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Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

Primary Purpose

Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

low-dose neuroleptanalgesia

Placebo

About this trial

This is an interventional prevention trial for Stomach Neoplasms focused on measuring Postoperative delirium, Neuroleptanalgesia, Aged, Noncardiac major surgery

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;

Sites / Locations

Ren Ji Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
Shanghai Eighth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Neuroleptanalgesia group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of hospital stay

Incidence of postoperative nausea and vomiting

Patients' satisfaction

This outcome will be measured using a numeric rating scale from 1 ( dissatisfaction ) to 3 (very satisfied)

Incidence of postoperative hypoxia

Incidence of major serious complications and serious arrhythmia

Duration of postoperative delirium

Full Information

NCT ID

NCT05068180

First Posted

September 6, 2021

Last Updated

October 4, 2021

Sponsor

RenJi Hospital

Collaborators

Shanghai 8th People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05068180

Brief Title

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 5, 2021 (Actual)

Primary Completion Date

April 10, 2022 (Anticipated)

Study Completion Date

April 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

Collaborators

Shanghai 8th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neuroleptanalgesia group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

low-dose neuroleptanalgesia

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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）

Secondary Outcome Measure Information:

Title

Length of hospital stay

Time Frame

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

Title

Incidence of postoperative nausea and vomiting

Time Frame

Up to 7 days after surgery（or leaving hospital）

Title

Patients' satisfaction

Description

This outcome will be measured using a numeric rating scale from 1 ( dissatisfaction ) to 3 (very satisfied)

Time Frame

Up to 7 days after surgery（or leaving hospital）

Title

Incidence of postoperative hypoxia

Time Frame

Up to 1 day after surgery

Title

Incidence of major serious complications and serious arrhythmia

Time Frame

Up to 7 days after surgery（or leaving hospital）

Title

Duration of postoperative delirium

Time Frame

Up to 7 days after surgery（or leaving hospital）

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Diansan Su, Doctor

Phone

18616514088

184872238@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhenling Huang, Doctor

Phone

18964381971

2993252569@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diansan Su, Doctor

Organizational Affiliation

RenJi Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhenling Huang, Doctor

Phone

18964381971

2993252569@qq.com

First Name & Middle Initial & Last Name & Degree

Xiao Zhang, MS

Phone

18317087118

fdzhangxiao@126.com

Facility Name

Shanghai Eighth People's Hospital

City

Shanghai

State/Province

Shanghai

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cuixia Song, BS

Phone

13817874048

songcuixia2001@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

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