Premedication on Sevoflurane Induction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00723164
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : July 28, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Fentanyl and Midazolam Drug: NaCl Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Dose Fentanyl/Midazolam Improves Sevoflurane Induction in Adults
Study Start Date : October 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Participants' cardiorespiratory status [ Time Frame: 5 minutes after the premedication, at each minutes for 10 minutes ]
  2. Patients' anxiety level [ Time Frame: Before and after premedication and 24 hrs post op ]
  3. Adverses events [ Time Frame: 5 minutes after the premedication until the end of laryngeal mask insertion ]
  4. Satisfaction [ Time Frame: 24 hrs post op ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00723164

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

Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sandra Lesage (resident), University of Montreal/Maisonneuve-Rosemont Hospital Identifier: NCT00723164     History of Changes
Other Study ID Numbers: 05041
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: July 28, 2008
Last Verified: July 2008

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

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