Laryngeal Injuries After Removal of the Tracheal Tube: A Comparison Between Sevoflurane and Propofol
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Vocal Cord; Injury, Superficial |
Drug: Sevoflurane Drug: propofol |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
- incidence of vocal cord injuries [ Time Frame: 24h after surgery ] [ Designated as safety issue: No ]assessed by stroboscopy
- incidence of hoarseness [ Time Frame: 24h after surgery ] [ Designated as safety issue: No ]
| Enrollment: | 65 |
| Study Start Date: | August 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sevoflurane
Anesthesia was maintained with sevoflurane during surgery.
|
Drug: Sevoflurane
Maintenance of anesthesia with sevoflurane 1.0 Vol%
Other Name: remifentanil
|
|
Active Comparator: Anesthesia with propofol
Anesthesia was maintained with propofol during surgery.
|
Drug: propofol
Maintenance of anesthesia with propofol
Other Name: remifentanil
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- orotracheal intubation
- surgery of the ear
- written consent
- ASA I-III
Exclusion Criteria:
- preexisting pathologies of the vocal cords
- obesity
- difficult airway
Contacts and Locations More Information
No publications provided
| Responsible Party: | Thomas Mencke, University of Rostock |
| ClinicalTrials.gov Identifier: | NCT01616966 History of Changes |
| Other Study ID Numbers: | A 2010 29 |
| Study First Received: | June 7, 2012 |
| Last Updated: | June 29, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Rostock:
|
hoarseness sore throat vocal cord injuries |
Additional relevant MeSH terms:
|
Anesthetics Propofol Sevoflurane Remifentanil Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Intravenous |
Anesthetics, General Hypnotics and Sedatives Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013