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
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