Anxiety Before Non-cardiac Surgery in Adults

NCT05596188 | Unknown

• 1 other identifier: SSY04070224
• Study Type: observational
• Target: 424
• Locations: 1 country
• Sites: 1

Brief Summary

Adult patients undergoing elective non-cardiac surgery were enrolled. Anxiety before the operation was evaluated by The State Anxiety Inventory (S-AI). Logistics regression would be used for identifying the independent factors of preoperative anxiety and prediction model would be established.

Conditions

Myoma of Uterus; Colon Cancer; Gastric Carcinoma; Prostate Cancer; Femoral Head Necrosis

Outcome Measures

Primary Outcomes (1)

• Independent risk factors of preoperative anxiety and establishment of prediction model

  To identify the independent factors related to preoperative anxiety, which would be analyzed by Logistic regression according to anxiety or not before surgery evaluated by the State anxiety inventory（20-80，lower is better) . Meanwhile, the prediction model of preoperative anxiety would be established based on independent factors.

  From the 1 day before surgery to 7 days after surgery or discharge, whichever came first

Secondary Outcomes (1)

• Incidence of preoperative anxiety

  The 1 day before surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who met the eligibilty criteria for elective surgery under general anesthesia.

You may qualify if:

• patients undergoing elective with general anesthesia surgery (gynecologic oncology, general surgery, orthopedics and urinary);
• The estimated operation time is more than 2 hours. 3)18≤ age ≤ 80;
• )be able to communicate normally in daily life, without serious hearing and visual impairment; 5)ASA:I-II; 6)sign informed consent and volunteer to participate in this study.

You may not qualify if:

• Having a history of brain diseases, such as stroke, epilepsy, psychosis other history of neuropsychiatry.
• Patients with serious diseases of heart, liver, lung, kidney or other organs.
• Having a definite diagnosis of cognitive impairment, such as Alzheimer's disease;
• Those who use sedatives before evaluation in this study;
• Drug addicts;
• Alcoholics;
• pregnant women;
• participated in other clinical trials as a subject in the past 3 months.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Stomach Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Stomach Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Min Chen

CONTACT

+862168383702; chenmin@renji.com

Siyuan Sun

CONTACT

sunsiyuan@renji.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: October 27, 2022
• Study Start: November 10, 2022
• Primary Completion: October 17, 2023
• Study Completion: March 31, 2024
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

CN (1)