I-gel vs LMA Supreme in Laparoscopic Gynecological Surgery
Kata kunci
Abstrak
Deskripsi
Prospective, randomized and double-blind study, aged from 18 to 65 years undergoing elective laparoscopic gynecological surgery.
The patients are randomly assigned to 2 groups:
- Group 1: i-gel
- Group 2: LMA- Supreme
Procedure:
The investigation protocol contains the following sections:
1. Induction of anaesthesia. For preoperative sedation 0.02 mg/kg midazolam IV will be administered. 2 minutes of 0.2 µ/kg/min remifentanil and 6 mg kg st-1 propofol infusion, IV 1-2 mg kg-1 propofol . No muscle relaxant will be used for insertion of the airway device.
2. Bispectral index values will be held between 40-60.Bispectral index values will be within this interval by increasing or decreasing propofol infusion by 1 mg/kg after additional bolus dose of propofol (1 mg/kg).
3. Insertion of the airway device. The size of the airway device used is based on the manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once inserted, the cuff is be inflated with a manometer up to 60 cm H20 Data recorded: size of airway device, time an number of attempts.
4. Anesthesia maintenance will be ensured by 50% O2/air with 0.1-0.4 µ kg/min-1 remifentanil and 50-150 µ kg/ min-1 (4-10 mg/kg/hr) propofol IV infusion
5. Functionality of the gastric drainage channel of the airway device: passage of a 14 G size tube.
6. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 2 minutes after airway device insertion (T1), 10 minutes after insufflation (T2), before desufflation (T3), before removal of airway device (T4). The maximum pressure allowed is 40 cm H2O.
7. Ventilatory mechanics and parameters and hemodynamic parameters are measured at baseline, and at T1, T2, T3 and T4.
8. Perioperative complications: Cough, vomiting, laryngeal spasm, laryngeal Stridor, airway intervention requirements, hypoxia (SpO2 < 92%)
9. Removal of the airway device: Presence of blood - 3 level grading (1:no blood; 2: trace amounts of blood; 3: clear amounts of blood). Complications: sore throat ( VAS:10-point scale), dysphonia (yes/no), dysphagia (yes/no).
tanggal
| Terakhir Diverifikasi: | 01/31/2017 |
| Pertama Dikirim: | 09/21/2016 |
| Perkiraan Pendaftaran Telah Dikirim: | 10/02/2016 |
| Pertama Diposting: | 10/03/2016 |
| Pembaruan Terakhir Dikirim: | 02/07/2017 |
| Pembaruan Terakhir Diposting: | 02/08/2017 |
| Tanggal Mulai Studi Sebenarnya: | 10/31/2015 |
| Perkiraan Tanggal Penyelesaian Utama: | 01/31/2017 |
| Perkiraan Tanggal Penyelesaian Studi: | 02/28/2017 |
Kondisi atau penyakit
Intervensi / pengobatan
Device: Laryngeal mask Supreme
Device: i-gel
Tahap
Kelompok Lengan
| Lengan | Intervensi / pengobatan |
|---|---|
| Active Comparator: Laryngeal mask Supreme Insertion of the "Laryngeal mask Supreme" and evaluation of its clinical performance | Device: Laryngeal mask Supreme Evaluation of clinical performance in terms of Insertion, ventilation and complications |
| Experimental: i-gel Insertion of the "i-gel" and evaluation of its clinical performance | Device: i-gel Evaluation of clinical performance in terms of Insertion,ventilation and complications |
Kriteria kelayakan
| Usia yang Layak untuk Belajar | 18 Years Untuk 18 Years |
| Jenis Kelamin yang Layak untuk Belajar | Female |
| Menerima Relawan Sehat | Iya |
| Kriteria | Inclusion Criteria: 1. American Society of Anesthesiologists classification group I-II 2. between 18-65 years 3. undergoing elective laparoscopic gynecological surgery Exclusion Criteria: 1. Those with any neck or upper respiratory tract pathology 2. Those at risk of gastric content regurgitation/aspiration (previous upper Gastrointestinal system surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcers, full stomach, pregnancy) 3. Those with low pulmonary compliance or high airway resistance (chronic pulmonary diseases) 4. Obese patients (BMI >35) 5. Those with throat pain, dysphagia and dysphonia 6. Those with possible or previous difficult airway 7. Those with operations planned for longer than 4 hours 8. Conversion to laparatomy 9. Neuromuscular blocking agent used |
Hasil
Ukuran Hasil Utama
1. Change in Airway seal pressure values [At baseline and at 15, 30 and 60 minutes]
Ukuran Hasil Sekunder
1. visual quality [during pneumoperitoneum]
2. Gastric tube insertion [following airway device insertion up to 5 minutes]
3. Postoperative pharyngolaryngeal morbidity [postoperative 1th hour and 24th hour]
4. Sufficiency of pneumoperitoneum [baseline]
5. Change in Mean airway pressure values [At baseline and at 15, 30 and 60 minutes]
