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IRCT2012072410385N1 IRCT 2013-02-04 Tehran University of Medical Sciences, Vice Chancellor for research Comparison of controlled and spontaneous respiration on postoperative nausea and vomiting and laryngospasm in children The comparison of the incidence of post operative nausea and vomiting and laryngospasm in controlled ventilation or spontaneous respiration in children underwent elective inguinal or femoral hernia surgery with general anesthesia 2010-03-21 anticipated 200 Complete https://irct.ir/trial/10892 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Elective inguinal or femoral hernia. Intervention 1: In spontaneous respiration group, after primary monitoring with ECG, SpO2 and NIBP and after induction of anesthesia with intra-venous fentanyl 1microg/Kg (Rotex Medica Manufactory), thiopentone 4mg/Kg (Rotex Medica Manufactory) and after increasing the dose of inhalation halothane (from 1 to 4%) (Nicholas Piramal India Manufactory) and when the optimal depth of anesthesia will be established, the patients will be intubated with an uncuffed tracheal tube, and the patients will be allowed to breath spontaneously. The anesthetic gas (Halothane 2% in equal dose of O2 and N2O) will be delivered to patients by a mapelson system. Neostigmine-atropine (Rasht Pharmaceutical Manufactory) will not be injected in patients in spontaneous respiration group at the end of surgery. The patients will be extubated in a light plan of anesthesia (movement of head and hands). Intervention 2: In control ventilation group, after primary monitoring with ECG, SpO2 and NIBP and after induction of anesthesia with intra-venous fentanyl 1microg/Kg (Rotex Medica Manufactory), thiopentone 4mg/Kg (Rotex Medica Manufactory), intra-venous atracurium(0.6 mg/kg) (Abooreyhan Manufactory) will be injected as muscle relaxant before intubation. After intubation with an uncuffed tracheal tube, the anesthetic gas (Halothane 2% in equal dose of O2 and N2O) will be delivered to patients by a circle system of anesthetic machine. The tidal volume will be set as 8-10 ml/kg and respiratory rate between 14-16 rate/minute. At the end of surgery, the muscle relaxant will be antagonized with neostigmine 50 microgram per kilogram-atropine 25 microgram per kilogram (Rasht Pharmaceutical Manufactory) in control ventilation group. The patients will be extubated in a light plan of anesthesia (movement of head and hands).
public Shahriari Ali
Roozbeh Hospital, South Kargar Street
Tehran Iran (Islamic Republic of) +98 21 5560 9951 Ashahriari@tums.ac.ir ;alibenmahdi@yahoo.com Tehran University of Medical Sciences, scientific Shahriari Ali
Roozbeh Hospital. South Kargar Street.
Tehran Iran (Islamic Republic of) +98 21 5560 9951 Ashahriari@tums.ac.ir ;alibenmahdi@yahoo.com Tehran University of Medical Sciences, Iran (Islamic Republic of) Inclusion criteria: children admitted for elective inguinal or femoral hernia surgery. Exclusion criteria: History of asthma; Fever; Morbid obesity; Cardiac disease; Metabolic disease ; Renal disease; Electrolyte imbalance; SpO2 under %85 2 years 7 years Both K40.2, K40 Bilateral inguinal hernia, without obstruction or gangrene, Unilateral or unspecified inguinal hernia, without obstruction or gangrene, Bilateral femoral hernia, without obstruction or gangrene, Unilateral or unspecified femoral hernia, without obstructio Treatment - Other Treatment - Other In spontaneous respiration group, after primary monitoring with ECG, SpO2 and NIBP and after induction of anesthesia with intra-venous fentanyl 1microg/Kg (Rotex Medica Manufactory), thiopentone 4mg/Kg (Rotex Medica Manufactory) and after increasing the dose of inhalation halothane (from 1 to 4%) (Nicholas Piramal India Manufactory) and when the optimal depth of anesthesia will be established, the patients will be intubated with an uncuffed tracheal tube, and the patients will be allowed to breath spontaneously. The anesthetic gas (Halothane 2% in equal dose of O2 and N2O) will be delivered to patients by a mapelson system. Neostigmine-atropine (Rasht Pharmaceutical Manufactory) will not be injected in patients in spontaneous respiration group at the end of surgery. The patients will be extubated in a light plan of anesthesia (movement of head and hands). In control ventilation group, after primary monitoring with ECG, SpO2 and NIBP and after induction of anesthesia with intra-venous fentanyl 1microg/Kg (Rotex Medica Manufactory), thiopentone 4mg/Kg (Rotex Medica Manufactory), intra-venous atracurium(0.6 mg/kg) (Abooreyhan Manufactory) will be injected as muscle relaxant before intubation. After intubation with an uncuffed tracheal tube, the anesthetic gas (Halothane 2% in equal dose of O2 and N2O) will be delivered to patients by a circle system of anesthetic machine. The tidal volume will be set as 8-10 ml/kg and respiratory rate between 14-16 rate/minute. At the end of surgery, the muscle relaxant will be antagonized with neostigmine 50 microgram per kilogram-atropine 25 microgram per kilogram (Rasht Pharmaceutical Manufactory) in control ventilation group. The patients will be extubated in a light plan of anesthesia (movement of head and hands). Nausea. Timepoint: Every 15 minutes to 6 hours after the end of the intervention. Method of measurement: Questionnaire. Vomiting. Timepoint: Every 15 minutes to 6 hours after the end of the intervention. Method of measurement: Questionnaire. Laryngospasm. Timepoint: Every minute to 30 minutes after the end of intervention. Method of measurement: Pulse oxymetry device. Tehran University of Medical Sciences, Vice Chancellor for research Approved 2012-12-30 Ethics committee of Tehran University Of Medical Sciences Qods St, Keshavarz Blvd Tehran Iran (Islamic Republic of) Approved 2009-01-29 Ethics committee of Shahid Beheshti University Of Medical Sciences Yemen St. Shahid Chamran Highway. Tehran Iran (Islamic Republic of)