Condition category
Surgery
Date applied
14/11/2020
Date assigned
18/11/2020
Last edited
17/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Patients in hospital who are about to undergo surgery tend to be nervous and anxious. The aim of this study is to compare the psychological effects of preoperative anxiety on anaesthesia recovery in patients undergoing varicose great saphenous vein surgery under general anesthesia.

Who can participate?
Patients between the ages of 18 and 65 years with varicose great saphenous vein undergoing general anesthesia and elective surgery in Shanghai East Hospital.

What does the study involve?
The participants are interviewed when they come to the anesthesia clinic for a preoperative examination under the instruction of an anesthesiologist. The participants answer questions about their anxiety regarding the anesthesia and surgery. The researchers also record characteristics including gender, age, height, weight, degree, and history of general anesthesia surgery.

What are the possible benefits and risks of participating?
Participating may benefit patients in the future. Participants may need to undergo more physical examinations, communicate with the doctor frequently, or receive hospital care. This may take more time and effort.

Where is the study run from?
Tongji University School of Medicine (China)

When is the study starting and how long is it expected to run for?
May 2019 to February 2020

Who is funding the study?
Shanghai East Hospital (China)

Who is the main contact?
Hui Wang
huihuismile@126.com

Trial website

Contact information

Type

Public

Primary contact

Miss Hui Wang

ORCID ID

http://orcid.org/0000-0002-4185-0234

Contact details

150 Jimo Road
Pudong New Area
Shanghai
200120
China
+86 (0)18321806626
huihuismile@126.com

Additional identifiers

EudraCT number

2020-005453-24

ClinicalTrials.gov number

Nil known

Protocol/serial number

2019 研预审第(067)号

Study information

Scientific title

The midbrain ventral tegmental area is essential for delayed awakening from general anesthesia of anxiety state: in vivo and in vitro

Acronym

Study hypothesis

Preoperative anxiety state can induce adverse outcomes in surgical patients.

Ethics approval

Approved 11/05/2019, Shanghai East Hospital Medical Ethics Committee (150 Jimo Road, Pudong New Area, Shanghai, China; +86 (0)21 61569829; qxw1123@126.com), ref: not applicable

Study design

Single-centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Patients with varicose great saphenous vein who received general anesthesia and elective surgery

Intervention

The participants are interviewed when they come to the anesthesia clinic for preoperative examination under the instruction of an anesthesiologist. The participants are asked to sit on a chair and answer the questions of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anxiety scores are evaluated by calculating the scores for the six statements of the APAIS. Anxiety score is obtained by calculating the total scores assigned to the expressions “ I am worried about the anesthetic”, “The anesthetic is on my mind continually”, “I would like to know as much as possible about the anesthetic”, “I am worried about the procedure”, “The procedure is on my mind continually”, “I would like to know as much as possible about the procedure” to measure the patient’s level of anxiety regarding the anesthesia and surgery. Higher scores suggest a higher grade of anxiety. The researchers also record demographic characteristics, including gender, age, height, weight, degree, and history of general anesthesia surgery. The study visit and postoperative extubation procedure are performed by two different anesthesiologists.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Extubation time, defined as the time between drug withdrawal and the time at which a BIS greater than or equal to 85 was achieved and the tube could be removed

Secondary outcome measures

1. Post-anesthesia anesthesia recovery measured using Alderte score every 15 min in the post-anesthesia recovery room (PACU)
2. Postoperative pain visual analog scale (VAS) scores at 6 h, 12 h, and 24 h
3. Postoperative nausea and vomiting VAS scores at 6 h, 12 h, and 24 h
4. Postoperative restlessness measured using sedative and agitation scale (SAS) at 5, 10, 15 and 20 min after entering the PACU
5. Chills measured using postoperative shiver score at 5, 10, 15 and 20 min after entering the PACU
6. Operation length, measured as the time interval from the initiation to the end of surgery
7. Anesthesia length, measured as the time interval from the initiation of anesthesia to the end of surgery
8. Length of hospital stay, measured as discharge date minus admission day plus one

Overall trial start date

11/05/2019

Overall trial end date

25/02/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

18-65-year-old patients with varicose great saphenous vein who received general anesthesia and elective surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

82

Total final enrolment

82

Participant exclusion criteria

1. Psychiatric disorders
2. Alzheimer's disease
3. Mental retardation
4. Cardiopulmonary severe dysfunction
5. Liver and kidney dysfunction
6. History of drug or alcohol abuse
7. ASA III-IV patients

Recruitment start date

01/08/2019

Recruitment end date

25/02/2020

Locations

Countries of recruitment

China

Trial participating centre

Tongji University School of Medicine
Department of Anesthesiology East Hospital 150 Jimo Road Pudong New Area
Shanghai
200120
China

Sponsor information

Organisation

Tongji University

Sponsor details

School of Medicine
Department of Anesthesiology
East Hospital
150 Jimo Road
Pudong New Area
Shanghai
200120
China
+86 (0)13310054121
qxw1123@126.com

Sponsor type

University/education

Website

http://www.easthospital.cn/

Funders

Funder type

Hospital/treatment centre

Funder name

Shanghai East Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Hui Wang (huihuismile@126.com).

Intention to publish date

31/03/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/11/2020: Trial's existence confirmed by Shanghai East Hospital Medical Ethics Committee.