Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2022-04-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05401058

Digestive System Disease Urologic Diseases Gynecological Disease +1 more

UNKNOWN NA

Elderly Patients Undergoing Surgery During Perioperative Period

NCT07314762

Postoperative Complications Elderly Postoperative Delirium (POD) +2 more

RECRUITING

Associations of Postoperative Delirium With Perioperative Frailty Worsening and Their Combined Effect on 1-Year Mortality in Older Surgical Patients

NCT07259850

Postoperative Delirium (POD) Frailty at Older Adults Mortality +1 more

COMPLETED

Dexmedetomidine Supplemented Analgesia and Incidence of Postoperative Delirium

NCT03012984

Surgery Analgesia Dexmedetomidine +3 more

COMPLETED NA

The Effect of Early Postoperative Pain on Postoperative Delirium (POD) in Elderly Patients Undergoing Abdominal Surgery

NCT06964893

Postoperative Delirium (POD)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stomach Neoplasms Colonic Neoplasms Rectal Neoplasms Sigmoid Neoplasms Liver Neoplasms Kidney Neoplasms Urinary Bladder Neoplasms Prostatic Neoplasms Osteoarthropathy Fractures, Bone Gynecologic Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neuroleptanalgesia group

Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure.

Group Type EXPERIMENTAL

low-dose neuroleptanalgesia

Intervention Type DRUG

Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure.

Control group

The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

low-dose neuroleptanalgesia

Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure.

Intervention Type DRUG

Placebo

The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 65 years old and ≤ 85 years old;
2. Selective non-cardiac major surgery;
3. Informed consent and voluntary participation in the trial;
4. ASA class I-II;
5. Anticipated operation duration ≥ 2 hours;
6. No plan to ICU after operation.

Exclusion Criteria

1. Neurosurgery;
2. Patients with neurological and mental diseases: such as basal ganglia disease, Parkinson's syndrome, severe central nervous depression, Alzheimer's disease , etc;
3. Patients with prolonged Q-T interval, cardiac repolarization disorder and other severe arrhythmia;
4. Patients with severe cardiopulmonary disease, liver and kidney dysfunction;
5. Allergic or contraindications to droperidol or fentanyl citrate;
6. Admitted to ICU after operation.
7. Operation duration \< 2 hours;

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No