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

NCT05847296 | Unknown

• 1 other identifier: 2023-OB-01
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium; Sarcopenia; Gastrointestinal Surgery; Anesthesia

Keywords

Postoperative Delirium; Sarcopenia; Gastrointestinal surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Systolic pressure

  Up to 5 hours in the operating room

• Diastolic pressure

  Up to 5 hours in the operating room

• Mean pressure

  Up to 5 hours in the operating room

• Heart rate

  Up to 5 hours in the operating room

• Incidence of postoperative admission to ICU

  Up to 1 month after surgery

Study Arms (2)

Sarcopenia group

Non sarcopenic group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who come to the Second Affiliated Hospital of Nanchang University for treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

Study Sites (1)

the Second Affiliated Hospital of Nanchang University, Nanchang University

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Sarcopenia

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Muscular Atrophy; Neuromuscular Manifestations; Atrophy; Pathological Conditions, Anatomical

Central Study Contacts

Fuzhou Hua

CONTACT

+8615170238929; huafuzhou@126.com

Wei Wan

CONTACT

+8613767635075; wanwei0207@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: May 5, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

CN (1)