Effect of Head Position on MACEI of Sevoflurane in Children With Obstructive Airway (MACEI)

May 10, 2018 updated by: Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Effect of Head Position on Minimum Alveolar Concentration of Endotracheal Intubation（MACEI）of Sevoflurane in Children With Obstructive Airway

Children scheduled for tonsillectomy surgery were recruited into the study. General anesthesia was induced with 8% sevoflurane inhaled with 8 l.min-1 of oxygen via mask, followed by adjustment of inspired sevoflurane to the target concentration based on the result in previous patient at which laryngoscopy and tracheal intubation were attempted and maintained for 12 min. All responses to tracheal intubation were assessed. At the end of the procedure, sevoflurane was titrated to the target concentration, which was kept constant for 12 min before a standard stimulus was applied to determine whether the children was awake. The Dixon's 'up and down'method was used to determine progression of subsequent concentrations.The aim of this study was to determine whether the minimum alveolar concentration of endotracheal intubation（MACEI）of sevoflurane in children with obstructive airway are different from that observed in normal children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Detailed Description

38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position. All patients were preoxygenated using 100% oxygen with a normal tidal volumen for 3 min. The circuit was primed with sevoflurane 8% at a fresh gas flow of 8 Litre/min （L/min） for 1 min. Anaesthesia was induced with inhaled sevoflurane up to 5% in oxygen via facemask with fresh gas flow at 6 L/min.After loss of consciousness, the inspired concentration of sevoflurane was maintained 10-12min a predetermined end-tidal concentration. A single experienced anaesthetist in the use of endotracheal devices inserted the devices according to the manufacturer's recommendations. Neuromuscular blocking agents and other intravenous anesthetics were not given. One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement". Assesment was made for jaw relaxation and graded with intubation score. The sum of intubation scores >4 was defined as a failure of insertion. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%. If the endotracheal device insertion was successful, sevoflurane concentration for the next patient was decrease by 0.5%. If not, sevoflurane concentration was increased by the same amount for the next patient. For their comfort, patients experiencing movement received a 2 mg/kg bolus dose of propofol,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg.If the endotracheal device insertion was successful,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg was also administered.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai9 Hospital

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • class I or II
  • children aged 2-8 years
  • children with obstruction airway under general anesthesia undergoing tonsillectomy surgery
  • signed informed consent

Exclusion Criteria:

  • Patients with a history of adverse reactions to sevoflurane
  • Patients with a potentially difficult airway (Mallampati III or IV, a limited mouth opening and/or cervical spine disease)
  • Patients with reactive airway disease
  • Signs of upper respiratory infection
  • Violate experimental scheme
  • refused to participate

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 30 degree rotated lateral position
19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in 30 degree rotated lateral position. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
Drug: Sevoflurane
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
Other Names:
  • 30 degree rotated lateral position and neutral position
Active Comparator: neutral position
19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in the neutral position.The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
Drug: Sevoflurane
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
Other Names:
  • 30 degree rotated lateral position and neutral position

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
minimum alveolar anesthetic concentration of endotracheal intubation
Time Frame: The sevoflurane concentration is obtained when tracheal intubated immediately.
To compare the minimum alveolar anesthetic concentration of endotracheal intubation required for different head position in children with obstructive airway.
The sevoflurane concentration is obtained when tracheal intubated immediately.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
intubation score
Time Frame: The intubation score is obtained when tracheal intubation was inserted immediately.
One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement". Assesment was made for jaw relaxation and graded with intubation score. The sum of intubation scores >4 was defined as a failure of insertion.
The intubation score is obtained when tracheal intubation was inserted immediately.
blood pressure include systolic and diastolic in mmHg
Time Frame: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
To compare the evolution of blood pressure include systolic and diastolic during different head position group.
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
heart rate in bpm
Time Frame: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
To compare the evolution of heart rate during different head position group.
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
bispectral index（BIS）, number from 100 (awake) to 40-60(anesthetic status)
Time Frame: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
To compare the evolution of of bispectral index values during different head position group.
Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Li Jing Jie, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-15-T15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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