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

Recruiting

• Conditions: Postoperative Delirium; Gastrointestinal Surgery; Anesthesia; Sarcopenia

• Registration Number: NCT05847296
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-04-26
• Status Verified: 2023-05
• Study Start: 2023-05-05
• Study First Posted: 2023-05-06
• Last Update Submitted: 2023-05-06
• Last Update Posted: 2023-05-09
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 334

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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".
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
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
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".
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".
Complication	During the perioperative period, up to 1 month after surgery	All the perioperative complications are recorded
Length of stay in ICU	Up to 1 month after surgery	Duration of stay in ICU after surgery
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
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 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

Trial Locations

Locations (1)

the Second Affiliated Hospital of Nanchang University, Nanchang University; 🇨🇳 Nanchang, Jiangxi, China