Premedication on Sevoflurane Induction
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|ClinicalTrials.gov Identifier: NCT00723164|
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : July 28, 2008
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Drug: Fentanyl and Midazolam Drug: NaCl||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Low Dose Fentanyl/Midazolam Improves Sevoflurane Induction in Adults|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
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.
NaCl 0.9% 2.5 ml intravenous (IV), 5 minutes prior inhalation induction of anesthesia with sevoflurane.
- 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 ]
- Participants' cardiorespiratory status [ Time Frame: 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 ]
- Adverses events [ Time Frame: 5 minutes after the premedication until the end of laryngeal mask insertion ]
- Satisfaction [ Time Frame: 24 hrs post op ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723164
|Montréal, Quebec, Canada, H1T 2M4|
|Study Director:||Pierre Drolet, MD, FRCPC||Maisonneuve-Rosemont Hospital|
|Principal Investigator:||Sandra Lesage, MD||Université de Montréal|