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

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ClinicalTrials.gov Identifier: NCT03522402
Recruitment Status : Unknown
Verified May 2018 by Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Recruitment status was:  Enrolling by invitation
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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
Sevoflurane Endotracheal Intubation Drug: Sevoflurane Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 1, 2018
Actual Primary Completion Date : January 1, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

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 Name: 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 Name: 30 degree rotated lateral position and neutral position




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522402


Locations
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China, Shanghai
Shanghai9 Hospital
Shanghai, Shanghai, China
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Investigators
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Study Chair: Li Jing Jie, M.D. Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Additional Information:
Publications:
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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    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
head position
obstructive airway
minimum alveolar concentration(MACendotracheal intubation)
sevoflurane concentration
Additional relevant MeSH terms:
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Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs