Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

Prostatic Neoplasms Clinical Trial

Official title:

Low-dose Neuroleptanalgesia Reduce the Occurrences of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Major Surgery : a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068180
• Other study ID #: KY2020-125
• Status: Recruiting
• Phase: Phase 4
• Start date: October 5, 2021
• Est. completion date: April 10, 2022

Study information

• Verified date: October 2021
• Source: RenJi Hospital
• Contact: Diansan Su, Doctor
• Phone: 18616514088
• Email: 184872238[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 10, 2022
• Est. primary completion date: April 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
China	Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Eighth People's Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
RenJi Hospital	Shanghai 8th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery		Up to 7 days after surgery(or leaving hospital)
Secondary	Length of hospital stay		Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary	Incidence of postoperative nausea and vomiting		Up to 7 days after surgery(or leaving hospital)
Secondary	Patients' satisfaction	This outcome will be measured using a numeric rating scale from 1 ( dissatisfaction ) to 3 (very satisfied)	Up to 7 days after surgery(or leaving hospital)
Secondary	Incidence of postoperative hypoxia		Up to 1 day after surgery
Secondary	Incidence of major serious complications and serious arrhythmia		Up to 7 days after surgery(or leaving hospital)
Secondary	Duration of postoperative delirium		Up to 7 days after surgery(or leaving hospital)