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

Yonsei University

Status: Completed

Conditions: Prostate Cancer

Treatments: Drug: Ramosetron; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03232125

4-2017-0487

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups, including a placebo group

Ramosetron group

Experimental group

Description:

Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.

Treatment:

Drug: Ramosetron

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal saline