Prostate Cancer
Conditions
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.
Interventions
DRUGRamosetron
Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
DRUGNormal 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Participants, care provider and investigator are blinded to group 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum change of QTc interval | 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. |
Countries
South Korea
Outcome results
None listed