Clinical trial NCT01749631: Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients
Official title: A Prospective, Open-label, Multicenter, Post Marketing, Observational Study to Investigate the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation; Difficult
Keywords: Patients suspected to have difficult intubation
Intratracheal intubation
Difficult to intubate
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 97
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitals with operation theaters

Brief summary: 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.

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 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

Primary outcomes:
measure: Percentage of Participants With Successful Intubation (Clinical Success)
timeFrame: Start of intubation to completion of intubation (up to 15 minutes)
Secondary outcomes:
measure: Mean Duration of Induction (in Seconds)
timeFrame: From start of induction up to 15 minutes
measure: Percentage of Participants With Mallampati Score III and IV
timeFrame: Screening
measure: Mean Duration of Intubation Procedure (in Minutes)
timeFrame: Start of intubation to completion of intubation (up to 15 minutes)
measure: Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure
timeFrame: Start of intubation to completion of intubation (up to 15 minutes)
measure: Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane
timeFrame: From start of induction to completion of intubation (up to 30 minutes)
measure: Mean Number of Intubation Attempts
timeFrame: Start of intubation to completion of intubation (up to 15 minutes)
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Egypt
name: Amr Alaa
role: STUDY_DIRECTOR
References: