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

Sponsor

Second Affiliated Hospital of Nanchang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05847296

Collaborator

(none)

334

Enrollment

Location

8.9

Anticipated Duration (Months)

37.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Delirium Sarcopenia Gastrointestinal Surgery Anesthesia

Study Design

Study Type:

Observational

Anticipated Enrollment :

334 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Second Affiliated Hospital of Nanchang University

Actual Study Start Date :

May 5, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Sarcopenia group
Non sarcopenic group

Outcome Measures

Primary Outcome Measures

Incidence of postoperative delirium [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 Outcome Measures

Systolic pressure [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".
Diastolic pressure [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".
Mean pressure [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".
Heart rate [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".
Incidence of postoperative admission to ICU [Up to 1 month after surgery]
Including immediate postoperative admission to ICU and postoperative admission to ICU in the ward.
Length of stay in ICU [Up to 1 month after surgery]
Duration of stay in ICU after surgery
Postoperative pain [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
Maximum postoperative C-reactive protein (CRP) [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
Minimum postoperative albumin [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
Length of hospitalization [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
Complication [During the perioperative period, up to 1 month after surgery]
All the perioperative complications are recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
ASA Ⅰ-Ⅲ

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