- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03232125
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
Intervention / Treatment
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
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Seoul, Korea, Republic of, 03722
- Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
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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.
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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)
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Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
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Before induction of anesthesia in the supine position (Baseline)
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Maximum change of QTc interval
Time Frame: 10 minutes after tracheal intubation (Intu-10 min.)
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Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
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10 minutes after tracheal intubation (Intu-10 min.)
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Maximum change of QTc interval
Time Frame: immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on)
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Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
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immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on)
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Maximum change of QTc interval
Time Frame: 30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min)
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Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
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30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min)
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Maximum change of QTc interval
Time Frame: 60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min)
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Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
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60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min)
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Maximum change of QTc interval
Time Frame: 90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min)
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Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
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90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min)
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Maximum change of QTc interval
Time Frame: immediately after a supine position with CO2 desufflation (T-off)
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Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
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immediately after a supine position with CO2 desufflation (T-off)
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Maximum change of QTc interval
Time Frame: at the end of surgery (Surgery end)
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Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
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at the end of surgery (Surgery end)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Serotonin Agents
- Serotonin Antagonists
- Ramosetron
Other Study ID Numbers
- 4-2017-0487
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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