Premedication on Sevoflurane Induction

This study has been completed.
Sponsor:
Information provided by:
Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT00723164
First received: July 24, 2008
Last updated: July 25, 2008
Last verified: July 2008

July 24, 2008
July 25, 2008
October 2005
December 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00723164 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Premedication on Sevoflurane Induction
Low Dose Fentanyl/Midazolam Improves Sevoflurane Induction in Adults

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anesthesia
  • 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
  • Drug: NaCl
    NaCl 0.9% 2.5 ml intravenous (IV), 5 minutes prior inhalation induction of anesthesia with sevoflurane.
  • 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.
    Intervention: Drug: Fentanyl and Midazolam
  • Placebo Comparator: NaCl
    A 2.5 ml NaCL placebo (NaCl) IV, five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2.
    Intervention: Drug: NaCl

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2005
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ASA physical status I-II
  • Minor elective surgery
  • General anesthesia

Exclusion Criteria:

  • Gastroesophageal reflux
  • Exhibited a body mass index > 32 kg/m2
  • Took sedative or opioid drugs.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00723164
05041
No
Sandra Lesage (resident), University of Montreal/Maisonneuve-Rosemont Hospital
Maisonneuve-Rosemont Hospital
Not Provided
Study Director: Pierre Drolet, MD, FRCPC Maisonneuve-Rosemont Hospital
Principal Investigator: Sandra Lesage, MD Université de Montréal
Maisonneuve-Rosemont Hospital
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP