description

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Conditions

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Digestive System Disease Urologic Diseases Gynecological Disease Orthopedic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

Droperidol 1.25mg/0.5ml

Group Type EXPERIMENTAL

Droperidol Injection

Intervention Type DRUG

About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection.

Placebo group

Normal saline 0.5ml

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection.

Interventions

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Droperidol Injection

About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection.

Intervention Type DRUG

Saline

About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection.

Intervention Type DRUG

Other Intervention Names

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D S

Eligibility Criteria

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Inclusion Criteria

* Age≥65 years
* American Society of Anesthesiologists (ASA): I-III
* Planning to undergo elective non-cardiac surgery under general anesthesia with endotracheal intubation, including digestive, orthopedic, urologic and gynecological surgery
* Estimated operation time more than 2 hours
* Not expected to be admitted to ICU postoperatively
* Proficient in Chinese
* Informed consent

Exclusion Criteria

* Morbid obesity with BMI \>35 kg/m2;
* History of psychological and neurological diseases, such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc;
* Corrected QT (QTc) of electrocardiogram\> 500ms;
* Preoperative liver insufficiency (Child Pugh grade C);
* End-stage renal disease requiring dialysis;
* Severe heart failure \[Metablic equivalent (METs)\<4\];
* Allergic to droperidol;
* Inability to communicate due to coma or dementia in preoperative period;
* Preoperative delirium, assessed by 3D-CAM;
* More than three standard alcoholic drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits);
* Participating in conflicting clinical trials;
* Expected to have an additional operation within 7 days after the index operation.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diansan Su, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital, Shanghai Jiaotong University, School of Medcine

Locations

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