The effect of anxiety before surgery on recovery from anesthesia

ISRCTN ISRCTN18373253
DOI https://doi.org/10.1186/ISRCTN18373253
EudraCT/CTIS number 2020-005453-24
Secondary identifying numbers 2019 研预审第(067)号
Submission date
14/11/2020
Registration date
18/11/2020
Last edited
17/11/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Miss Hui Wang
Public

150 Jimo Road
Pudong New Area
Shanghai
200120
China

ORCiD logoORCID ID 0000-0002-4185-0234
Phone +86 (0)18321806626
Email huihuismile@126.com

Study information

Study designSingle-centre observational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe midbrain ventral tegmental area is essential for delayed awakening from general anesthesia of anxiety state: in vivo and in vitro
Study objectivesPreoperative anxiety state can induce adverse outcomes in surgical patients.
Ethics approval(s)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
Health condition(s) or problem(s) studiedPatients with varicose great saphenous vein who received general anesthesia and elective surgery
InterventionThe 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 typeOther
Primary outcome measureExtubation 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 measures1. 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 study start date11/05/2019
Completion date25/02/2020

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants82
Total final enrolment82
Key inclusion criteria18-65-year-old patients with varicose great saphenous vein who received general anesthesia and elective surgery
Key exclusion criteria1. 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
Date of first enrolment01/08/2019
Date of final enrolment25/02/2020

Locations

Countries of recruitment

  • China

Study participating centre

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

Sponsor information

Tongji University
University/education

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

Phone +86 (0)13310054121
Email qxw1123@126.com
Website http://www.easthospital.cn/
ROR logo "ROR" https://ror.org/03rc6as71

Funders

Funder type

Hospital/treatment centre

Shanghai East Hospital

No information available

Results and Publications

Intention to publish date31/03/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Hui Wang (huihuismile@126.com).

Editorial Notes

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