| July 24, 2008 |
| July 25, 2008 |
| October 2005 |
| December 2005 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00723164 on ClinicalTrials.gov Archive Site |
- Participants' cardiorespiratory status [ Time Frame: 5 minutes after the premedication, at each minutes for 10 minutes ] [ Designated as safety issue: No ]
- Patients' anxiety level [ Time Frame: Before and after premedication and 24 hrs post op ] [ Designated as safety issue: No ]
- Adverses events [ Time Frame: 5 minutes after the premedication until the end of laryngeal mask insertion ] [ Designated as safety issue: Yes ]
- Satisfaction [ Time Frame: 24 hrs post op ] [ Designated as safety issue: No ]
|
| Same as current |
| Not Provided |
| Not Provided |
| |
| Premedication on Sevoflurane Induction |
| Low Dose Fentanyl/Midazolam Improves Sevoflurane Induction in Adults |
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. |
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. |
| Interventional |
| Not Provided |
Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Anesthesia |
- 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
- Drug: NaCl
NaCl 0.9% 2.5 ml intravenous (IV), 5 minutes prior inhalation induction of anesthesia with sevoflurane.
|
- 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.
Intervention: Drug: Fentanyl and Midazolam
- Placebo Comparator: NaCl
A 2.5 ml NaCL placebo (NaCl) IV, five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2.
Intervention: Drug: NaCl
|
- Joo HS, Perks WJ. Sevoflurane versus propofol for anesthetic induction: a meta-analysis. Anesth Analg. 2000 Jul;91(1):213-9.
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- Ti LK, Chow MY, Lee TL. Comparison of sevoflurane with propofol for laryngeal mask airway insertion in adults. Anesth Analg. 1999 Apr;88(4):908-12.
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- Plastow SE, Hall JE, Pugh SC. Fentanyl supplementation of sevoflurane induction of anaesthesia. Anaesthesia. 2000 May;55(5):475-8.
- Hall JE, Stewart JI, Harmer M. Single-breath inhalation induction of sevoflurane anaesthesia with and without nitrous oxide: a feasibility study in adults and comparison with an intravenous bolus of propofol. Anaesthesia. 1997 May;52(5):410-5.
- Siau C, Liu EH. Nitrous oxide does not improve sevoflurane induction of anesthesia in adults. J Clin Anesth. 2002 May;14(3):218-22.
- Philip BK, Lombard LL, Roaf ER, Drager LR, Calalang I, Philip JH. Comparison of vital capacity induction with sevoflurane to intravenous induction with propofol for adult ambulatory anesthesia. Anesth Analg. 1999 Sep;89(3):623-7.
- Yogendran S, Prabhu A, Hendy A, McGuire G, Imarengiaye C, Wong J, Chung F. Vital capacity and patient controlled sevoflurane inhalation result in similar induction characteristics. Can J Anaesth. 2005 Jan;52(1):45-9.
- Baker CE, Smith I. Sevoflurane: a comparison between vital capacity and tidal breathing techniques for the induction of anaesthesia and laryngeal mask airway placement. Anaesthesia. 1999 Sep;54(9):841-4.
- Nathan N, Bazin JE, Cros AM. [Inhalation induction] Ann Fr Anesth Reanim. 2004 Sep;23(9):884-99. Review. French.
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- Cardinal V, Martin R, Tétrault JP, Colas MJ, Gagnon L, Claprood Y. [Severe bradycardia and asystole with low dose sufentanil during induction with sevoflurane: a report of three cases] Can J Anaesth. 2004 Oct;51(8):806-9. French.
- Wang J, Winship S, Russell G. Induction of anaesthesia with sevoflurane and low-dose remifentanil: asystole following laryngoscopy. Br J Anaesth. 1998 Dec;81(6):994-5. No abstract available.
- Kurdi O, Deleuze A, Marret E, Bonnet F. Asystole during anaesthetic induction with remifentanil and sevoflurane. Br J Anaesth. 2001 Dec;87(6):943. No abstract available.
- Le May S, Hardy JF, Taillefer MC, Dupuis G. Measurement of patient satisfaction. Anesth Analg. 1999 Jul;89(1):255. No abstract available.
- Lesage S, Drolet P, Donati F, Racine S, Fortier LP, Audy D. Low-dose fentanyl-midazolam combination improves sevoflurane induction in adults. Can J Anaesth. 2009 Oct;56(10):733-9. Epub 2009 Jul 30.
|
| |
| Completed |
| 80 |
| December 2005 |
| December 2005 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Canada |
| |
| NCT00723164 |
| 05041 |
| No |
| Sandra Lesage (resident), University of Montreal/Maisonneuve-Rosemont Hospital |
| Maisonneuve-Rosemont Hospital |
| Not Provided
| Study Director: |
Pierre Drolet, MD, FRCPC |
Maisonneuve-Rosemont Hospital |
|
| Principal Investigator: |
Sandra Lesage, MD |
Université de Montréal |
|
|
| Maisonneuve-Rosemont Hospital |
| July 2008 |