Preventive Effects of Low Dose Droperidol on the Postoperative Delirium in Non-cardiac Surgery of Elderly Patients

Sponsor

RenJi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05401058

Collaborator

(none)

1,008

Enrollment

Locations

Arms

Anticipated Duration (Months)

336

Patients Per Site

10.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Digestive System Disease Spinal Disease Urologic Diseases Gynecological Disease	Drug: Droperidol Injection Drug: Saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1008 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Preventive Effects of Low Dose Droperidol on the Postoperative Delirium in Non-cardiac Surgery of Elderly Patients: A Randomized, Double-blind, Placebo-controlled Trial

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Droperidol 1.25mg/0.5ml	Drug: Droperidol Injection About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection. Other Names: D
Placebo Comparator: Placebo group Normal saline 0.5ml	Drug: Saline About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection. Other Names: S

Arm

Intervention/Treatment

Experimental: Experimental group

Droperidol 1.25mg/0.5ml

Drug: Droperidol Injection

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

Other Names:

Placebo Comparator: Placebo group

Normal saline 0.5ml

Drug: Saline

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

Other Names:

Outcome Measures

Primary Outcome Measures

Incidence of delirium within 7 days after operation [7 days after operation]
Incidence of delirium within 7 days after operation

Secondary Outcome Measures

Type, severity, duration of Postoperative delirium [From the end of operation to 7 days after opertation]
Type, severity, duration of Postoperative delirium
Delirium-free days [From the end of operation to 7 days after opertation]
Delirium-free days
Incidence of non-delirium complications after surgery [From the end of operation to discharge, an average of 1 week]
Incidence of non-delirium complications after surgery
Length of stay in PACU [From entering PACU to leaving PACU, an average of 1 hour]
Length of stay in PACU
Length of hospital stay [From hospitalization to discharge, an average of 1 week]
Length of hospital stay
Total cost of hospitalization [From hospitalization to discharge, an average of 1 week]
Total cost of hospitalization
Mortality during hospitalization [From hospitalization to discharge, an average of 1 week]
Mortality during hospitalization
All-cause 30-day mortality after surgery [30 days after operation]
All-cause 30-day mortality after surgery
Postoperative delirium incidence at 1 year [1 year after surgery]
Postoperative delirium incidence at 1 year
mortality of Postoperative delirium at 1 year [1 year after surgery]
mortality of Postoperative delirium at 1 year
cognitive function at 1 year [1 year after surgery]
cognitive function at 1 year
Time to extubation in PACU [From entering PACU to leaving PACU, an average of 1 hour]
Time to extubation in PACU

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age≥65 years and <80 years
American Society of Anesthesiologists (ASA): I-III
Planning to undergo elective non-cardiac surgery under general anesthesia with endotracheal intubation, including digestive, spinal, urologic and gynecological surgery
Estimated operation time more than 2 hours
Not admitted to ICU after surgery
Proficient in Chinese
Voluntary signature of informed consent

Exclusion Criteria:

Morbid obesity with BMI >35;
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);
Preoperative renal insufficiency (Dialysis required);
Severe heart failure [Metablic equivalent (METs)<4];
Allergic to droperidol;
Inability to communicate due to coma or dementia in preoperative period;
Delirium before operation;
Alcohol abuse;
Participating in other clinical trials;
Planning to receive second operation within 7 days after first operation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China
2	Henan Provincial People Hospital	Zhengzhou	Henan	China
3	Renji Hospital, Shanghai Jiaotong University School of Medicine	Pudong	Shanghai	China	200127