Clinical trial NCT03232125: Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position
Official title: Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.
Primary purpose: PREVENTION

Brief summary: Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads to changes in ventricular re-polarization. This in turn can result in changes of heart rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg position.

Detailed description: Intraperitoneal insufflation of carbon dioxide may affect the sympathetic activity that leads to changes in ventricular re-polarization. This in turn can result in changes of heart rate-corrected QT (QTc) interval. Ramosetron is a 5-hydroxytryptamine three receptor antagonist and widely used anti-emetics. However, QTc interval prolongation has been observed in a number of patients after administration of 5-HT3 receptor antagonists. The aim of this study is to evaluate the effects of ramosetron on QTc interval and possible cardiovascular adverse effects during robot-assisted laparoscopic prostatectomy with steep Trendelenburg position. Fifty-six patients, aged more than 19 years, undergoing robot-assisted laparoscopic prostatectomy will be divided into ramosetron group (n=28) and control group (n=28). Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval. The primary endpoint is the difference in maximal change of QTc interval between groups.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing robot-assisted laparoscopic prostatectomy
* Age more than 19 years

Exclusion Criteria:

* Preoperative electrocardiography (ECG) abnormalities, including a QTc interval of \>500 ms, ventricular conduction abnormalities, or arrhythmias
* History of cardiac disease such as pacemaker insertion, unstable angina
* Use of antiarrhythmic agents or medications that are known to prolong the QTc interval
* Abnormal levels of preoperative serum electrolyte

Primary outcomes:
measure: Maximum change of QTc interval
timeFrame: Before induction of anesthesia in the supine position (Baseline)
measure: Maximum change of QTc interval
timeFrame: 10 minutes after tracheal intubation (Intu-10 min.)
measure: Maximum change of QTc interval
timeFrame: immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on)
measure: Maximum change of QTc interval
timeFrame: 30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min)
measure: Maximum change of QTc interval
timeFrame: 60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min)
measure: Maximum change of QTc interval
timeFrame: 90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min)
measure: Maximum change of QTc interval
timeFrame: immediately after a supine position with CO2 desufflation (T-off)
measure: Maximum change of QTc interval
timeFrame: at the end of surgery (Surgery end)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Kim TK, Cho YJ, Lim CW, Min JJ, Choi EK, Hong DM, Jeon Y. Effect of ramosetron on QTc interval: a randomised controlled trial in patients undergoing off-pump coronary artery bypass surgery. BMC Anesthesiol. 2016 Aug 3;16(1):56. doi: 10.1186/s12871-016-0222-1.
citation: Lee JH, Yoo EK, Song IK, Kim JT, Kim HS. Effect of ramosetron on the QT interval during sevoflurane anaesthesia in children: a prospective observational study. Eur J Anaesthesiol. 2015 May;32(5):330-5. doi: 10.1097/EJA.0000000000000200.
citation: Kim SH, Lee SM, Kim YK, Park SY, Lee JH, Cho SH, Chai WS, Jin HC. Effects of prophylactic ramosetron and ondansetron on corrected QT interval during general anesthesia. J Clin Anesth. 2014 Nov;26(7):511-6. doi: 10.1016/j.jclinane.2014.02.011. Epub 2014 Oct 18.