Clinical trial NCT05068180: Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
Official title: Low-dose Neuroleptanalgesia Reduce the Occurrences of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Major Surgery : a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stomach Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Sigmoid Neoplasms
Liver Neoplasms
Kidney Neoplasms
Urinary Bladder Neoplasms
Prostatic Neoplasms
Osteoarthropathy
Fractures, Bone
Gynecologic Cancer
Keywords: Postoperative delirium
Neuroleptanalgesia
Aged
Noncardiac major surgery
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai 8th People's Hospital
First posted: 2021-10-05
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery
timeFrame: Up to 7 days after surgery（or leaving hospital）
Secondary outcomes:
measure: Length of hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Incidence of postoperative nausea and vomiting
timeFrame: Up to 7 days after surgery（or leaving hospital）
measure: Patients' satisfaction
timeFrame: Up to 7 days after surgery（or leaving hospital）
measure: Incidence of postoperative hypoxia
timeFrame: Up to 1 day after surgery
measure: Incidence of major serious complications and serious arrhythmia
timeFrame: Up to 7 days after surgery（or leaving hospital）
measure: Duration of postoperative delirium
timeFrame: Up to 7 days after surgery（or leaving hospital）
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Eighth People's Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Diansan Su, Doctor
role: STUDY_CHAIR
References: