Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Ramosetron
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ramosetron group<br>Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. | Drug: Ramosetron<br>* Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.<br>|
| Placebo Comparator: Placebo group<br>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. | Drug: Normal saline<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum change of QTc interval | Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software. | Before induction of anesthesia in the supine position (Baseline) | 
| Maximum change of QTc interval | Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software. | 10 minutes after tracheal intubation (Intu-10 min.) | 
| Maximum change of QTc interval | Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software. | immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on) | 
| Maximum change of QTc interval | Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software. | 30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min) | 
| Maximum change of QTc interval | Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software. | 60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min) | 
| Maximum change of QTc interval | Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software. | 90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min) | 
| Maximum change of QTc interval | Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software. | immediately after a supine position with CO2 desufflation (T-off) | 
| Maximum change of QTc interval | Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software. | at the end of surgery (Surgery end) |