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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03232125
• Other study ID #: 4-2017-0487
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: June 12, 2020

Study information

• Verified date: August 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 12, 2020
• Est. primary completion date: June 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Ramosetron
Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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 Oc — View Citation

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/s12871-016-022 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum change of QTc interval	Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.	Before induction of anesthesia in the supine position (Baseline)
Primary	Maximum change of QTc interval	Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.	10 minutes after tracheal intubation (Intu-10 min.)
Primary	Maximum change of QTc interval	Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.	immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on)
Primary	Maximum change of QTc interval	Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.	30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min)
Primary	Maximum change of QTc interval	Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.	60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min)
Primary	Maximum change of QTc interval	Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.	90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min)
Primary	Maximum change of QTc interval	Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.	immediately after a supine position with CO2 desufflation (T-off)
Primary	Maximum change of QTc interval	Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.	at the end of surgery (Surgery end)