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

August 23, 2020 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 03722
        • Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ramosetron group
Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
Placebo Comparator: Placebo group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum change of QTc interval
Time Frame: Before induction of anesthesia in the supine position (Baseline)
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
Time Frame: 10 minutes after tracheal intubation (Intu-10 min.)
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
Time Frame: immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on)
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
Time Frame: 30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min)
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
Time Frame: 60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min)
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
Time Frame: 90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min)
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
Time Frame: immediately after a supine position with CO2 desufflation (T-off)
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
Time Frame: 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.
at the end of surgery (Surgery end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

June 9, 2020

Study Completion (Actual)

June 12, 2020

Study Registration Dates

First Submitted

July 25, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (Actual)

July 27, 2017

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 23, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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