Coughing on InductionPhase 4NCT01792063
Two Different Preparations of Sevoflurane in Induction
A Phase 4 study testing Sevoflurane in people with Coughing on Induction and Vapors; Inhalation, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity rapid inhalation induction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coughing on Induction, Vapors; Inhalation
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Apr 2013
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing abdominal surgery
Who cannot join
- Patients with any cardiovascular or respiratory disease, usage of any kind of sedative drug, expected airway difficulty and obese patients (BMI>35) will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Istanbul, Fatih, 34400
About this study
Official title: A Randomized Clinical Trial on the Efficiency, Hemodynamic Effects and Patient Comfort of Two Different Preparations of Sevoflurane After Vital Capacity Rapid Inhalation Induction
In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity rapid inhalation induction.
- Conditions
- Coughing on Induction, Vapors; Inhalation
- Being tested
- Sevoflurane
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Sevorane, Abbott Laboratories
SevofluraneDrug
Also called Sojourn, Adeka IS A.S
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane A | Active comparator | Generic sevoflurane Receives: Drug: Sevoflurane |
| Sevoflurane B | Active comparator | Orginal sevoflurane Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of different preparations of sevoflurane on Induction on hypnosis time
Induction for anesthesia will be achieved with sevoflurane A and Sevoflurane B in total of 100 randomized (American Society of Anesthesiology status I-II) patients undergoing abdominal surgery. During the induction patients will be asked to breath as deep as possible and then hold their breaths to the point where they cannot anymore and flexing their right arm. Occurrence of hypnosis will be confirmed with both the loss of eyelash-reflex and failing of flexed-holding arm. Time and number of breaths needed for the loss of consciousness will be noted. Existence of hiccup, cough, increase in secretions, and refusal of the mask by the patient will be reported if any. All patients will be extubated and released to the ward after they are questioned about any discomfort or issue they want to report to anesthesiologist
Measured: 1 hour
Secondary outcomes (1)
effect of different sevoflurane preparations on hemodynamics
After the induction and occurrence of hypnosis, Systemic arterial pressure (SAP) values will be noted. Tracheal intubation will be performed and post-intubation SAP values will be noted. The SAP values will noted in the 5th minute of the induction.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionApr 2013
- Study completionApr 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 Coughing on InductionStudies of the same condition, open and under way.
- More trials run by Istanbul 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792063
- Sponsor's protocol ID
- 43430
- Status last verified
- Apr 2013
- First submitted
- 12 Feb 2013
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baker MT. Sevoflurane: are there differences in products? Anesth Analg. 2007 Jun;104(6):1447-51, table of contents. doi: 10.1213/01.ane.0000263031.96011.36.
PubMed 17513639
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial on the Efficiency, Hemodynamic Effects and Patient Comfort of Two Different Preparations of Sevoflurane After Vital Capacity Rapid Inhalation Induction
- ClinicalTrials.gov ID
- NCT01792063
- Acronym / sponsor ID
- 43430
- Conditions
- Coughing on Induction, Vapors; Inhalation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Feb 2013 (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.
In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity rapid inhalation induction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane A | Active comparator | Drug: SevofluraneGeneric sevoflurane |
| Sevoflurane B | Active comparator | Drug: SevofluraneOrginal sevoflurane |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing abdominal surgery
Key exclusion criteria (1 listed)
- Patients with any cardiovascular or respiratory disease, usage of any kind of sedative drug, expected airway difficulty and obese patients (BMI>35) will be excluded from the study
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 |
|---|---|---|
| SevofluraneAlso: Sevorane, Abbott Laboratories | Drug | Sevoflurane A |
| SevofluraneAlso: Sojourn, Adeka IS A.S | Drug | Sevoflurane B |
Primary outcome
effect of different preparations of sevoflurane on Induction on hypnosis time
Time frame: 1 hour
Induction for anesthesia will be achieved with sevoflurane A and Sevoflurane B in total of 100 randomized (American Society of Anesthesiology status I-II) patients undergoing abdominal surgery. During the induction patients will be asked to breath as deep as possible and then hold their breaths to the point where they cannot anymore and flexing their right arm. Occurrence of hypnosis will be confirmed with both the loss of eyelash-reflex and failing of flexed-holding arm. Time and number of breaths needed for the loss of consciousness will be noted. Existence of hiccup, cough, increase in secretions, and refusal of the mask by the patient will be reported if any. All patients will be extubated and released to the ward after they are questioned about any discomfort or issue they want to report to anesthesiologist
1 secondary outcome
effect of different sevoflurane preparations on hemodynamics
Time frame: 1 hour
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 19 Apr 2013.
- Background: PubMed 17513639Baker MT. Sevoflurane: are there differences in products? Anesth Analg. 2007 Jun;104(6):1447-51, table of contents. doi: 10.1213/01.ane.0000263031.96011.36.
Related trials for Coughing on Induction
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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 Phase 4 study testing Sevoflurane in people with Coughing on Induction and Vapors; Inhalation, run by Istanbul University 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 1 inclusion and 1 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 19 Apr 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 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?
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?
effect of different preparations of sevoflurane on Induction on hypnosis time (time frame: 1 hour). 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 NCT01792063, 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 19 Apr 2013.