The Influences of Long Periods of Pneumoperitoneum and Head up Position on the Variation of Heart-rate Corrected QT Interval During Robotic-assisted Laparoscopic Gastrectomy - Observational Study

Stomach Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604979
• Other study ID #: 4-2015-0607
• 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
• 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

Related Conditions & MeSH terms

• Stomach Cancer
• Stomach Neoplasms

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