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NCT Number: NCT03232125

Effect of Ramosetron on Heart Rate-corrected QT Interval 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramosetron

Drug

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

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.

Primary outcomes

  1. Maximum change of QTc interval

    Time frame: Before induction of anesthesia in the supine position (Baseline)

    Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

  2. Maximum change of QTc interval

    Time frame: 10 minutes after tracheal intubation (Intu-10 min.)

    Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

  3. Maximum change of QTc interval

    Time frame: immediately after steep Trendelenburg position with CO2 pneumoperitoneum (T-on)

    Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

  4. Maximum change of QTc interval

    Time frame: 30 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-30 min)

    Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

  5. Maximum change of QTc interval

    Time frame: 60 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-60 min)

    Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

  6. Maximum change of QTc interval

    Time frame: 90 minutes after steep Trendelenburg position with CO2 pneumoperitoneum (T-90 min)

    Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

  7. Maximum change of QTc interval

    Time frame: immediately after a supine position with CO2 desufflation (T-off)

    Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

  8. Maximum change of QTc interval

    Time frame: at the end of surgery (Surgery end)

    Maximum change of QTc interval from continuous ECG monitoring in lead V5 were collected by using the LabChart software.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2017
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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