Anesthesia, GeneralNCT01650961
The Effect of Palonosetron on the QTc Interval During Perioperative Period
A study testing Palonosetron and Normal saline in people with Anesthesia, General and Palonosetron, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Anesthesia, General, Palonosetron
- What is being tested?
- Palonosetron and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Feb 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective abdominal surgery under general anesthesia
Who cannot join
- Cardiac valvular disease
- Clinically significant arrhythmias including atrial fibrillation
- Anti-emetics within 24 hours before surgery
- Steroids within 1 week before surgery
- Cancer chemotherapy or radiotherapy within 4 weeks before surgery
- Diabetes mellitus
- Pregnancy
- Patients receives a QT-prolonging drug
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.
- Conditions
- Anesthesia, General, Palonosetron
- Being tested
- Palonosetron, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalonosetronDrug
Also called Aloxi
0.075 mg IV as bolus before induction of general anesthesia
Normal salineDrug
2 ml normal saline as bolus before induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Palonosetron | Experimental | Intravenous administration of palonosetron 0.075 mg before the induction of general anesthesia Receives: Drug: Palonosetron |
| Control | Placebo comparator | Intravenous administration of normal saline before the induction of general anesthesia Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
corrected QT interval (QTc interval)
at 2, 10, 15, 30, 60, 90 minutes after induction of general anesthesia, up to 1 minute after tracheal intubation
Measured: up to 90 minutes after induction of general anesthesia
Secondary outcomes (4)
proportion of patients whose corrected QT interval (QTc interval) is more than 450 ms for male or 470 ms for female
Measured: up to 2 hours after induction of general anesthesia
corrected QT interval (QTc interval) at Postanesthetic care unit
Measured: up to 1 hour after arrival on postanesthetic care unit
Incidence of postoperative nausea and vomiting
Measured: for 24 hours after surgery
proportion of patients who have more than 500 ms of corrected QT interval (QTc interval)
Measured: up to 2 hours after induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650961
- Sponsor's protocol ID
- YSJeon_palonosetron_QTc
- Status last verified
- Aug 2013
- First submitted
- 24 Jul 2012
- Last updated
- 7 Aug 2013
- Results posted
- No
Publications
Kim HJ, Lee HC, Jung YS, Lee J, Min JJ, Hong DM, Choi EK, Oh S, Jeon Y. Effect of palonosetron on the QTc interval in patients undergoing sevoflurane anaesthesia. Br J Anaesth. 2014 Mar;112(3):460-8. doi: 10.1093/bja/aet335. Epub 2013 Oct 14.
PubMed 24129597
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Palonosetron on the QTc Interval During Perioperative Period
- ClinicalTrials.gov ID
- NCT01650961
- Acronym / sponsor ID
- YSJeon_palonosetron_QTc
- Conditions
- Anesthesia, General, Palonosetron
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 26 Jul 2012 (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.
The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palonosetron | Experimental | Drug: PalonosetronIntravenous administration of palonosetron 0.075 mg before the induction of general anesthesia |
| Control | Placebo comparator | Drug: Normal salineIntravenous administration of normal saline before the induction of general anesthesia |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective abdominal surgery under general anesthesia
Key exclusion criteria (8 listed)
- Cardiac valvular disease
- Clinically significant arrhythmias including atrial fibrillation
- Anti-emetics within 24 hours before surgery
- Steroids within 1 week before surgery
- Cancer chemotherapy or radiotherapy within 4 weeks before surgery
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 |
|---|---|---|
| PalonosetronAlso: Aloxi0.075 mg IV as bolus before induction of general anesthesia | Drug | Palonosetron |
| Normal saline2 ml normal saline as bolus before induction of general anesthesia | Drug | Control |
Primary outcome
corrected QT interval (QTc interval)
Time frame: up to 90 minutes after induction of general anesthesia
at 2, 10, 15, 30, 60, 90 minutes after induction of general anesthesia, up to 1 minute after tracheal intubation
4 secondary outcomes
proportion of patients whose corrected QT interval (QTc interval) is more than 450 ms for male or 470 ms for female
Time frame: up to 2 hours after induction of general anesthesia
corrected QT interval (QTc interval) at Postanesthetic care unit
Time frame: up to 1 hour after arrival on postanesthetic care unit
Incidence of postoperative nausea and vomiting
Time frame: for 24 hours after surgery
proportion of patients who have more than 500 ms of corrected QT interval (QTc interval)
Time frame: up to 2 hours after induction of general anesthesia
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 7 Aug 2013.
- Derived from this study: PubMed 24129597Kim HJ, Lee HC, Jung YS, Lee J, Min JJ, Hong DM, Choi EK, Oh S, Jeon Y. Effect of palonosetron on the QTc interval in patients undergoing sevoflurane anaesthesia. Br J Anaesth. 2014 Mar;112(3):460-8. doi: 10.1093/bja/aet335. Epub 2013 Oct 14.
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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 Palonosetron and Normal saline in people with Anesthesia, General and Palonosetron, run by Seoul National University Hospital 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 1 inclusion and 8 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 7 Aug 2013. 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. Some participants in this study may receive a placebo. 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?
corrected QT interval (QTc interval) (time frame: up to 90 minutes after induction of general anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01650961, which also lists 1 linked publication.
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 7 Aug 2013.