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Clinical Trials/NCT05847296
NCT05847296
Recruiting
Not Applicable

The Second Affiliated Hospital of Nanchang University

Second Affiliated Hospital of Nanchang University1 site in 1 country334 target enrollmentMay 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Delirium
Sponsor
Second Affiliated Hospital of Nanchang University
Enrollment
334
Locations
1
Primary Endpoint
Incidence of postoperative delirium
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 5, 2023
End Date
February 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Second Affiliated Hospital of Nanchang University
Responsible Party
Principal Investigator
Principal Investigator

Fuzhou Hua

Chief Physician

Second Affiliated Hospital of Nanchang University

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 65 years old, gender is not limited
  • Patients to undergo elective abdominal surgery (gastrointestinal tumor resection) under general anesthesia, with an expected operation duration of about 2h\~4h

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Diastolic pressure(Up to 5 hours in the operating room)
  • Postoperative pain(Within 7 days after surgery)
  • Minimum postoperative albumin(Up to 1 month after surgery)
  • Systolic pressure(Up to 5 hours in the operating room)
  • Mean pressure(Up to 5 hours in the operating room)
  • Complication(During the perioperative period, up to 1 month after surgery)
  • Length of stay in ICU(Up to 1 month after surgery)
  • Maximum postoperative C-reactive protein (CRP)(Up to 1 month after surgery)
  • Heart rate(Up to 5 hours in the operating room)
  • Incidence of postoperative admission to ICU(Up to 1 month after surgery)
  • Length of hospitalization(After the patient is discharged from the hospital, average 1 month)

Study Sites (1)

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