NCT03232125

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

2.9 years

First QC Date

July 25, 2017

Last Update Submit

August 23, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (8)

  • 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)

  • 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)

Study Arms (2)

Ramosetron group

EXPERIMENTAL

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

Drug: Ramosetron

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.

Drug: Normal saline

Interventions

RamosetronDRUG

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

Ramosetron group
Normal salineDRUG

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.

Placebo group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing robot-assisted laparoscopic prostatectomy
  • Age more than 19 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professor, Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 27488394RESULT

  • 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.

    PMID: 25485883RESULT

  • 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.

    PMID: 25439413RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

ramosetronSaline Solution

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Participants, care provider and investigator are blinded to group assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 27, 2017

Study Start

August 1, 2017

Primary Completion

June 9, 2020

Study Completion

June 12, 2020

Last Updated

August 25, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)