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
  Purpose

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.


Condition Intervention
Anesthesia
Drug: Fentanyl and Midazolam
Drug: NaCl

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: October 2005
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: NaCl
NaCl 0.9% 2.5 ml intravenous (IV), 5 minutes prior inhalation induction of anesthesia with sevoflurane.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00723164

Locations
Canada, Quebec
Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
Study Director: Pierre Drolet, MD, FRCPC Maisonneuve-Rosemont Hospital
Principal Investigator: Sandra Lesage, MD Université de Montréal
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sandra Lesage (resident), University of Montreal/Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT00723164     History of Changes
Other Study ID Numbers: 05041
Study First Received: July 24, 2008
Last Updated: July 25, 2008
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Maisonneuve-Rosemont Hospital:
Sevoflurane induction
Premedication
laryngeal mask airway
Anesthesia, inhalation [E03.155.197.197]

Additional relevant MeSH terms:
Midazolam
Fentanyl
Sevoflurane
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on July 29, 2014