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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ramosetron
Normal saline
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ramosetron group

Placebo group

Arm 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.

Outcomes

Primary Outcome Measures

Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

Secondary Outcome Measures

Full Information

First Posted
July 25, 2017
Last Updated
August 23, 2020
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03232125
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 9, 2020 (Actual)
Study Completion Date
June 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
Participants, care provider and investigator are blinded to group assignment.
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ramosetron group
Arm Type
Experimental
Arm Description
Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ramosetron
Intervention Description
Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention 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.
Primary Outcome Measure Information:
Title
Maximum change of QTc interval
Description
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Time Frame
Before induction of anesthesia in the supine position (Baseline)
Title
Maximum change of QTc interval
Description
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Time Frame
10 minutes after tracheal intubation (Intu-10 min.)
Title
Maximum change of QTc interval
Description
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Time Frame
immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on)
Title
Maximum change of QTc interval
Description
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Time Frame
30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min)
Title
Maximum change of QTc interval
Description
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Time Frame
60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min)
Title
Maximum change of QTc interval
Description
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Time Frame
90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min)
Title
Maximum change of QTc interval
Description
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Time Frame
immediately after a supine position with CO2 desufflation (T-off)
Title
Maximum change of QTc interval
Description
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Time Frame
at the end of surgery (Surgery end)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27488394
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.
Results Reference
result
PubMed Identifier
25485883
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.
Results Reference
result
PubMed Identifier
25439413
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.
Results Reference
result

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

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