Anxiety Before Non-cardiac Surgery in Adults

Recruiting

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

• Registration Number: NCT05596188
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-27
• Study Start: 2022-11-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-05-31
• Primary Completion: 2023-10-17
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

1. patients undergoing elective with general anesthesia surgery (gynecologic oncology, general surgery, orthopedics and urinary);
2. The estimated operation time is more than 2 hours. 3)18≤ age ≤ 80;

4)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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Independent risk factors of preoperative anxiety and establishment of prediction model	From the 1 day before surgery to 7 days after surgery or discharge, whichever came first	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of preoperative anxiety	The 1 day before surgery	The State anxiety inventory (20-80，lower is better) was used to investigate the incidence of Preoperative anxiety

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, China