Clinical trial · Interventional
Effect of Ramosetron on Heart Rate-corrected QT Interval During Robot-assisted Laparoscopic Prostatectomy With Steep Trendelenburg Position
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Normal saline | Drug | — | UNRESOLVED |
| Ramosetron | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ramosetron group
- description
- Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
- interventionNames
- Drug: Ramosetron
- type
- PLACEBO_COMPARATOR
- label
- Placebo group
- description
- 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.
- interventionNames
- Drug: Normal saline
Primary outcomes (8)
- measure
- Maximum change of QTc interval
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTKim 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. PMID 27488394
- RESULTLee 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. PMID 25485883
- RESULTKim 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. PMID 25439413