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Premedication on Sevoflurane Induction

Low Dose Fentanyl/Midazolam Improves Sevoflurane Induction in Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00723164
Enrollment
80
Registered
2008-07-28
Start date
2005-10-31
Completion date
2005-12-31
Last updated
2008-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Sevoflurane induction, Premedication, laryngeal mask airway, Anesthesia, inhalation [E03.155.197.197]

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.

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

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

DRUGNaCl

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

Sponsors

Maisonneuve-Rosemont Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime 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.5 minutes after the premedication, each 30 seconds until the insertion of laryngeal mask airway

Secondary

MeasureTime frame
Participants' cardiorespiratory status5 minutes after the premedication, at each minutes for 10 minutes
Patients' anxiety levelBefore and after premedication and 24 hrs post op
Adverses events5 minutes after the premedication until the end of laryngeal mask insertion
Satisfaction24 hrs post op

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026