The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia (LMA)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Optimal Time of Insertion of Laryngeal Mask Airway With Propofol Induction|
- Ease of Mouth opening [ Time Frame: From Induction of general anesthesia to satisfactory LMA insertion ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
0 sec, 60 sec, 90 sec
LMA will be inserted at 0, 60, and 90 seconds after eyelash reflex disappears
Procedure: Insertion of Laryngeal Mask Airway
The LMA will be inserted at 0 sec, 60 sec. and 90 sec. after induction of general anesthesia
Other Name: Laryngeal Mask Airway
This is a randomized, controlled, blinded trial. Midazolam, 2 mg and fentanyl 1.0 µg/kg, would be given prior to induction with propofol, 2.5 mg/kg.
The investigator who does the induction of general anesthesia will also be responsible for the timekeeping. For this reason, it is not possible for this investigator to be blinded to randomization. The induction would conclude after loss of eyelash reflex (LER). At that point insertion of the LMA (#4 for females, #5 for males) will occur 0, 60 and 90 seconds after LER. The LMA will be lubricated with a water soluble gel and will be inserted with a deflated cuff according to the technique described by Brain.
The investigator who inserts the LMA (Inv1) will be in the operating room and blinded to randomization groups by not seeing the induction of general anesthesia. This investigator will insert the LMA only when called by the investigator who induces general anesthesia (Inv2). Inv1 will also grade ease of LMA insertion.
The primary outcome is Jaw opening at the time of LMA insertion, defined as full 1, partial 2, and nil 3.
Secondary outcomes include:
- Insertion of LMA (easy, difficult, impossible)
- Coughing or gagging (none, some, significant)
- Head or body movement (none, some, significant)
- Laryngospasm or airway obstruction (none, partial, total)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972491
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Pei-shan Zhao, MD,PhD||Tufts Medical Center|