Phase 4
N=100
Airway Responses During Desflurane Anesthesia Via a Laryngeal Mask Airway: Effects of Fentanyl Pretreatment
Administration Site Reaction
Bottom Line
View on ClinicalTrials.gov: NCT01277861 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Movement — 8; 24 Participants, number
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fentanyl (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Movement |
8; 24 | — |
| SECONDARY Apnea |
46; 30 | — |
| SECONDARY Coughing |
1; 6 | — |
Summary
The investigators plan to test the hypothesis that pretreatment with fentanyl prior to induction of anesthesia would result in reduce the incidence of movements and airway responses to desflurane in patients breathing spontaneously through a laryngeal mask airway (LMA). The primary aim of this study is to assess the effect of fentanyl pretreatment on the incidence of movement during induction of anesthesia. Secondary aim of the study is to evaluate the effects of titration of fentanyl according to the respiratory rate on the incidence of intraoperative respiratory events such as coughing, breath holding and laryngospasm.
Eligibility Criteria
Inclusion Criteria
- 18-64 years of age
- Subjects scheduled for elective superficial and peripheral surgery of less than 2 h duration (e.g., hernia surgery, breast surgery, upper or lower limb surgery, superficial abdominal/chest wall surgery [i.e., lipoma], minor gynecological procedures [i.e., hysteroscopy])
Exclusion Criteria
- obesity (body mass index >30)
- pregnancy
- history of gastroesophageal reflux, hiatal hernia, significant cardiovascular, pulmonary (e.g., reactive airway disease), hepatic, renal, neurologic, metabolic, and endocrine disease
- history of alcohol and drug abuse
- requiring tracheal intubation.
Data sourced from ClinicalTrials.gov (NCT01277861). 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.