Vocal Cord; Injury, SuperficialNCT01616966
Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol
A study testing Sevoflurane and propofol in people with Vocal Cord; Injury, Superficial, run by University of Rostock at 1 site in Germany.
Trial summary
Vocal cord injuries occur not only during tracheal intubation, but also during surgery and during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle relaxants. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vocal Cord; Injury, Superficial
- What is being tested?
- Sevoflurane and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Oct 2011
- 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
- orotracheal intubation
- surgery of the ear
- written consent
- ASA I-III
Who cannot join
- preexisting pathologies of the vocal cords
- obesity
- difficult airway
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Anesthesia With Sevoflurane and Intravenous Anesthesia With Propofol A Randomized, Prospective, Controlled Trial
Vocal cord injuries occur not only during tracheal intubation, but also during surgery and during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less vocal cord injuries than a total intravenous anesthesia with propofol.
Read the detailed description
Volatile anaesthetics increase neuromuscular block of neuromuscular blocking drugs. We tested the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous anaesthesia with propofol. Sixty five patients were randomly assigned to the SEVO group (anaesthesia with sevoflurane) or TIVA group (anaesthesia with propofol). Vocal cord injuries were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness was assessed up to 72 h.
- Conditions
- Vocal Cord; Injury, Superficial
- Being tested
- Sevoflurane, propofol
- Keywords
- hoarseness, sore throat, vocal cord injuries
- Medical subject headings
- Wounds and Injuries, Hoarseness, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called remifentanil
Maintenance of anesthesia with sevoflurane 1.0 Vol%
propofolDrug
Also called remifentanil
Maintenance of anesthesia with propofol
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Active comparator | Anesthesia was maintained with sevoflurane during surgery. Receives: Drug: Sevoflurane |
| Anesthesia with propofol | Active comparator | Anesthesia was maintained with propofol during surgery. Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of vocal cord injuries
assessed by stroboscopy
Measured: 24h after surgery
Secondary outcomes (1)
incidence of hoarseness
Measured: 24h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startAug 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord; Injury, SuperficialStudies 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
- 65 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616966
- Sponsor's protocol ID
- A 2010 29
- Status last verified
- Jun 2012
- First submitted
- 7 Jun 2012
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Anesthesia With Sevoflurane and Intravenous Anesthesia With Propofol A Randomized, Prospective, Controlled Trial
- ClinicalTrials.gov ID
- NCT01616966
- Acronym / sponsor ID
- A 2010 29
- Conditions
- Vocal Cord; Injury, Superficial
- Keywords
- hoarseness, sore throat, vocal cord injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Jun 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.
Vocal cord injuries occur not only during tracheal intubation, but also during surgery and during removal of tracheal tube. Volatile anesthetics increase neuromuscular block of muscle relaxants. Thus, the investigators tested the hypothesis, that sevoflurane would cause less vocal cord injuries than a total intravenous anesthesia with propofol.
Detailed description
Volatile anaesthetics increase neuromuscular block of neuromuscular blocking drugs. We tested the hypothesis, that sevoflurane would cause less vocal cord injuries than an intravenous anaesthesia with propofol. Sixty five patients were randomly assigned to the SEVO group (anaesthesia with sevoflurane) or TIVA group (anaesthesia with propofol). Vocal cord injuries were examined by stroboscopy before and 24 and 72 h after surgery; hoarseness was assessed up to 72 h.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Active comparator | Drug: SevofluraneAnesthesia was maintained with sevoflurane during surgery. |
| Anesthesia with propofol | Active comparator | Drug: propofolAnesthesia was maintained with propofol during surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- orotracheal intubation
- surgery of the ear
- written consent
- ASA I-III
Key exclusion criteria (3 listed)
- preexisting pathologies of the vocal cords
- obesity
- difficult airway
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: remifentanilMaintenance of anesthesia with sevoflurane 1.0 Vol% | Drug | Sevoflurane |
| propofolAlso: remifentanilMaintenance of anesthesia with propofol | Drug | Anesthesia with propofol |
Primary outcome
incidence of vocal cord injuries
Time frame: 24h after surgery
assessed by stroboscopy
1 secondary outcome
incidence of hoarseness
Time frame: 24h after surgery
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 3 Jul 2012.
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 Sevoflurane and propofol in people with Vocal Cord; Injury, Superficial, 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 4 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 3 Jul 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 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: 24h after surgery). 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 3 Jul 2012.