Premedication on Sevoflurane Induction

Sponsor

Maisonneuve-Rosemont Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00723164

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

39.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Oct 1, 2005

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 1, 2005

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Maisonneuve-Rosemont	Montréal	Quebec	Canada	H1T 2M4

Sponsors and Collaborators

Maisonneuve-Rosemont Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00723164

Other Study ID Numbers:

05041

First Posted:

Jul 28, 2008

Last Update Posted:

Jul 28, 2008

Last Verified:

Jul 1, 2008

Keywords provided by , ,

Sevoflurane induction

Premedication

laryngeal mask airway

Anesthesia, inhalation [E03.155.197.197]

Additional relevant MeSH terms:

Fentanyl

Midazolam

Study Results

No Results Posted as of Jul 28, 2008