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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramosetron group | Experimental | Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramosetron | Drug | Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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.) |
| 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) |
| 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) |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27488394 | Result | 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. | |
| 25485883 | Result | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C071315 | ramosetron |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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.
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Participants, care provider and investigator are blinded to group assignment.
| Normal saline | Drug | 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. | 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. | at the end of surgery (Surgery end) |
| 25439413 | Result | 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 Oct 18. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |