Other Specified Injuries of Vocal Cord, SequelaSEVODosageNCT01896245
Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)
A study testing sevoflurane 1,0, sevoflurane 1,2 and sevoflurane 1,4 in people with Other Specified Injuries of Vocal Cord, Sequela, run by University of Rostock at 1 site in Germany.
Trial summary
Anesthesia induction and tracheal intubation can be performed with and without neuromuscular blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are similar, too. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Other Specified Injuries of Vocal Cord, Sequela
- What is being tested?
- sevoflurane 1,0, sevoflurane 1,2 and sevoflurane 1,4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Sep 2014
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ear-nose-throat surgery
- orotracheal intubation for surgery of the ear
- ASA I-III
Who cannot join
- obesity
- allergy against the study drugs
- patients with a known or suspected difficult airway
- diseases of the larynx
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesia and Intensive Care Medicine, University of Rostock
Rostock, Mecklenburg-Vorpommern, 18057
About this study
Anesthesia induction and tracheal intubation can be performed with and without neuromuscular blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are similar, too.
Read the detailed description
We perform tracheal intubation with propofol, remifentanil and sevoflurane; sevoflurane is administered with three dosages. During tracheal intubation intubating conditions are noted. After surgery, all patients are examined by video laryngoscopy; moreover all patients are asked for hoarseness and sore throat.
- Being tested
- sevoflurane 1,0, sevoflurane 1,2, sevoflurane 1,4
- Keywords
- hoarseness, sore throat, intubating conditions, vocal cord injuries, sevoflurane
- Medical subject headings
- Hoarseness, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sevoflurane 1,0Drug
Also called sevo 2,0 %
anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation
sevoflurane 1,2Drug
Also called sevo 2,5 %
anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation
sevoflurane 1,4Drug
Also called sevo 3,0 %
anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane 1,0 | Active comparator | sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC Receives: Drug: sevoflurane 1,0 |
| sevoflurane 1,2 | Active comparator | sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC Receives: Drug: sevoflurane 1,2 |
| sevoflurane 1,4 | Active comparator | sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC Receives: Drug: sevoflurane 1,4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of vocal cord injuries
Measured: 24 hours after tracheal intubation
Secondary outcomes (2)
incidence of hoarseness
Measured: 24, 48, and 72 hours after tracheal intubation
incidence of soar throat
Measured: 24, 48, and 72 hours after tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014
- Study completionSep 2014
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 Other Specified Injuries of Vocal Cord, SequelaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Mencke, University of Rostock
- Investigators
- Thomas Mencke, Dr., Principal investigator, Dep. of Anesthesia and Intensive Care Medicine, University of Rostock, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896245
- Sponsor's protocol ID
- A 2013-0039
- Acronym
- SEVODosage
- Status last verified
- Oct 2014
- First submitted
- 5 Jul 2013
- Last updated
- 6 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ovari A, Bicker I, Machmueller S, Schuldt T, Sauer M, Soltesz S, Noeldge-Schomburg G, Mlynski R, Mencke T. Sevoflurane at 1.0 MAC together with remifentanil and propofol produces clinically acceptable intubation conditions at the vocal cords: A prospective randomized study. J Int Med Res. 2017 Jun;45(3):1098-1108. doi: 10.1177/0300060517701355. Epub 2017 Apr 28.
PubMed 28449630
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Injuries After Anesthesia Induction With Three Different Sevoflurane Concentrations (Without Muscle Relaxant)
- ClinicalTrials.gov ID
- NCT01896245
- Acronym / sponsor ID
- SEVODosage / A 2013-0039
- Keywords
- hoarseness, sore throat, intubating conditions, vocal cord injuries, sevoflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Jul 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.
Anesthesia induction and tracheal intubation can be performed with and without neuromuscular blocking agents (NMBAs). Tracheal intubation can be performed with sevoflurane instead of NMBAs; intubating conditions are similar and the incidence of vocal cord injuries are similar, too.
Detailed description
We perform tracheal intubation with propofol, remifentanil and sevoflurane; sevoflurane is administered with three dosages. During tracheal intubation intubating conditions are noted. After surgery, all patients are examined by video laryngoscopy; moreover all patients are asked for hoarseness and sore throat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sevoflurane 1,0 | Active comparator | Drug: sevoflurane 1,0sevoflurane 1,0: sevoflurane is administered with a concentration of 1,0 MAC |
| sevoflurane 1,2 | Active comparator | Drug: sevoflurane 1,2sevoflurane 1,2: sevoflurane is administered with a concentration of 1,2 MAC |
| sevoflurane 1,4 | Active comparator | Drug: sevoflurane 1,4sevoflurane 1,4: sevoflurane is administered with a concentration of 1,4 MAC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ear-nose-throat surgery
- orotracheal intubation for surgery of the ear
- ASA I-III
Key exclusion criteria (4 listed)
- obesity
- allergy against the study drugs
- patients with a known or suspected difficult airway
- diseases of the larynx
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 |
|---|---|---|
| sevoflurane 1,0Also: sevo 2,0 %anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation | Drug | sevoflurane 1,0 |
| sevoflurane 1,2Also: sevo 2,5 %anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation | Drug | sevoflurane 1,2 |
| sevoflurane 1,4Also: sevo 3,0 %anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation | Drug | sevoflurane 1,4 |
Primary outcome
incidence of vocal cord injuries
Time frame: 24 hours after tracheal intubation
2 secondary outcomes
incidence of hoarseness
Time frame: 24, 48, and 72 hours after tracheal intubation
incidence of soar throat
Time frame: 24, 48, and 72 hours after tracheal intubation
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 6 Oct 2014.
- Derived from this study: PubMed 28449630Ovari A, Bicker I, Machmueller S, Schuldt T, Sauer M, Soltesz S, Noeldge-Schomburg G, Mlynski R, Mencke T. Sevoflurane at 1.0 MAC together with remifentanil and propofol produces clinically acceptable intubation conditions at the vocal cords: A prospective randomized study. J Int Med Res. 2017 Jun;45(3):1098-1108. doi: 10.1177/0300060517701355. Epub 2017 Apr 28.
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.
Thomas Mencke, Dr. principal investigator
Dep. of Anesthesia and Intensive Care Medicine, University of Rostock, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sevoflurane 1,0, sevoflurane 1,2 and sevoflurane 1,4 in people with Other Specified Injuries of Vocal Cord, Sequela, run by University of Rostock at 1 site in Germany.
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 4 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 6 Oct 2014. 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 Germany. 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?
incidence of vocal cord injuries (time frame: 24 hours after tracheal intubation). 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 NCT01896245, 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 6 Oct 2014.