An interventional study of Ramosetron and Normal saline in Prostate Cancer, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-08-25.
Sponsored by Yonsei University · Not applicable, Interventional, and Prevention
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.
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.
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This study's enrollment of 54 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
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Exclusion Criteria:
Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
Drug: Ramosetron
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
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.
Maximum change of QTc interval
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)
Maximum change of QTc interval
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.)
Maximum change of QTc interval
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)
Maximum change of QTc interval
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)
Maximum change of QTc interval
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)
Maximum change of QTc interval
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)
Maximum change of QTc interval
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)
Maximum change of QTc interval
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)
Plan to share: No
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Yonsei University