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

Completed

• Conditions: Stomach Cancer

• Registration Number: NCT02604979
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-23
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-11-11
• Study First Posted: 2015-11-16
• Primary Completion: 2016-02-06
• Study Completion: 2016-02-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. ASA class I-II
2. obtaining written informed consent from the patients who were undergoing robot- assisted laparoscopic gastrectomy.

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the heart-rate corrected QT (QTc) interval (msec) during robotic-assisted laparoscopic gastrectomy	through study completion, an average of 5 hours	(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)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of