Endotracheal Intubation With Sevoflurane in Surgical Pediatric Patients

April 28, 2015 updated by: Amir M. Boujan, University of Sulaimani

Endotracheal Intubation With Sevoflurane in Surgical Pediatric Patients: Incremental Versus High Concentration Inhalation Induction

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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

7 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction to intubation time in seconds
Time Frame: during the surgery
effect of high concentration of sevoflurane on shortening the induction to intubation time
during the surgery

Collaborators and Investigators

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

Sponsor

University of Sulaimani

Investigators

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

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

June 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

April 18, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2015

Last Update Submitted That Met QC Criteria

April 28, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8

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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