Urinary Tract ProblemPhase 4NCT01303627
Safety of Remifentanil Infusion
A Phase 4 study testing remifentanil in people with Urinary Tract Problem, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Urinary Tract Problem
- What is being tested?
- remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2011to Apr 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-II status
- aged 18-60 years old
- presenting for ureterorenoscopy
Who cannot join
- history of hypertension
- asthma and chronic obstructive lung disease
- recent respiratory tract infections
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of Health Diskapi Yildirim Beyazit Research and Training Hospital departement of 1. Anesthesiology
Ankara, 06110
About this study
Official title: The Effects of Maintenance a Remifentanil Infusion on the Hemodynamic Variables and Recovery Quality
The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated.
Read the detailed description
In all patients (control group and remifentanil group induction of anesthesia will be achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil (1-4 ng/mL) by TCI target controlled infusion, and desflurane . Throughout the surgery hemodynamic parameters are going to be recorded. As soon as the surgery has been finished, in control group remifentanil infusion and desflurane inhalation is going to be stopped.In remifentanil group,desflurane inhalation is going to be stopped and remifentanil infusion will be maintained until the removal of LMA. During the emergence period the time of eye opening, hemodynamic parameters and emergence quality (score 1-2)are going to be recorded.
- Conditions
- Urinary Tract Problem
- Being tested
- remifentanil
- Keywords
- Remifentanil, Laryngeal mask airway removal, Hemodynamic changing, Infusion, Ureterorenoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanilDrug
1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.
| Study group | Role | What they receive |
|---|---|---|
| ultiva,remifentanil,opioid,analgesic | Active comparator | Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery Receives: Drug: remifentanil |
| control | No intervention | Control:Remifentanil stopped at the end of the surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smooth cLMA Removal Condition (Score 1)
cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)
Measured: At the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract ProblemStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya özkan, Diskapi Teaching and Research Hospital
- Investigators
- Jülide Ergil, MD, Study chair, Ministry of Health Dıskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1.Alp Alptekin, MD, Study chair, Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1Nihan Aktürk, MD, Study chair, Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital , Anesthesiology 1Haluk Gümüs, MD, Study chair, Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303627
- Sponsor's protocol ID
- DiskapiTRH
- Status last verified
- Jun 2012
- First submitted
- 24 Feb 2011
- Last updated
- 25 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.
PubMed 19864308
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Maintenance a Remifentanil Infusion on the Hemodynamic Variables and Recovery Quality
- ClinicalTrials.gov ID
- NCT01303627
- Acronym / sponsor ID
- DiskapiTRH
- Conditions
- Urinary Tract Problem
- Keywords
- Remifentanil, Laryngeal mask airway removal, Hemodynamic changing, Infusion, Ureterorenoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Posted 18 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of maintenance remifentanil infusion with target controlled infusion during laryngeal mask airway removal on hemodynamic parameters and emergence quality is going to be investigated.
Detailed description
In all patients (control group and remifentanil group induction of anesthesia will be achieved with desflurane and remifentanil.Anesthesia will be maintained with remifentanil (1-4 ng/mL) by TCI target controlled infusion, and desflurane . Throughout the surgery hemodynamic parameters are going to be recorded. As soon as the surgery has been finished, in control group remifentanil infusion and desflurane inhalation is going to be stopped.In remifentanil group,desflurane inhalation is going to be stopped and remifentanil infusion will be maintained until the removal of LMA. During the emergence period the time of eye opening, hemodynamic parameters and emergence quality (score 1-2)are going to be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultiva,remifentanil,opioid,analgesic | Active comparator | Drug: remifentanilRemifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery |
| control | No intervention | –Control:Remifentanil stopped at the end of the surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-II status
- aged 18-60 years old
- presenting for ureterorenoscopy
Key exclusion criteria (3 listed)
- history of hypertension
- asthma and chronic obstructive lung disease
- recent respiratory tract infections
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 |
|---|---|---|
| remifentanil1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL. | Drug | ultiva,remifentanil,opioid,analgesic |
Primary outcome
Smooth cLMA Removal Condition (Score 1)
Time frame: At the end of the surgery
cLMA removal was accepted as successful (score 1) if none of the complications coughing, teeth clenching, gross purposeful movements, breath holding, laryngospasm, and desatura- tion to SpO2\90% was observed. If any of these compli- cations was observed it was regarded as unsuccessful (score 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19864308Nho JS, Lee SY, Kang JM, Kim MC, Choi YK, Shin OY, Kim DS, Kwon MI. Effects of maintaining a remifentanil infusion on the recovery profiles during emergence from anaesthesia and tracheal extubation. Br J Anaesth. 2009 Dec;103(6):817-21. doi: 10.1093/bja/aep307. Epub 2009 Oct 28.
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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.
Jülide Ergil, MD study chair
Ministry of Health Dıskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1.
Alp Alptekin, MD study chair
Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital, Anesthesiology 1
Nihan Aktürk, MD study chair
Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital , Anesthesiology 1
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing remifentanil in people with Urinary Tract Problem, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 25 Jun 2012. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Smooth cLMA Removal Condition (Score 1) (time frame: At the end of the surgery). 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 NCT01303627, 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 25 Jun 2012.