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

AbbVie

Status: Completed

Conditions: Intubation; Difficult

Study type: Observational

Funder types: Industry

Identifiers

NCT01749631

P13-805

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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:

3. Anatomic

   • micrognathia - small mandible
   • macroglossia - large tongue
   • short or fixed neck
   • anterior vocal cords

4. Trauma - neck or face

5. Burns - airway edema

6. Infections - edema

   • Retropharyngeal abscess
   • Submandibular abscess
   • epiglottitis
   • laryngotracheobronchitis (croup)

7. Neoplasms; e.g., laryngeal tumors

8. Rheumatoid arthritis - temporomandibular joint (TMJ) immobility

9. Diabetes mellitus

10. Waxy skin - palm test

11. Decreased functional residual capacity (FRC) - rapid desaturation (due to displaced diaphragm, increased closing capacity and small airway closure, increased oxygen consumption)

12. airway closure in supine position

13. Morbid obesity (body mass index [BMI] >35)

14. Airway edema

15. Laryngospasm

16. Edentulous patients - indent cheeks.

17. 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

Trial design

97 participants in 1 patient group

Difficult to Intubate (DTI) Participants

Description:

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.