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Completed

NCT Number: NCT00723164

Premedication on Sevoflurane Induction

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.

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Key information

Conditions

Anesthesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fentanyl and midazolam

Drug

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

NaCl

Drug

NaCl 0.9% 2.5 ml intravenous (IV), 5 minutes prior inhalation induction of anesthesia with sevoflurane.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Registry information

Official study title

Low Dose Fentanyl/Midazolam Improves Sevoflurane Induction in Adults

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jul 28, 2008
Registry last updated
Jul 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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