Effect of Preoperative Sarcopenia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery

May 6, 2023 updated by: Fuzhou Hua, Second Affiliated Hospital of Nanchang University

The Second Affiliated Hospital of Nanchang University

The goal of this observational study is to compare Incidence of postoperative delirium in Sarcopenic and non-sarcopenic elderly patients undergoing gastrointestinal surgery. The main question it aims to answer are:

• Effect of preoperative sarcopenia on postoperative delirium in elderly patients undergoing gastrointestinal surgery Participants will be evaluated preoperatively for sarcopenia and assessed for postoperative delirium, pain, etc.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

334

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
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • the Second Affiliated Hospital of Nanchang University, Nanchang University
        • 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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients who come to the Second Affiliated Hospital of Nanchang University for treatment

Description

Inclusion Criteria:

  1. Age ≥ 65 years old, gender is not limited
  2. Patients to undergo elective abdominal surgery (gastrointestinal tumor resection) under general anesthesia, with an expected operation duration of about 2h~4h
  3. ASA Ⅰ-Ⅲ

Exclusion Criteria:

  1. Relative contraindications to general anesthesia: Patients with severe heart and lung disease, severe infection, uncontrolled hypertension, diabetes, and severe diabetic complications
  2. Abnormal renal and liver function: AST or ALT≥2.5×ULN, TBIL≥1.5×ULN, Serum creatinine concentration (SCC)≥1.5×ULN
  3. People with a history of mental illness or long-term use of psychotropic drugs (dementia, schizophrenia), chronic analgesic drug use, alcoholism, and cognitive impairment
  4. Any cardiovascular or cerebrovascular accidents occurred within 3 months, such as myocardial infarction, stroke, transient ischemic attack
  5. Myasthenia gravis patients
  6. Unable to cooperate to complete the test, the patient or family member rejected the participant

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

Cohorts and Interventions

Group / Cohort
Sarcopenia group
Non sarcopenic group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative delirium
Time Frame: Within 7 days after surgery. Delirium at any time during the 7 days after surgery was considered postoperative delirium.
Postoperative delirium was assessed using the 3D-CAM scale. It consists of 4 features, and a positive feature 1 and 2 plus 3 or 4 is considered postoperative delirium.
Within 7 days after surgery. Delirium at any time during the 7 days after surgery was considered postoperative delirium.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic pressure
Time Frame: Up to 5 hours in the operating room
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Up to 5 hours in the operating room
Diastolic pressure
Time Frame: Up to 5 hours in the operating room
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Up to 5 hours in the operating room
Mean pressure
Time Frame: Up to 5 hours in the operating room
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Up to 5 hours in the operating room
Heart rate
Time Frame: Up to 5 hours in the operating room
"just entering the operating room", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the operating room".
Up to 5 hours in the operating room
Incidence of postoperative admission to ICU
Time Frame: Up to 1 month after surgery
Including immediate postoperative admission to ICU and postoperative admission to ICU in the ward.
Up to 1 month after surgery
Length of stay in ICU
Time Frame: Up to 1 month after surgery
Duration of stay in ICU after surgery
Up to 1 month after surgery
Postoperative pain
Time Frame: Within 7 days after surgery
The degree of postoperative pain was assessed using the Numerical Rating Scale (NRS). The pain level increased sequentially from 0-10
Within 7 days after surgery
Maximum postoperative C-reactive protein (CRP)
Time Frame: Up to 1 month after surgery
Only the highest CRP values detected in the normal course of gastrointestinal surgery are collected, and no additional blood sampling or interventions are performed
Up to 1 month after surgery
Minimum postoperative albumin
Time Frame: Up to 1 month after surgery
Only the lowest albumin values detected in the normal course of gastrointestinal surgery are collected, and no additional blood sampling or interventions are performed
Up to 1 month after surgery
Length of hospitalization
Time Frame: After the patient is discharged from the hospital, average 1 month
The total number of days the patient spent at the hospital for the current consultation
After the patient is discharged from the hospital, average 1 month
Complication
Time Frame: During the perioperative period, up to 1 month after surgery
All the perioperative complications are recorded
During the perioperative period, up to 1 month after surgery

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital of Nanchang University

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)

May 5, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-OB-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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