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Trial record 29 of 30 for:    prostate cancer prevention | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT03232125
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : October 16, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Ramosetron Drug: Normal saline Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator)
Masking Description: Participants, care provider and investigator are blinded to group assignment.
Primary Purpose: Prevention
Official Title: Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ramosetron group
Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
Drug: Ramosetron
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.
Drug: 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232125


Contacts
Contact: Seung Ho Choi, MD, Ph.D 82-2-2228-2427 csho99@yuhs.ac

Locations
Korea, Republic of
Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Seung Ho Choi, MD, Ph.D    82-2-2228-2427    csho99@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Publications of Results:
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03232125     History of Changes
Other Study ID Numbers: 4-2017-0487
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ramosetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action