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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Ramosetron; Drug: Normal saline

• Registration Number: NCT03232125
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-27
• Study Start: 2017-08-01
• Primary Completion: 2020-06-09
• Study Completion: 2020-06-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-23
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ramosetron group	Ramosetron	Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
Placebo group	Normal saline	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 Outcome Measures

Name	Time	Method
Maximum change of QTc interval	at the end of surgery (Surgery end)	Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

Trial Locations

Locations (1)

Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of