Premedication on Sevoflurane Induction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Low Dose Fentanyl/Midazolam Improves Sevoflurane Induction in Adults

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Fentanyl and Midazolam
* Drug: NaCl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FM<br>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<br>* 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<br>|
| Placebo Comparator: NaCl<br>A 2.5 ml NaCL placebo (NaCl) IV, five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2. | Drug: NaCl<br>* NaCl 0.9% 2.5 ml intravenous (IV), 5 minutes prior inhalation induction of anesthesia with sevoflurane.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 5 minutes after the premedication, each 30 seconds until the insertion of laryngeal mask airway | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' cardiorespiratory status |  | 5 minutes after the premedication, at each minutes for 10 minutes | 
| Patients' anxiety level |  | Before and after premedication and 24 hrs post op | 
| Adverses events |  | 5 minutes after the premedication until the end of laryngeal mask insertion | 
| Satisfaction |  | 24 hrs post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sevoflurane induction, Premedication, laryngeal mask airway, Anesthesia, inhalation [E03.155.197.197]