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

Anesthesia Clinical Trial

Official title:

The Second Affiliated Hospital of Nanchang University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847296
• Other study ID #: 2023-OB-01
• Status: Recruiting
• Start date: May 5, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2023
• Source: Second Affiliated Hospital of Nanchang University
• Contact: Fuzhou Hua
• Phone: +8615170238929
• Email: huafuzhou[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 334
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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 ?-?

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

Related Conditions & MeSH terms

• Anesthesia
• Delirium
• Gastrointestinal Surgery
• Postoperative Delirium
• Sarcopenia

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Nanchang University, Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

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