Prostate CancerNCT03232125
Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position
A study testing Ramosetron and Normal saline in people with Prostate Cancer, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ramosetron and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2017to 12 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing robot-assisted laparoscopic prostatectomy
- Age more than 19 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Seoul, 03722
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Ramosetron, Normal saline
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamosetronDrug
Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
Normal salineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Ramosetron group | Experimental | Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. Receives: Drug: Ramosetron |
| Placebo group | Placebo comparator | 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Measured: Before induction of anesthesia in the supine position (Baseline)
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Measured: 10 minutes after tracheal intubation (Intu-10 min.)
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Measured: immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on)
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Measured: 30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min)
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Measured: 60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min)
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Measured: 90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min)
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Measured: immediately after a supine position with CO2 desufflation (T-off)
Maximum change of QTc interval
Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.
Measured: at the end of surgery (Surgery end)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 Aug 2017
- Primary completion9 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232125
- Sponsor's protocol ID
- 4-2017-0487
- Status last verified
- Aug 2020
- First submitted
- 25 Jul 2017
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27488394Lee 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.
PubMed 25485883Kim 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.
PubMed 25439413
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position
- ClinicalTrials.gov ID
- NCT03232125
- Acronym / sponsor ID
- 4-2017-0487
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ramosetron group | Experimental | Drug: RamosetronRandomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. |
| Placebo group | Placebo comparator | Drug: Normal salineIn 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing robot-assisted laparoscopic prostatectomy
- Age more than 19 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamosetronRandomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. | Drug | Ramosetron group |
| Normal salineIn 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. | Drug | Placebo group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Results publication: PubMed 27488394Kim 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 publication: PubMed 25485883Lee 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 publication: PubMed 25439413Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ramosetron and Normal saline in people with Prostate Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum change of QTc interval (time frame: Before induction of anesthesia in the supine position (Baseline)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03232125, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2020.