- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02011074
Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Patients Undergoing General Anesthesia
November 17, 2014 updated by: Myung Hee Kim, Samsung Medical Center
Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Psychologically Normal Patients Undergoing General Anesthesia
Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire.
The investigators evaluate the relation of perioperative anxiety and heart rate variability, also the impact of general anesthesia on the change of heart rate variability.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seoul
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Gangnamgu, Seoul, Korea, Republic of, 135-710
- Kim Myunghee
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Hepatocellular carinoma patients undegoing Hepatectomy with general anesthesia
Description
Inclusion Criteria:
- Hepatocellular carcinoma patients
Exclusion Criteria:
- uncontrolled hypertension uncontrolled diabetes mellitus known autonomic nerve dysfunction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Heart rate variability
Time Frame: change from baseline in HRV at 10 minutes after induction of general anesthesia
|
change from baseline in HRV at 10 minutes after induction of general anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
STAI score
Time Frame: change from baseline in HRV at 10 minutes after induction of general anesthesia
|
change from baseline in HRV at 10 minutes after induction of general anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
November 28, 2013
First Submitted That Met QC Criteria
December 9, 2013
First Posted (Estimate)
December 13, 2013
Study Record Updates
Last Update Posted (Estimate)
November 19, 2014
Last Update Submitted That Met QC Criteria
November 17, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-08-043
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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