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IRCT20170314033069N6 IRCT 2023-08-07 Rasht University of Medical Sciences Comparison of tracheal intubation and I-GEL in gynecology laparoscopic surgery under general anesthesia A comparative study between endotracheal tube and I-GEL in gynecological laparoscopic surgeries under general anesthesia; A double blind clinical trial study 2023-08-23 anticipated 92 Complete https://irct.ir/trial/71808 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be assigned to two groups A, intubation with tracheal tube and B: I-gel by a random sequence created in blocks of four by WinPepi software, which was created by a statistical consultant and will be performed by a technician who is not aware of the goals of the study, Blinding description: This study will be double-blinded. Before entering the surgeon to the operating room, induction of anesthesia and establishment of the airway will be done by the anesthesiologist, and anesthesia curtains will be placed. Then, during the procedure, a trained medical student will collect information. In this way, the patient, the evaluator (medical student), and the surgeon who reports satisfaction are unaware of the groups. 3 Comparison of two methods of tracheal intubation and I-GEL in gynecology laparoscopic surgery under general anesthesia. Intervention 1: Intervention group 1: In the endotracheal tube group, after the laryngoscopy of the patient by the anesthesiologist, the patient will be intubated with an appropriate size 7 or 7.5 tracheal tube depending on the patient's condition. If it was not possible to pass the tracheal tube through the vocal cords for the first time, laryngoscopy will be performed again. If the patient cannot be intubated (in two attempts), he will be excluded from the study. Intervention 2: Intervention group 2: In the I-gel group, first the right size of I-gel will be selected for the patient. The size of the I-gel is determined based on the patient's weight. Accordingly, for patients weighing 30-50 kilograms Number 3, for 50-90 kilograms Number 4, and for those above 90 kilograms Number 5 will be suitable. After choosing the right size for the patient, the I-gel will be moistened with crystalloid and then the placement of the I-gel will be done by the anesthesiologist. If adequate ventilation is not established after two attempts, the procedure will be considered a failure and the patient will be excluded from the study. No - There is not a plan to make this available Justification or reason for not sharing IPD is Not decided yet
public Dr Gelareh Biazar
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 gelarehbiazar1386@gmail.com Rasht University of Medical Sciences scientific Dr Gelareh Biazar
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 gelarehbiazar1386@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Elective laparoscopic surgeries Full fasting time of 8 hours No history of reflux American Society of Anesthesiologists (ASA) I,II Age range between 18-55 years The duration of the operation is less than two hours Body mass index (BMI) range between 25-35 kg.m2 18 years 55 years Female Having any pathological problems in the neck and upper airway Patients at high risk for aspiration (Hiatus hernia , gastroesophageal reflux) Failure to open the mouth more than 2.5 centimeter Emergency surgery Patients with non-observance of standard times for liquids and solids (2 hours before the operation of clear liquids, 6-7 hours of solid foods) Y70.1 Therapeutic (nonsurgical) and rehabilitative anesthesiology devices associated with adverse incidents Treatment - Devices Treatment - Devices Intervention group 1: In the endotracheal tube group, after the laryngoscopy of the patient by the anesthesiologist, the patient will be intubated with an appropriate size 7 or 7.5 tracheal tube depending on the patient's condition. If it was not possible to pass the tracheal tube through the vocal cords for the first time, laryngoscopy will be performed again. If the patient cannot be intubated (in two attempts), he will be excluded from the study. Intervention group 2: In the I-gel group, first the right size of I-gel will be selected for the patient. The size of the I-gel is determined based on the patient's weight. Accordingly, for patients weighing 30-50 kilograms Number 3, for 50-90 kilograms Number 4, and for those above 90 kilograms Number 5 will be suitable. After choosing the right size for the patient, the I-gel will be moistened with crystalloid and then the placement of the I-gel will be done by the anesthesiologist. If adequate ventilation is not established after two attempts, the procedure will be considered a failure and the patient will be excluded from the study. Difficulty of establishing the airway. Timepoint: 3 minutes after induction of anesthesia. Method of measurement: Number of attempts to establish the airway. Surgeon's satisfaction with the operation field in terms of gastric dilatation. Timepoint: After surgery. Method of measurement: Scoring from 0 (an empty stomach) to 10 (a fully distended stomach). Postoperative complications. Timepoint: After surgery. Method of measurement: Observation. Airway pressure. Timepoint: After establishing the airway. Method of measurement: Ventilator. Hemodynamic changes. Timepoint: Five stations (before pneumoperitoneum, 15 minutes after pneumoperitoneum, 30 minutes after pneumoperitoneum, immediately after gas release and 15 minutes after gas release). Method of measurement: Monitoring. Rasht University of Medical Sciences Approved 2023-07-26 Ethics committee of Guilan University of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht Rasht Guilan Iran (Islamic Republic of)