Premedication on Sevoflurane Induction

Overview

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.

Full Title of Study: “Low Dose Fentanyl/Midazolam Improves Sevoflurane Induction in Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2005

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • Placebo Comparator: NaCl
    • A 2.5 ml NaCL placebo (NaCl) IV, five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Participants’ cardiorespiratory status
    • Time Frame: 5 minutes after the premedication, at each minutes for 10 minutes
  • Patients’ anxiety level
    • Time Frame: Before and after premedication and 24 hrs post op
  • Adverses events
    • Time Frame: 5 minutes after the premedication until the end of laryngeal mask insertion
  • Satisfaction
    • Time Frame: 24 hrs post op

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maisonneuve-Rosemont Hospital
  • Provider of Information About this Clinical Study
    • Sandra Lesage (resident), University of Montreal/Maisonneuve-Rosemont Hospital
  • Overall Official(s)
    • Pierre Drolet, MD, FRCPC, Study Director, Maisonneuve-Rosemont Hospital
    • Sandra Lesage, MD, Principal Investigator, Université de Montréal

Citations Reporting on Results

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Joo HS, Perks WJ, Belo SE. Sevoflurane with remifentanil allows rapid tracheal intubation without neuromuscular blocking agents. Can J Anaesth. 2001 Jul-Aug;48(7):646-50. doi: 10.1007/BF03016197.

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Le May S, Hardy JF, Taillefer MC, Dupuis G. Measurement of patient satisfaction. Anesth Analg. 1999 Jul;89(1):255. doi: 10.1097/00000539-199907000-00047. No abstract available.

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