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

NCT03522402 | Unknown DMC

• 1 other identifier: 2018-15-T15
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Sevoflurane; Endotracheal Intubation

Keywords

head position; obstructive airway; minimum alveolar concentration(MACendotracheal intubation); sevoflurane concentration

Outcome Measures

Primary Outcomes (1)

• minimum alveolar anesthetic concentration of endotracheal intubation

  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 Outcomes (4)

• intubation score

  The intubation score is obtained when tracheal intubation was inserted immediately.

• blood pressure include systolic and diastolic in mmHg

  Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.

• heart rate in bpm

  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)

  Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.

Study Arms (2)

30 degree rotated lateral position

EXPERIMENTAL

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

neutral position

ACTIVE COMPARATOR

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

Interventions

Sevoflurane DRUG

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%.

Also known as: 30 degree rotated lateral position and neutral position

30 degree rotated lateral position; neutral position

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Shanghai9 Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (7)

• Tanaka S, Tsuchida H, Nakabayashi K, Seki S, Namiki A. The effects of sevoflurane, isoflurane, halothane, and enflurane on hemodynamic responses during an inhaled induction of anesthesia via a mask in humans. Anesth Analg. 1996 Apr;82(4):821-6. doi: 10.1097/00000539-199604000-00025.

  PMID: 8615504 BACKGROUND

• 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.

  PMID: 1994760 BACKGROUND

• 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.

  PMID: 14564561 BACKGROUND

• 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.

  PMID: 10910489 BACKGROUND

• 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.

  PMID: 2894106 BACKGROUND

• 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.

  PMID: 22017661 BACKGROUND

• 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.

  PMID: 9135350 BACKGROUND

Related Links

• The effects of premedication on inhaled induction of anesthesia with sevoflurane.

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Li Jing Jie, M.D.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2018
• Study Completion: October 31, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

CN (1)