Endotracheal Intubation With Sevoflurane in Surgical Pediatric Patients

NCT ID: NCT02429323

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-11-30

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

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.

Conditions

Anesthesia; Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

sevoflurane concentration 8%

sevoflurane concentration 8% from the start

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

use of 8% sevoflurane in compared to incremental dose increased each few breaths from 1% to 8%

incremental sevoflurane (1-8%)

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

Group Type: ACTIVE_COMPARATOR

Sevoflurane

Intervention Type: DRUG

use of 8% sevoflurane in compared to incremental dose increased each few breaths from 1% to 8%

Interventions

Sevoflurane

use of 8% sevoflurane in compared to incremental dose increased each few breaths from 1% to 8%

Intervention Type: DRUG

Other Intervention Names

sevorane abbott

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sulaimani

OTHER

Sponsor Role: lead

Responsible Party

Amir M. Boujan

Senior Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir M. Boujan, board

Role: STUDY_DIRECTOR

School of Medicine

References

James Duke, Pediatric Anesthesia, Anesthesia Secrets, Philadelphia 2011, Fourth Edition, Chapter 57, Page 396.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 10712710 (View on PubMed)

Other Identifiers

8

Identifier Type: -

Identifier Source: org_study_id