Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

NCT05068180 | Unknown Phase 4

• 1 other identifier: KY2020-125
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery

  Up to 7 days after surgery（or leaving hospital）

Secondary Outcomes (6)

• Length of hospital stay

  Participants will be followed for the duration of hospital stay, an expected average of 7 days

• Incidence of postoperative nausea and vomiting

  Up to 7 days after surgery（or leaving hospital）

• Patients' satisfaction

  Up to 7 days after surgery（or leaving hospital）

• Incidence of postoperative hypoxia

  Up to 1 day after surgery

• Incidence of major serious complications and serious arrhythmia

  Up to 7 days after surgery（or leaving hospital）

Study Arms (2)

Neuroleptanalgesia group

EXPERIMENTAL

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.

Drug: low-dose neuroleptanalgesia

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

low-dose neuroleptanalgesia 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.

Neuroleptanalgesia group

Placebo DRUG

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

Control group

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead
• Shanghai 8th People's Hospital: collaborator

Study Sites (2)

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Shanghai Eighth People's Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Sigmoid Neoplasms; Liver Neoplasms; Kidney Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms; Fractures, Bone; Emergence Delirium

Interventions

Neuroleptanalgesia

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Sigmoid Diseases; Liver Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Wounds and Injuries; 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)

Analgesia; Anesthesia and Analgesia

Study Officials

• Diansan Su, Doctor

  RenJi Hospital

  STUDY CHAIR

Central Study Contacts

Diansan Su, Doctor

CONTACT

18616514088; 184872238@qq.com

Zhenling Huang, Doctor

CONTACT

18964381971; 2993252569@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: September 6, 2021
• First Posted: October 5, 2021
• Study Start: October 5, 2021
• Primary Completion: April 10, 2022
• Study Completion: April 10, 2022
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)