Isoflurane Versus Propofol for Removal of LMA in Children

Study Overview
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Brief Summary
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The study will be done in paediatric patients by comparing two different techniques of Laryngeal Mask Airway (LMA) removal under deep anesthetic plane. The both study techniques will be compared for safe LMA removal on the basis of adverse airway events and emergence time duration and recovery room stay timing.

Detailed Description
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Study will be start after confirming the approval of institutional ethical review committee and after fulfilling the study inclusion criteria. The detailed study protocol will be explain to the parent/guardian and written & informed consent will be taking on his/her will. Inclusion Criteria Age between 2 to 10 years, American Society of Anaesthesiologists (ASA) physical status I & II, Patient is not contraindicated to Laryngeal Mask Airway insertion, Elective below umbilical general surgical procedures patient is planned for general anesthesia with spontaneous breathing. Fifty patients will participate in both study groups. All patients will be premedicated with oral midazolam 0.3mg/kg, 45 to 60 minutes prior to induction. After arrival of patients in operating room, routine anesthesia monitoring will be applied and baseline blood pressure, heart rate, respiratory rate and oxygen saturation will be recorded. Patient will be induced with anesthetic induction inhalational agent (sleeping drug) sevoflurane 8% with oxygen by pediatric anesthesia circle system. The sevoflurane concentration will be adjusted to 3% to 4% once the adequate depth of anesthesia achieved, as evident by jaw relaxation and tolerance of an oral airway. The LMA will be placed after the insertion of intravenous line. The LMA size will be determined as per manufacturer's recommendation; which suggest 1.5 LMA size for 5-10 kg, size 2 for 10-20 kg and size 2.5 for 20-30 kg. The anesthesia will be maintained with isoflurane in 60% nitrous oxide and 40% oxygen. Patients will be ventilated by spontaneous mode by 'Mapleson F anesthesia circuit' and for above 25 Kg patient, the circle system will be used. Caudal analgesia was standardised in both study groups. Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I. The group-II LMA will removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen. In both groups; LMA will be removed with inflated cuff, throat was suctioned and patients were turned into lateral recovery position. Isoflurane and nitrous oxide were turned off and 100% oxygen supplemented till the patient had regained consciousness. All participants were transported to Post Anesthesia Care Unit (PACU) once ensured airway patency and peripheral oxygen saturation (Sp02) greater than 93% on room air. Children were allowed to wake up effortlessly in PACU at oxygen 5 litters/minutes via Hudson mask. - The following study variables will be recorded; Emergence time ( patient awakening time), Duration of recovery room stay (Post anesthesia care unit), Smooth Laryngeal Mask Airway removal will be assessed by Cough, Hypersalivation, 02 desaturation < 90%, Teeth clenching, Airway obstruction requiring jaw support, Laryngospasm, Bronchospasm, Retching, Vomiting, Confounding variables will be assessed like; Patients demographics, Duration of surgery, Duration of anesthesia, Type of surgery, Mode of analgesia Number of Laryngeal Mask Airway insertion attempts:

Official Title
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Isoflurane Versus Combination Of Propofol With Isoflurane For Removal Of Laryngeal Mask Airway In Children

Conditions
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Complication of Anesthesia

Intervention / Treatment
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* Drug: comparison of group-I (low dose propofol with isoflurane)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist class-I & II patients. mallampatis class I & II. Age from 2 years to 10 years. Elective surgical patients for below umbilical general surgical procedures. Exclusion Criteria: Congenital disorders Airway or facial abnormalities Reactive airway disease/asthma Anticipated difficult airway History of Upper respiratory tract infection in last 3 weeks History of gastroesophageal reflux disorders Known allergic to isoflurane and propofol

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol with Isoflurane<br>Propofol with Isoflurane, Group-I is the intervention arm with combination of two drugs such as low dose propofol and Isoflurane MAC awake. | Drug: comparison of group-I (low dose propofol with isoflurane)<br>* Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I. The group-II LMA will be removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen<br>* Other names: group-II (alone isoflurane MAC 1.2%);|
| Active Comparator: alone isoflurane<br>The group-II is the control arm of study by using the only Isoflurane 1.2 MAC | Drug: comparison of group-I (low dose propofol with isoflurane)<br>* Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I. The group-II LMA will be removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen<br>* Other names: group-II (alone isoflurane MAC 1.2%);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence airway complications | Smooth LMA removal will be assessed by adverse airway events like; coughing, bucking, hypersalivation, O2 desaturation (Sp02<90%), airway obstruction (noisy or stridor breathing) requiring jaw support, laryngospasm, bronchospasm, retching and vomiting, time duration from LMA removal up to 15 minutes. | 15 minutes of continuous monitoring and time frame was started from the LMA removal | 
| Emergence time duration | Impact on emergence time duration because of intervention such as delayed awakening or responding | 15 minutes of continuous monitoring and time frame was started from the LMA removal | 
| Post anaesthesia care unit stay time duration | Impact of intervention on post anaesthesia care unit admission to discharge time duration | 0-45 minutes of continuous monitoring and time frame was started from the PACU admission to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laryngeal Mask Airway, Propofol, Isoflurane, Pediatric patients, Emergence