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Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

NCT05068180 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-10-06

No results posted yet for this study

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

Interventions

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.

DRUG

Placebo

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

Sponsors & Collaborators

  • Shanghai 8th People's Hospital

    collaborator OTHER

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Diansan Su, Doctor · RenJi Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-05
Primary Completion
2022-04-10
Completion
2022-04-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05068180 on ClinicalTrials.gov