Endotracheal Intubation With Sevoflurane in Surgical Pediatric Patients

Sponsor
University of Sulaimani (Other)
Overall Status
Completed
CT.gov ID
NCT02429323
Collaborator
(none)
100
2
5

Study Details

Study Description

Brief Summary

Aim of the study is to compare the optimal time needed for successful tracheal intubation with immediate 8% sevoflurane and incremental sevoflurane induction in surgical pediatric patients undergoing adenotonsillectomy without using muscle relaxants or opioids

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Investigators studied 100 pediatric surgical patients admitted to Sulaimani Teaching Hospital in the Otorhinolaryngology, Head and Neck Surgical Department, from the first of June 2011 to the first of September 2011, Children aged 2-7 years,both genders, ASA physical statuses І and II (ASA I: a healthy normal patient, while ASA II: a patient with mild systemic disease with no functional limitations) were scheduled for elective adenotonsillectomy operations. They were randomly divided into two equal groups according to the induction method.

Group 1 (G1) using incremental induction with sevoflurane (1-8 %) in 100% O2, the vapor concentration is increased by 1% every few breaths.

Group 2 (G2) high concentration of sevoflurane (8%) in 100% O2 from the beginning of induction.

None of them is given premedication or any other adjunct drugs until successful intubation is done; ventilation was assisted and then controlled when possible. If upper airway obstruction occurred, an oropharyngeal airway was immediately inserted. Attempts were made to obtain venous access before laryngoscopy. All patients monitored with electrocardiography (ECG), noninvasive blood pressure monitoring (NIBP), pulse oximetry, and temperature measurements.

Children with extreme weight, suspicion of difficult airway, moved during laryngoscopy, or more than one trial of laryngoscopy needed were excluded from this study.

The endotracheal tube (ETT) size was selected by using the formula (age/4) + 4.5. Only a single laryngoscopy attempt was allowed. Small, brief movements of extremities occurring after (ETT) placement did not considered as exclusion criteria. Anesthesia was delivered by anesthetic machine (Datex Ohmeda), using an Ayer's T-piece with Jackson Ree's modification system, with a fresh gas flow of 6 L/min through a Sevoflurane vaporizer.

Patients were observed until eyelash reflex disappears, pupils centered and constricted. Jaw relaxation and movements were monitored. Ventilation was controlled till the time of laryngoscopy; the vocal cords were completely visible, orotracheal intubation done with Macintosh laryngoscope blade size 2 by the same anesthetist for all the patients. The time from induction until successful tracheal intubation is recorded.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Endotracheal Intubation With Sevoflurane in Surgical Pediatric Patients: Incremental Versus High Concentration Inhalation Induction
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: sevoflurane concentration 8%

sevoflurane concentration 8% from the start

Drug: Sevoflurane
use of 8% sevoflurane in compared to incremental dose increased each few breaths from 1% to 8%
Other Names:
  • sevorane abbott
  • Active Comparator: incremental sevoflurane (1-8%)

    incremental increase of the concentration each few breaths from 1% to 8%

    Drug: Sevoflurane
    use of 8% sevoflurane in compared to incremental dose increased each few breaths from 1% to 8%
    Other Names:
  • sevorane abbott
  • Outcome Measures

    Primary Outcome Measures

    1. induction to intubation time in seconds [during the surgery]

      effect of high concentration of sevoflurane on shortening the induction to intubation time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Children 2-7 years old American society of anesthesiologists physical status class 1 and 2 scheduled for elective adenotonsillectomy operations
    Exclusion Criteria:
    • Children with extreme weight, suspicion of difficult airway, moved during laryngoscopy, or more than one trial of laryngoscopy needed

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Sulaimani

    Investigators

    • Study Director: Amir M. Boujan, board, School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Amir M. Boujan, Senior Anesthesiologist, University of Sulaimani
    ClinicalTrials.gov Identifier:
    NCT02429323
    Other Study ID Numbers:
    • 8
    First Posted:
    Apr 29, 2015
    Last Update Posted:
    Apr 29, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Amir M. Boujan, Senior Anesthesiologist, University of Sulaimani
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 29, 2015