Airway Management in Children Undergoing Adenotonsillectomies
Raktažodžiai
Santrauka
apibūdinimas
Registration:
Preoperative: Age, height, weight, medication, asthma/allergy, possible current respiratory infection
Peroperative: Type of procedure, tube size/laryngeal mask, type of tongue blade, highest/lowest SpO2, highest/lowest ET CO2, highest/lowest pulse, length of surgery, total operating room time, operator, medication. Reason must be given if converting from laryngeal mask to tube; lack of visibility for operator, laryngeal mask not possible to place, unacceptable leakage before placing tongue blade, occlusion after placement of tongue blade.
Postoperative: Pain judged by need for opiates (VAS, crying, agitation, tachycardia), nausea judged by gagging/vomiting, total time in recovery, rebleeding judged by reoperation.
Anesthesia:
Induction: Alfentanil 20 microg/kg body weight Propofol 3-4 mg/kg body weight Or: Sevoflurane/N2O mask induction with MAC 1-2
Maintenance: Alfentanil 5-10 microg/kg body weight every 8-10 minutes Sevoflurane/N2O equivalent to 1-1.5 MAC Acetaminophen supp 40 mg/kg body weight, max 2 g. Dexamethasone 0.15mg/kg body weight Xylocaine 1mg/kg body weight
Emergence: Morphine 100-200 mikrog/kg body weight
Postoperative: Morphine 50-100 microg/kg body weight
Post-discharge: Acetaminophen tbl 15 mg/kg body weight x 3 Or: Acetaminophen supp 20 mg/kg body weight x 3
Patient booklet:
A patient booklet will be produced for each patient. The booklet will contain only the patient's initials, age and research number. After the booklets are filled out, they will be stored in a locked facility by one of the examining physicians, and the code to the patient's name will be stored and locked separately by one of the researchers. The code will be destroyed at the end of the research study.
Datos
Paskutinį kartą patikrinta: | 12/31/2008 |
Pirmasis pateikimas: | 12/09/2007 |
Numatytas registravimas pateiktas: | 12/09/2007 |
Pirmas paskelbtas: | 12/10/2007 |
Paskutinis atnaujinimas pateiktas: | 01/13/2009 |
Paskutinis atnaujinimas paskelbtas: | 01/14/2009 |
Faktinė studijų pradžios data: | 02/28/2007 |
Numatoma pirminio užbaigimo data: | 07/31/2008 |
Numatoma studijų užbaigimo data: | 07/31/2008 |
Būklė ar liga
Intervencija / gydymas
Device: 1
Device: 2
Fazė
Rankų grupės
Ranka | Intervencija / gydymas |
---|---|
Active Comparator: 1 Laryngeal mask airway (LMA) | Device: 1 Airway management by the use of the flexible, reinforced laryngeal mask airway |
Active Comparator: 2 Endotracheal tube (ETT) | Device: 2 Airway management by the use of endotracheal tube |
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 3 Years Į 3 Years |
Tinkamos studijoms lytys | All |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: - Children 10-60 kg - Elective adenotomy, tonsillectomy or combined adenotonsillectomy under general anesthesia. - Written and oral informed parental consent. Exclusion Criteria: - ASA III or higher. - Weight < 10 kg or weight > 60 kg. - Congenital malformations of the mouth or throat. |
Rezultatas
Pirminės rezultatų priemonės
1. Patient satisfaction: a) Pain (VAS, use of opioids), b) Nausea and vomiting (score) [24 hrs]
Antrinės rezultatų priemonės
1. Effectivity (judged by reduced time in surgery) [1 hrs]
2. Secure airway management measured by desaturations/Sp02<92% and/or use of suxamethonium and bronchiolytic drugs. [24 hrs]