Stomach Cancer Clinical Trial
Verified date | January 2017 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
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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