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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intubation; Difficult

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No