N/A
Completed N=97
Investigation of the Effectiveness of Sevoflurane Anaesthesia in Difficult to Intubate Egyptian Patients
Intubation; Difficult
Source: ClinicalTrials.gov NCT01749631 ↗
Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants With Successful Intubation (Clinical Success) — 96.9; 3.1 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Successful Intubation (Clinical Success) |
96.9; 3.1 | — |
| SECONDARY Mean Duration of Induction (in Seconds) |
220.45 | — |
| SECONDARY Percentage of Participants With Mallampati Score III and IV |
93.8; 5.2 | — |
| SECONDARY Mean Duration of Intubation Procedure (in Minutes) |
1.77 | — |
| SECONDARY Percentage of Participants Who Experienced Complications Resulting From Intubation Procedure |
1.03; 1.03 | — |
| SECONDARY Percentage of Participants Who Experienced Difficulties Related to the Use of Sevoflurane |
— | — |
| SECONDARY Mean Number of Intubation Attempts |
1.26 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- Patients with at least one of the below criteria:
- Anatomic
- micrognathia - small mandible
- macroglossia - large tongue
- short or fixed neck
- anterior vocal cords
- Trauma - neck or face
- Burns - airway edema
- Infections - edema
- Retropharyngeal abscess
- Submandibular abscess
- epiglottitis
- laryngotracheobronchitis (croup)
- Neoplasms; e.g., laryngeal tumors
- Rheumatoid arthritis - temporomandibular joint (TMJ) immobility
- Diabetes mellitus
- Waxy skin - palm test
- Decreased functional residual capacity (FRC) - rapid desaturation (due to displaced diaphragm, increased closing capacity and small airway closure, increased oxygen consumption)
- airway closure in supine position
- Morbid obesity (body mass index [BMI] >35)
- Airway edema
- Laryngospasm
- Edentulous patients - indent cheeks.
- Patients willing to sign informed consent
Exclusion Criteria
- Patients with present use of opioids and/or narcotic dependent.
- Patients with known sensitivity to sevoflurane or to other halogenated agents.
- Patients with known or suspected genetic susceptibility to malignant hyperthermia.
- Alcohol addictive patients.
- Patients with Renal insufficiency (baseline serum creatinine greater than 1.5 mg/dL)
- Patient is a pregnant or breastfeeding female
Data sourced from ClinicalTrials.gov (NCT01749631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.