Isoflurane Versus Propofol for Removal of LMA in Children

February 11, 2021 updated by: Dileep Kumar, Aga Khan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • 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;

  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:

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 3500
        • Operating room at Aga Khan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: 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 Names:
  • group-II (alone isoflurane MAC 1.2%)
ACTIVE_COMPARATOR: alone isoflurane
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)
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 Names:
  • group-II (alone isoflurane MAC 1.2%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergence airway complications
Time Frame: 15 minutes of continuous monitoring and time frame was started from the LMA removal
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
Time Frame: 15 minutes of continuous monitoring and time frame was started from the LMA removal
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
Time Frame: 0-45 minutes of continuous monitoring and time frame was started from the PACU admission to discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: dileep kumar, FCPS, Aga Khan University Hospital Karachi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2012

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

October 8, 2013

First Posted (ESTIMATE)

October 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1995-Ane-ERC-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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