Premedication on Sevoflurane Induction

July 25, 2008 updated by: Maisonneuve-Rosemont Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve-Rosemont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 minutes after the premedication, each 30 seconds until the insertion of laryngeal mask airway

Secondary Outcome Measures

Outcome Measure
Time Frame
Participants' cardiorespiratory status
Time Frame: 5 minutes after the premedication, at each minutes for 10 minutes
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
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
5 minutes after the premedication until the end of laryngeal mask insertion
Satisfaction
Time Frame: 24 hrs post op
24 hrs post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maisonneuve-Rosemont Hospital

Investigators

  • Study Director: Pierre Drolet, MD, FRCPC, Maisonneuve-Rosemont Hospital
  • Principal Investigator: Sandra Lesage, MD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (ESTIMATE)

July 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 28, 2008

Last Update Submitted That Met QC Criteria

July 25, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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