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
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2015
CompletedFirst Submitted
Initial submission to the registry
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2016
CompletedJanuary 25, 2017
January 1, 2017
5 months
October 1, 2015
January 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
Patients who were undergoing robot- assited laparoscopic gastrectomy
You may qualify if:
- ASA class I-II
- obtaining written informed consent from the patients who were undergoing robot- assisted laparoscopic gastrectomy.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Seoul, 03722, South Korea
Related Publications (1)
Kim NY, Bai SJ, Kim HI, Hong JH, Nam HJ, Koh JC, Kim HJ. Effects of long periods of pneumoperitoneum combined with the head-up position on heart rate-corrected QT interval during robotic gastrectomy: an observational study. J Int Med Res. 2018 Nov;46(11):4586-4595. doi: 10.1177/0300060518786914. Epub 2018 Jul 20.
PMID: 30027782DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2015
First Posted
November 16, 2015
Study Start
September 23, 2015
Primary Completion
February 6, 2016
Study Completion
February 6, 2016
Last Updated
January 25, 2017
Record last verified: 2017-01