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The aim of the study is to compare anaesthesia (for back surgery) using endotracheal intubation (patients anaesthized in the supine position)with anaesthesia using a laryngeal mask (anaesthesia induced and the laryngeal mask placed with the patient in the prone position on the operation table) as regards advantages, adverse effects and time spent. The anaesthesia in the 2 groups of patients is identical (propofol, remifentanil, rocuronium). Two groups of 70 pt. each are included in the stud. The inclusion criterias are patients 18-70 yrs., ASA group 1-2, normal airways, patients scheduled for back surgery with an estimated duration of less than 2 hours.
Adverse effects (related to the placement on the operation table i.e. pain in the arms or shoulders, pain in the throat, blood in the sputum, irritation in the eyes etc.) and time spent with all the procedures (anaesthesia, placement of the airway, surgery and emergence from the anaesthesia are registered. The hypothesis is that the method using the laryngeal mask is faster and with fewer adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endotracheal group | Active Comparator | airway management: endotracheal tube |
|
| laryngeal mask group | Active Comparator | airway management: laryngeal mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laryngeal mask | Device | LMA Proseal |
| |
| endotracheal tube |
| Measure | Description | Time Frame |
|---|---|---|
| time of anaesthesia | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| adverse effects using the 2 methods | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karsten S Olsen, MD, DMSc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glostrup University Hospital | Glostrup Municipality | DK-2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24247413 | Derived | Olsen KS, Petersen JT, Pedersen NA, Rovsing L. Self-positioning followed by induction of anaesthesia and insertion of a laryngeal mask airway versus endotracheal intubation and subsequent positioning for spinal surgery in the prone position: a randomised clinical trial. Eur J Anaesthesiol. 2014 May;31(5):259-65. doi: 10.1097/EJA.0000000000000004. |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
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| Device |
Unomedical endotracheal tube |
|
| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |