Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

October 4, 2021 updated by: RenJi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Shanghai Eighth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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 Comparator: Control group
The same volume of normal saline 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery
Time Frame: Up to 7 days after surgery（or leaving hospital）
Up to 7 days after surgery（or leaving hospital）

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Incidence of postoperative nausea and vomiting
Time Frame: Up to 7 days after surgery（or leaving hospital）
Up to 7 days after surgery（or leaving hospital）
Patients' satisfaction
Time Frame: Up to 7 days after surgery（or leaving hospital）
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）
Incidence of postoperative hypoxia
Time Frame: Up to 1 day after surgery
Up to 1 day after surgery
Incidence of major serious complications and serious arrhythmia
Time Frame: Up to 7 days after surgery（or leaving hospital）
Up to 7 days after surgery（or leaving hospital）
Duration of postoperative delirium
Time Frame: Up to 7 days after surgery（or leaving hospital）
Up to 7 days after surgery（or leaving hospital）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Shanghai 8th People's Hospital

Investigators

  • Study Chair: Diansan Su, Doctor, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Anticipated)

April 10, 2022

Study Completion (Anticipated)

April 10, 2022

Study Registration Dates

First Submitted

September 6, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

October 5, 2021

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2020-125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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