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

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03522402
Collaborator
(none)
38
1
2
10
3.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Other
Official Title:
Effect of Head Position on Minimum Alveolar Concentration of Endotracheal Intubation(MACEI)of Sevoflurane in Children With Obstructive Airway
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Oct 31, 2018

Arms and Interventions

Arm Intervention/Treatment
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
  • Outcome Measures

    Primary Outcome Measures

    1. minimum alveolar anesthetic concentration of endotracheal intubation [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.

    Secondary Outcome Measures

    1. intubation score [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.

    2. blood pressure include systolic and diastolic in mmHg [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.

    3. heart rate in bpm [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.

    4. bispectral index(BIS), number from 100 (awake) to 40-60(anesthetic status) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai9 Hospital Shanghai Shanghai China

    Sponsors and Collaborators

    • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    Investigators

    • Study Chair: Li Jing Jie, M.D., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Jingjie Li, PI, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    ClinicalTrials.gov Identifier:
    NCT03522402
    Other Study ID Numbers:
    • 2018-15-T15
    First Posted:
    May 11, 2018
    Last Update Posted:
    May 11, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jingjie Li, PI, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 11, 2018