Premedication on Sevoflurane Induction
The goal of this study was to investigate the effects of fentanyl-midazolam premedication during sevoflurane induction pertaining to time to loss of eyelash reflex (LER), time and conditions of insertion of proseal laryngeal mask airway (PLMA), as well as cardio-respiratory data. Participants' anxiety level was also evaluated.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Low Dose Fentanyl/Midazolam Improves Sevoflurane Induction in Adults|
- Impact of administering a combination of low doses of IV fentanyl and midazolam on time to loss of consciousness, and time of insertion of a laryngeal mask airway during sevoflurane induction. [ Time Frame: 5 minutes after the premedication, each 30 seconds until the insertion of laryngeal mask airway ] [ Designated as safety issue: No ]
- Participants' cardiorespiratory status [ Time Frame: 5 minutes after the premedication, at each minutes for 10 minutes ] [ Designated as safety issue: No ]
- Patients' anxiety level [ Time Frame: Before and after premedication and 24 hrs post op ] [ Designated as safety issue: No ]
- Adverses events [ Time Frame: 5 minutes after the premedication until the end of laryngeal mask insertion ] [ Designated as safety issue: Yes ]
- Satisfaction [ Time Frame: 24 hrs post op ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||December 2005|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
Active Comparator: FM
Premedication consisting of fentanyl 0.6 ug/kg and midazolam 9 ug/kg (FM), five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2.
Drug: Fentanyl and Midazolam
A combination of fentanyl 0.6 ug/kg and midazolam 9 ug/kg, to which NaCl was added to obtain a volume of 2.5 mL (group FM) injected IV, 5 minutes prior inhalation induction of anesthesia with sevoflurane
Placebo Comparator: NaCl
A 2.5 ml NaCL placebo (NaCl) IV, five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2.
NaCl 0.9% 2.5 ml intravenous (IV), 5 minutes prior inhalation induction of anesthesia with sevoflurane.
Eighty adult patients undergoing minor surgery were randomized in a double-blind fashion. Each group received either a NaCL placebo (NaCl), or a premedication consisting of fentanyl 0,6 ug/kg and midazolam 9 ug/kg (FM), five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2. Times to LER and LMA insertion were recorded. Adverse events were also noted. Systolic blood pressure (sBP), heart rate (HR), respiratory rate (RR) and tidal volume (Vt) were recorded at one-minute intervals. End-tidal sevoflurane (EtSevo) and end-tidal CO2 (EtCO2) were noted immediately following LMA insertion. Anxiety levels (0-10 verbal scale) were registered before and after premedication. Patients were contacted 24 hours postoperatively and were asked if they remembered the mask being applied to their face.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723164
|Montréal, Quebec, Canada, H1T 2M4|
|Study Director:||Pierre Drolet, MD, FRCPC||Maisonneuve-Rosemont Hospital|
|Principal Investigator:||Sandra Lesage, MD||Université de Montréal|