Isoflurane Versus Propofol for Removal of LMA in Children
NCT ID: NCT01958138
Last Updated: 2021-02-15
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2012-04-30
2013-11-30
Brief Summary
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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.
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Detailed Description
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* 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;
1. Emergence time ( patient awakening time),
2. Duration of recovery room stay (Post anesthesia care unit),
3. 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,
4. 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:
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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propofol with Isoflurane
Propofol with Isoflurane, Group-I is the intervention arm with combination of two drugs such as low dose propofol and Isoflurane MAC awake.
comparison of group-I (low dose propofol with isoflurane)
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
alone isoflurane
The group-II is the control arm of study by using the only Isoflurane 1.2 MAC
comparison of group-I (low dose propofol with isoflurane)
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
Interventions
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comparison of group-I (low dose propofol with isoflurane)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* mallampatis class I \& II.
* Age from 2 years to 10 years.
* Elective surgical patients for below umbilical general surgical procedures.
Exclusion Criteria
* 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
2 Years
10 Years
ALL
Yes
Sponsors
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Aga Khan University
OTHER
Responsible Party
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Dileep Kumar
Assistant Professor
Principal Investigators
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dileep kumar, FCPS
Role: PRINCIPAL_INVESTIGATOR
Aga Khan University Hospital Karachi
Locations
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Operating room at Aga Khan University Hospital
Karachi, Sindh, Pakistan
Countries
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References
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Frediani M, Blanchini G, Capanna M, Casini L, Costa M, Uggeri S, Meini M, Pacini P. [The laryngeal mask in pediatric anesthesia]. Minerva Anestesiol. 1996 Mar;62(3):65-71. Italian.
Brain AI. The laryngeal mask--a new concept in airway management. Br J Anaesth. 1983 Aug;55(8):801-5. doi: 10.1093/bja/55.8.801.
Samarkandi AH. Awake removal of the laryngeal mask airway is safe in paediatric patients. Can J Anaesth. 1998 Feb;45(2):150-2. doi: 10.1007/BF03013254.
Splinter WM, Reid CW. Removal of the laryngeal mask airway in children: deep anesthesia versus awake. J Clin Anesth. 1997 Feb;9(1):4-7. doi: 10.1016/S0952-8180(96)00217-6.
Nunez J, Hughes J, Wareham K, Asai T. Timing of removal of the laryngeal mask airway. Anaesthesia. 1998 Feb;53(2):126-30. doi: 10.1046/j.1365-2044.1998.00298.x.
Pappas AL, Sukhani R, Lurie J, Pawlowski J, Sawicki K, Corsino A. Severity of airway hyperreactivity associated with laryngeal mask airway removal: correlation with volatile anesthetic choice and depth of anesthesia. J Clin Anesth. 2001 Nov;13(7):498-503. doi: 10.1016/s0952-8180(01)00318-x.
Baird MB, Mayor AH, Goodwin AP. Removal of the laryngeal mask airway: factors affecting the incidence of post-operative adverse respiratory events in 300 patients. Eur J Anaesthesiol. 1999 Apr;16(4):251-6. doi: 10.1046/j.1365-2346.1999.00476.x.
Kitching AJ, Walpole AR, Blogg CE. Removal of the laryngeal mask airway in children: anaesthetized compared with awake. Br J Anaesth. 1996 Jun;76(6):874-6. doi: 10.1093/bja/76.6.874.
Afshan G, Chohan U, Qamar-Ul-Hoda M, Kamal RS. Is there a role of a small dose of propofol in the treatment of laryngeal spasm? Paediatr Anaesth. 2002 Sep;12(7):625-8. doi: 10.1046/j.1460-9592.2002.00937.x.
Other Identifiers
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1995-Ane-ERC-11
Identifier Type: -
Identifier Source: org_study_id
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