Clinical trial NCT05847296: Effect of Preoperative Sarcopenia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery
Official title: The Second Affiliated Hospital of Nanchang University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Delirium
Sarcopenia
Gastrointestinal Surgery
Anesthesia
Keywords: Postoperative Delirium
Sarcopenia
Gastrointestinal surgery
Anesthesia
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 334
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who come to the Second Affiliated Hospital of Nanchang University for treatment

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: Within 7 days after surgery. Delirium at any time during the 7 days after surgery was considered postoperative delirium.
Secondary outcomes:
measure: Systolic pressure
timeFrame: Up to 5 hours in the operating room
measure: Diastolic pressure
timeFrame: Up to 5 hours in the operating room
measure: Mean pressure
timeFrame: Up to 5 hours in the operating room
measure: Heart rate
timeFrame: Up to 5 hours in the operating room
measure: Incidence of postoperative admission to ICU
timeFrame: Up to 1 month after surgery
measure: Length of stay in ICU
timeFrame: Up to 1 month after surgery
measure: Postoperative pain
timeFrame: Within 7 days after surgery
measure: Maximum postoperative C-reactive protein (CRP)
timeFrame: Up to 1 month after surgery
measure: Minimum postoperative albumin
timeFrame: Up to 1 month after surgery
measure: Length of hospitalization
timeFrame: After the patient is discharged from the hospital, average 1 month
measure: Complication
timeFrame: During the perioperative period, up to 1 month after surgery
Other outcomes:
Locations:
city: Nanchang
country: China
facility: the Second Affiliated Hospital of Nanchang University, Nanchang University
state: Jiangxi
Study officials:
References: