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Clinical Trials/NCT02604979
NCT02604979
Completed
Not Applicable

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

Yonsei University1 site in 1 country30 target enrollmentSeptember 23, 2015
ConditionsStomach Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stomach Cancer
Sponsor
Yonsei University
Enrollment
30
Locations
1
Primary Endpoint
Evaluate the heart-rate corrected QT (QTc) interval (msec) during robotic-assisted laparoscopic gastrectomy
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 23, 2015
End Date
February 6, 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • emergency operation
  • cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
  • ventricular conduction abnormality
  • prior pacemaker insertion
  • abnormal electrolyte values
  • patients who take antiarrythmic agent
  • hepatic or renal failure
  • drug hyperactivity
  • neurological or psychiatric illnesses

Outcomes

Primary Outcomes

Evaluate the heart-rate corrected QT (QTc) interval (msec) during robotic-assisted laparoscopic gastrectomy

Time Frame: 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)

Study Sites (1)

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