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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02604979
Other study ID # 4-2015-0607
Secondary ID
Status Completed
Phase N/A
First received October 1, 2015
Last updated January 24, 2017
Start date September 23, 2015
Est. completion date February 6, 2016

Study information

Verified date January 2017
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sympathetic activity could be increased during robot-assisted laparoscopic gastrectomy, which is performed in a head up position under CO2 pneumoperitoneum.

Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias.

Thus the investigators decided to evaluate the heart-rate corrected QT interval (QTc interval) during robotic-assisted laparoscopic gastrectomy.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 6, 2016
Est. primary completion date February 6, 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

1. ASA class I-II

2. obtaining written informed consent from the patients who were undergoing robot- assisted laparoscopic gastrectomy.

Exclusion Criteria:

1. emergency operation

2. cardiac disease (unstable angina, congestive heart failure, valvular heart disease)

3. ventricular conduction abnormality

4. prior pacemaker insertion

5. abnormal electrolyte values

6. patients who take antiarrythmic agent

7. hepatic or renal failure

8. drug hyperactivity

9. neurological or psychiatric illnesses

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the heart-rate corrected QT (QTc) interval (msec) during robotic-assisted laparoscopic gastrectomy (T0: Pre-induction T1: 10min after anesthetic induction T2: 1min after CO2 pneumoperitoneum T3: 5min after CO2 pneumoperitoneum T4: 30min after steep trendelenburg position T5:60min after steep trendelenburg T6: 90min after steep trendelenburg T7: Supine positon following end of pneumoperitoneum T8: 5 min after end of pneumoperitoneum T9: End of surgery T10: 10min after extubation) through study completion, an average of 5 hours
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