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

Overview

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.

Full Title of Study: “Effect of Head Position on Minimum Alveolar Concentration of Endotracheal Intubation(MACEI)of Sevoflurane in Children With Obstructive Airway”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: January 1, 2018

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.

Interventions

  • 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%.

Arms, Groups and Cohorts

  • 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%.
  • 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%.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Ninth People’s Hospital Affiliated to Shanghai Jiao Tong University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jingjie Li, PI – Shanghai Ninth People’s Hospital Affiliated to Shanghai Jiao Tong University
  • Overall Official(s)
    • Li Jing Jie, M.D., Study Chair, Shanghai Ninth People’s Hospital Affiliated to Shanghai Jiao Tong University

References

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Yasuda N, Lockhart SH, Eger EI 2nd, Weiskopf RB, Liu J, Laster M, Taheri S, Peterson NA. Comparison of kinetics of sevoflurane and isoflurane in humans. Anesth Analg. 1991 Mar;72(3):316-24. doi: 10.1213/00000539-199103000-00007.

Wajima Z, Inoue T, Yoshikawa T, Imanaga K, Ogawa R. Changes in hemodynamic variables and catecholamine levels after rapid increase in sevoflurane or isoflurane concentration with or without nitrous oxide under endotracheal intubation. J Anesth. 2000;14(4):175-9. doi: 10.1007/s005400070001.

Goff MJ, Arain SR, Ficke DJ, Uhrich TD, Ebert TJ. Absence of bronchodilation during desflurane anesthesia: a comparison to sevoflurane and thiopental. Anesthesiology. 2000 Aug;93(2):404-8. doi: 10.1097/00000542-200008000-00018.

Helbo-Hansen S, Ravlo O, Trap-Andersen S. The influence of alfentanil on the intubating conditions after priming with vecuronium. Acta Anaesthesiol Scand. 1988 Jan;32(1):41-4. doi: 10.1111/j.1399-6576.1988.tb02685.x.

Makkar JK, Ghai B, Bhardwaj N, Wig J. Minimum alveolar concentration of desflurane with fentanyl for laryngeal mask airway removal in anesthetized children. Paediatr Anaesth. 2012 Apr;22(4):335-40. doi: 10.1111/j.1460-9592.2011.03712.x. Epub 2011 Oct 21.

Thwaites A, Edmends S, Smith I. Inhalation induction with sevoflurane: a double-blind comparison with propofol. Br J Anaesth. 1997 Apr;78(4):356-61. doi: 10.1093/bja/78.4.356.

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