NCT01958138

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

June 19, 2012

Last Update Submit

February 11, 2021

Conditions

Complication of Anesthesia

Keywords

Laryngeal Mask AirwayPropofolIsofluranePediatric patientsEmergence

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

propofol with Isoflurane

EXPERIMENTAL

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)

alone isoflurane

ACTIVE COMPARATOR

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)

Interventions

comparison of group-I (low dose propofol with isoflurane)DRUG

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

Also known as: group-II (alone isoflurane MAC 1.2%)
alone isofluranepropofol with Isoflurane

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Operating room at Aga Khan University Hospital

Karachi, Sindh, 3500, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 8767151BACKGROUND

  • 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.

    PMID: 6349667BACKGROUND

  • 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.

    PMID: 9512850BACKGROUND

  • 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.

    PMID: 9051538BACKGROUND

  • 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.

    PMID: 9534633BACKGROUND

  • 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.

    PMID: 11704447BACKGROUND

  • 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.

    PMID: 10234495BACKGROUND

  • 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.

    PMID: 8679367BACKGROUND

  • 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.

    PMID: 12358660BACKGROUND

MeSH Terms

Interventions

PropofolIsoflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthers

Study Officials

  • dileep kumar, FCPS

    Aga Khan University Hospital Karachi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 19, 2012

First Posted

October 9, 2013

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

November 1, 2013

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)