NCT02429323

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

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

June 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

April 18, 2015

Last Update Submit

April 28, 2015

Conditions

Anesthesia; Reaction

Keywords

inductionpediatricssevofluraneintubation time

Outcome Measures

Primary Outcomes (1)

  • induction to intubation time in seconds

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

    during the surgery

Study Arms (2)

sevoflurane concentration 8%

ACTIVE COMPARATOR

sevoflurane concentration 8% from the start

Drug: Sevoflurane

incremental sevoflurane (1-8%)

ACTIVE COMPARATOR

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

Drug: Sevoflurane

Interventions

SevofluraneDRUG

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

Also known as: sevorane abbott
incremental sevoflurane (1-8%)sevoflurane concentration 8%

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 2-7 years old American society of anesthesiologists physical status class 1 and 2 scheduled for elective adenotonsillectomy operations

You may not qualify if:

  • Children with extreme weight, suspicion of difficult airway, moved during laryngoscopy, or more than one trial of laryngoscopy needed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

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

    BACKGROUND

  • Johr M. Anaesthesia for tonsillectomy. Curr Opin Anaesthesiol. 2006 Jun;19(3):260-1. doi: 10.1097/01.aco.0000192789.78139.54. No abstract available.

    PMID: 16735808BACKGROUND

  • Chawathe M, Zatman T, Hall JE, Gildersleve C, Jones RM, Wilkes AR, Aguilera IM, Armstrong TS. Sevoflurane (12% and 8%) inhalational induction in children. Paediatr Anaesth. 2005 Jun;15(6):470-5. doi: 10.1111/j.1460-9592.2005.01478.x.

    PMID: 15910347BACKGROUND

  • Inomata S, Yamashita S, Toyooka H, Yaguchi Y, Taguchi M, Sato S. Anaesthetic induction time for tracheal intubation using sevoflurane or halothane in children. Anaesthesia. 1998 May;53(5):440-5. doi: 10.1046/j.1365-2044.1998.00338.x.

    PMID: 9659016BACKGROUND

  • Politis GD, Tobin JR, Morell RC, James RL, Cantwell MF. Tracheal intubation of healthy pediatric patients without muscle relaxant: a survey of technique utilization and perceptions of safety. Anesth Analg. 1999 Apr;88(4):737-41. doi: 10.1097/00000539-199904000-00009.

    PMID: 10195514BACKGROUND

  • Redhu S, Jalwal GK, Saxena M, Shrivastava OP. A Comparative Study of Induction, Maintenance and Recovery Characteristics of Sevoflurane and Halothane Anaesthesia in Pediatric Patients (6 months to 6 years). J Anaesthesiol Clin Pharmacol. 2010 Oct;26(4):484-7.

    PMID: 21547175BACKGROUND

  • Blair JM, Hill DA, Bali IM, Fee JP. Tracheal intubating conditions after induction with sevoflurane 8% in children. A comparison with two intravenous techniques. Anaesthesia. 2000 Aug;55(8):774-8. doi: 10.1046/j.1365-2044.2000.01470.x.

    PMID: 10947692BACKGROUND

  • Fenlon S, Pearce A. Sevoflurane induction and difficult airway management. Anaesthesia. 1997 Mar;52(3):285-6. No abstract available.

    PMID: 9124682BACKGROUND

  • Epstein RH, Stein AL, Marr AT, Lessin JB. High concentration versus incremental induction of anesthesia with sevoflurane in children: a comparison of induction times, vital signs, and complications. J Clin Anesth. 1998 Feb;10(1):41-5. doi: 10.1016/s0952-8180(97)00218-3.

    PMID: 9526937BACKGROUND

  • Baum VC, Yemen TA, Baum LD. Immediate 8% sevoflurane induction in children: a comparison with incremental sevoflurane and incremental halothane. Anesth Analg. 1997 Aug;85(2):313-6. doi: 10.1097/00000539-199708000-00013.

    PMID: 9249106BACKGROUND

  • Dubois MC, Piat V, Constant I, Lamblin O, Murat I. Comparison of three techniques for induction of anaesthesia with sevoflurane in children. Paediatr Anaesth. 1999;9(1):19-23.

    PMID: 10712710BACKGROUND

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Amir M. Boujan, board

    School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Anesthesiologist

Study Record Dates

First Submitted

April 18, 2015

First Posted

April 29, 2015

Study Start

June 1, 2011

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

April 29, 2015

Record last verified: 2015-04