Prostate CancerNCT02536014
Effect of Dexmedetomidine on Heart-rate Corrected QT(QTc) Interval Prolongation During Robotic-assisted Laparoscopic Radical Prostatectomy -Randomized Blind Clinical Trial-
A study testing Dexmedetomidine and Saline in people with Prostate Cancer and Robotic Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
Sympathetic activity could be increased during robot-assisted laparoscopic radical prostatectomy, which is performed in a steep trendelenburg position under CO2 pneumoperitoneum. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Robotic Surgery
- What is being tested?
- Dexmedetomidine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA class I-II
- Otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy
Who cannot join
- Emergency operation
- Cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
- Ventricular conduction abnormality
- Prior pacemaker insertion
- Abnormal electrolyte values
- Patients who take antiarrythmic agent
Show all 9Show fewer
- Hepatic or renal failure
- Drug hyperactivity
- Neurological or psychiatric illnesses
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, Seoul, 03722
About this study
Sympathetic activity could be increased during robot-assisted laparoscopic radical prostatectomy, which is performed in a steep trendelenburg position under CO2 pneumoperitoneum.
Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias.
Dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties. Perioperative administration of dexmedetomidine is a potential preventive and treatment strategy for tachyarrhythmia. Thus the investigators decided to evaluate the effect of dexmedetomidine on heart-rate corrected QT interval during robot-assisted laparoscopic radical prostatectomy. Furthermore, the investigators evaluated the Tp-e, Tp-e/QT ratio and Tp-e/QTc ratio as well.
- Conditions
- Prostate Cancer, Robotic Surgery
- Being tested
- Dexmedetomidine, Saline
- Keywords
- Dexmedetomidine, pneumoperitoneum, trendelenburg position, QTc interval, Tp-e interval, robotic prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine infusion (0.3㎍/kg/hr) from anesthetic induction to the end of pneumoperitoneum
SalineDrug
Saline infusion during the same time period
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Saline | Active comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dexmedetomidine on heart-rate corrected QT(QTc) interval
QTc intervals (msec) are recorded from pre-induction until 60 min after the end of pneumoperitoneum
Measured: From pre-induciton until 60 min after the end of pneumoperitoneum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536014
- Sponsor's protocol ID
- 4-2015-0337
- Status last verified
- Jan 2016
- First submitted
- 14 Jul 2015
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Heart-rate Corrected QT(QTc) Interval Prolongation During Robotic-assisted Laparoscopic Radical Prostatectomy -Randomized Blind Clinical Trial-
- ClinicalTrials.gov ID
- NCT02536014
- Acronym / sponsor ID
- 4-2015-0337
- Conditions
- Prostate Cancer, Robotic Surgery
- Keywords
- Dexmedetomidine, pneumoperitoneum, trendelenburg position, QTc interval, Tp-e interval, robotic prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sympathetic activity could be increased during robot-assisted laparoscopic radical prostatectomy, which is performed in a steep trendelenburg position under CO2 pneumoperitoneum.
Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias.
Dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties. Perioperative administration of dexmedetomidine is a potential preventive and treatment strategy for tachyarrhythmia. Thus the investigators decided to evaluate the effect of dexmedetomidine on heart-rate corrected QT interval during robot-assisted laparoscopic radical prostatectomy. Furthermore, the investigators evaluated the Tp-e, Tp-e/QT ratio and Tp-e/QTc ratio as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine |
| Saline | Active comparator | Drug: Saline |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ASA class I-II
- Otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy
Key exclusion criteria (9 listed)
- Emergency operation
- Cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
- Ventricular conduction abnormality
- Prior pacemaker insertion
- Abnormal electrolyte values
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedetomidine infusion (0.3㎍/kg/hr) from anesthetic induction to the end of pneumoperitoneum | Drug | Dexmedetomidine |
| SalineSaline infusion during the same time period | Drug | Saline |
Primary outcome
Dexmedetomidine on heart-rate corrected QT(QTc) interval
Time frame: From pre-induciton until 60 min after the end of pneumoperitoneum
QTc intervals (msec) are recorded from pre-induction until 60 min after the end of pneumoperitoneum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Saline in people with Prostate Cancer and Robotic Surgery, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dexmedetomidine on heart-rate corrected QT(QTc) interval (time frame: From pre-induciton until 60 min after the end of pneumoperitoneum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.