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Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01749631
First received: December 12, 2012
Last updated: February 2, 2016
Last verified: February 2016
  Purpose
The purpose of this study was to record the effectiveness of sevoflurane for intubation in Egyptian, non-obstetric, difficult to intubate (DTI) patients undergoing surgery in regards to the rate of intubation success.

Condition
Intubation; Difficult

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Prospective, Open-label, Multicenter, Post Marketing, Observational Study to Investigate the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of Participants With Successful Intubation (Clinical Success) [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ] [ Designated as safety issue: No ]
    Participants were considered to have a successful intubation if intubation was achieved in less than 4 separate intubation attempts according to the guidelines of the American Society of Anesthesiologists (ASA). The number of intubation attempts was a maximum of 3 attempts, after which the intubation was considered a failure.


Secondary Outcome Measures:
  • Mean Duration of Induction (in Seconds) [ Time Frame: From start of induction up to 15 minutes ] [ Designated as safety issue: No ]
    The mean duration of induction (in seconds) was defined as the time required to reach a Ramsay Sedation Score (RSS) of 5 from start of induction. The RSS levels are defined as 1 = anxious, agitated or restless; 2 = calm, co-operative and communicative; 3 = response is quick to a voice command; 4 = response is slow to a voice command; 5 = slow or sluggish response; and 6 = no response at all.

  • Percentage of Participants With Mallampati Score III and IV [ Time Frame: Screening ] [ Designated as safety issue: No ]
    Mallampati classification correlates tongue size to pharyngeal size. The test is performed with the patient in the sitting position, head in a neutral position, the mouth wide open and the tongue protruding to its maximum, without phonation. Classification is assigned according to the extent the base of tongue is able to mask the visibility of pharyngeal structures: Class I = visualization of the soft palate, fauces; uvula, anterior and the posterior pillars; Class II = visualization of the soft palate, fauces and uvula; Class III = visualization of soft palate and base of uvula; and Class IV: only hard palate is visible, soft palate is not visible at all. A high score (Class III or IV) is associated with more difficult intubation.

  • Mean Duration of Intubation Procedure (in Minutes) [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ] [ Designated as safety issue: No ]
    The mean duration of intubation procedure (in minutes) was defined as the time from intubation start to the completion of the intubation process (from tube introduction to partial pressure of end-tidal carbon dioxide [PETCO2]).

  • Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ] [ Designated as safety issue: Yes ]
    The percentage of participants who experienced complications resulting from the intubation procedure including, but not limited to, bleeding, salivating, and lung aspiration.

  • Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane [ Time Frame: From start of induction to completion of intubation (up to 30 minutes) ] [ Designated as safety issue: Yes ]
    The percentage of participants who experienced difficulties related to the use of sevoflurane including, but not limited to, vocal cords adduction, coughing, movements, and apnea episodes.

  • Mean Number of Intubation Attempts [ Time Frame: Start of intubation to completion of intubation (up to 15 minutes) ] [ Designated as safety issue: No ]

Enrollment: 97
Study Start Date: December 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Difficult to Intubate (DTI) Participants
Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.

Detailed Description:
This is a prospective, open-label, multicenter, post marketing, observational study to investigate the effectiveness of sevoflurane anaesthesia in difficult to intubate (DTI; Mallampati Score III or IV) Egyptian patients who had been prescribed sevoflurane for anaesthesia by their treating physician.
  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitals with operation theaters
Criteria

Inclusion Criteria:

1. Male or non-pregnant female over 18 years who are undergoing surgery and using sevoflurane as the anesthetic agent and with Mallampati score III or IV

2. Patients with at least one of the below criteria:

  1. Anatomic

    • micrognathia - small mandible
    • macroglossia - large tongue
    • short or fixed neck
    • anterior vocal cords
  2. Trauma - neck or face
  3. Burns - airway edema
  4. Infections - edema

    • Retropharyngeal abscess
    • Submandibular abscess
    • epiglottitis
    • laryngotracheobronchitis (croup)
  5. Neoplasms; e.g., laryngeal tumors
  6. Rheumatoid arthritis - temporomandibular joint (TMJ) immobility
  7. Diabetes mellitus
  8. Waxy skin - palm test
  9. Decreased functional residual capacity (FRC) - rapid desaturation (due to displaced diaphragm, increased closing capacity and small airway closure, increased oxygen consumption)
  10. airway closure in supine position
  11. Morbid obesity (body mass index [BMI] >35)
  12. Airway edema
  13. Laryngospasm
  14. Edentulous patients - indent cheeks.

3. Patients willing to sign informed consent

Exclusion Criteria:

  1. Patients with present use of opioids and/or narcotic dependent.
  2. Patients with known sensitivity to sevoflurane or to other halogenated agents.
  3. Patients with known or suspected genetic susceptibility to malignant hyperthermia.
  4. Alcohol addictive patients.
  5. Patients with Renal insufficiency (baseline serum creatinine greater than 1.5 mg/dL)
  6. Patient is a pregnant or breastfeeding female
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749631

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Amr Alaa AbbVie Egypt
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01749631     History of Changes
Other Study ID Numbers: P13-805 
Study First Received: December 12, 2012
Results First Received: February 2, 2016
Last Updated: February 2, 2016
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by AbbVie:
Patients suspected to have difficult intubation
Intratracheal intubation
Difficult to intubate

Additional relevant MeSH terms:
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016