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

NCT05401058 | Unknown DMC

• 1 other identifier: DECPOD-DP
• Study Type: interventional
• Target: 2,968
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Digestive System Disease; Urologic Diseases; Gynecological Disease; Orthopedic Surgery

Keywords

non-cardiac surgery; Droperidol; postoperative delirium; elderly patients

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium within 7 days after operation

  Incidence of delirium within 7 days after operation

  7 days after operation

Secondary Outcomes (4)

• Severity of delirium

  From the end of operation to 7 days after opertation

• Delirium-free days

  From the end of operation to 7 days after opertation

• Postoperative hospital duration

  From end of operation to discharge, an average of 1 week

• cognitive function at 30 days and 6 months

  30 days and 6 months after surgery

Study Arms (2)

Experimental group

EXPERIMENTAL

Droperidol 1.25mg/0.5ml

Drug: Droperidol Injection

Placebo group

PLACEBO COMPARATOR

Normal saline 0.5ml

Drug: Saline

Interventions

Droperidol Injection DRUG

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

Also known as: D

Experimental group

Saline DRUG

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

Also known as: S

Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (6)

The first Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

NOT YET RECRUITING

Henan Provincial People Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

Renji Hospital, Shanghai Jiaotong University School of Medicine

Pudong, Shanghai Municipality, 200127, China

RECRUITING

Second hospital of Shanxi Medical University

Taiyuan, Shanxi, China

NOT YET RECRUITING

Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)

Chengdu, Sichuan, China

NOT YET RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Digestive System Diseases; Urologic Diseases; Genital Diseases, Female; Emergence Delirium

Interventions

Droperidol; Fumigant 93; Sodium Chloride

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Diansan Su, MD,PHD

  Renji Hospital, Shanghai Jiaotong University, School of Medcine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diansan Su, MD,PHD

CONTACT

+8618616514088; diansansu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 2, 2022
• Study Start: November 21, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 23, 2023

Record last verified: 2023-01

Locations

CN (6)