Premedication on Sevoflurane Induction
- Registration Number
- NCT00723164
- Lead Sponsor
- Maisonneuve-Rosemont Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- ASA physical status I-II
- Minor elective surgery
- General anesthesia
- Gastroesophageal reflux
- Exhibited a body mass index > 32 kg/m2
- Took sedative or opioid drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FM Fentanyl and Midazolam 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. NaCl NaCl A 2.5 ml NaCL placebo (NaCl) IV, five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2.
- Primary Outcome Measures
Name Time Method 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. 5 minutes after the premedication, each 30 seconds until the insertion of laryngeal mask airway
- Secondary Outcome Measures
Name Time Method Participants' cardiorespiratory status 5 minutes after the premedication, at each minutes for 10 minutes Patients' anxiety level Before and after premedication and 24 hrs post op Adverses events 5 minutes after the premedication until the end of laryngeal mask insertion Satisfaction 24 hrs post op
Trial Locations
- Locations (1)
Hôpital Maisonneuve-Rosemont
🇨🇦Montréal, Quebec, Canada