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

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.

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Key information

Conditions

Stomach Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 16, 2015
Registry last updated: Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed