Clinical trial NCT00723164: Premedication on Sevoflurane Induction
Official title: Low Dose Fentanyl/Midazolam Improves Sevoflurane Induction in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Sevoflurane induction
Premedication
laryngeal mask airway
Anesthesia, inhalation [E03.155.197.197]
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2008-07-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 5 minutes after the premedication, each 30 seconds until the insertion of laryngeal mask airway
Secondary outcomes:
measure: Participants' cardiorespiratory status
timeFrame: 5 minutes after the premedication, at each minutes for 10 minutes
measure: Patients' anxiety level
timeFrame: Before and after premedication and 24 hrs post op
measure: Adverses events
timeFrame: 5 minutes after the premedication until the end of laryngeal mask insertion
measure: Satisfaction
timeFrame: 24 hrs post op
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Pierre Drolet, MD, FRCPC
role: STUDY_DIRECTOR
affiliation: Université de Montréal
name: Sandra Lesage, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joo HS, Perks WJ. Sevoflurane versus propofol for anesthetic induction: a meta-analysis. Anesth Analg. 2000 Jul;91(1):213-9. doi: 10.1097/00000539-200007000-00040.
citation: Siddik-Sayyid SM, Aouad MT, Taha SK, Daaboul DG, Deeb PG, Massouh FM, Muallem MA, Baraka AS. A comparison of sevoflurane-propofol versus sevoflurane or propofol for laryngeal mask airway insertion in adults. Anesth Analg. 2005 Apr;100(4):1204-1209. doi: 10.1213/01.ANE.0000148166.29749.3B.
citation: Ganatra SB, D'Mello J, Butani M, Jhamnani P. Conditions for insertion of the laryngeal mask airway: comparisons between sevoflurane and propofol using fentanyl as a co-induction agent. A pilot study. Eur J Anaesthesiol. 2002 May;19(5):371-5. doi: 10.1017/s0265021502000601.
citation: 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. doi: 10.1097/00000539-199904000-00041.
citation: Hattori J, Yamakage M, Iwasaki S, Chen X, Tsujiguchi N, Namiki A. Usefulness of midazolam premedication for volatile induction of anesthesia in adults. J Anesth. 2001;15(2):117-9. doi: 10.1007/s005400170041. No abstract available.
citation: Nishiyama T, Matsukawa T, Yokoyama T, Hanaoka K. Rapid inhalation induction with 7% sevoflurane combined with intravenous midazolam. J Clin Anesth. 2002 Jun;14(4):290-5. doi: 10.1016/s0952-8180(02)00361-6.
citation: Sivalingam P, Kandasamy R, Madhavan G, Dhakshinamoorthi P. Conditions for laryngeal mask insertion. A comparison of propofol versus sevoflurane with or without alfentanil. Anaesthesia. 1999 Mar;54(3):271-6. doi: 10.1046/j.1365-2044.1999.00663.x.
citation: Nathan N, Vandroux D, Benrhaiem M, Marquet P, Preux PM, Feiss P. Low alfentanil target-concentrations improve hemodynamic and intubating conditions during induction with sevoflurane. Can J Anaesth. 2004 Apr;51(4):382-7. doi: 10.1007/BF03018244.
citation: Meaudre E, Boret H, Suppini A, Sallaberry M, Benefice S, Palmier B. Sufentanil supplementation of sevoflurane during induction of anaesthesia: a randomized study. Eur J Anaesthesiol. 2004 Oct;21(10):793-6. doi: 10.1017/s0265021504000079.
citation: Muzi M, Colinco MD, Robinson BJ, Ebert TJ. The effects of premedication on inhaled induction of anesthesia with sevoflurane. Anesth Analg. 1997 Nov;85(5):1143-8. doi: 10.1097/00000539-199711000-00034.
citation: Katoh T, Nakajima Y, Moriwaki G, Kobayashi S, Suzuki A, Iwamoto T, Bito H, Ikeda K. Sevoflurane requirements for tracheal intubation with and without fentanyl. Br J Anaesth. 1999 Apr;82(4):561-5. doi: 10.1093/bja/82.4.561.
citation: Inagaki Y, Sumikawa K, Yoshiya I. Anesthetic interaction between midazolam and halothane in humans. Anesth Analg. 1993 Mar;76(3):613-7. doi: 10.1213/00000539-199303000-00029.
citation: Ben-Shlomo I, abd-el-Khalim H, Ezry J, Zohar S, Tverskoy M. Midazolam acts synergistically with fentanyl for induction of anaesthesia. Br J Anaesth. 1990 Jan;64(1):45-7. doi: 10.1093/bja/64.1.45.
citation: Plastow SE, Hall JE, Pugh SC. Fentanyl supplementation of sevoflurane induction of anaesthesia. Anaesthesia. 2000 May;55(5):475-8. doi: 10.1046/j.1365-2044.2000.01268.x.
citation: 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. doi: 10.1111/j.1365-2044.1997.091-az0086.x.
citation: Siau C, Liu EH. Nitrous oxide does not improve sevoflurane induction of anesthesia in adults. J Clin Anesth. 2002 May;14(3):218-22. doi: 10.1016/s0952-8180(02)00349-5.
citation: 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. doi: 10.1097/00000539-199909000-00014.
citation: 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. doi: 10.1007/BF03018579.
citation: 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. doi: 10.1046/j.1365-2044.1999.00949.x.
citation: Nathan N, Bazin JE, Cros AM. [Inhalation induction]. Ann Fr Anesth Reanim. 2004 Sep;23(9):884-99. doi: 10.1016/j.annfar.2004.07.017. French.
citation: Kelly RE, Hartman GS, Embree PB, Sharp G, Artusio JF Jr. Inhaled induction and emergence from desflurane anesthesia in the ambulatory surgical patient: the effect of premedication. Anesth Analg. 1993 Sep;77(3):540-3. doi: 10.1213/00000539-199309000-00019.
citation: Pancaro C, Giovannoni S, Toscano A, Peduto VA. Apnea during induction of anesthesia with sevoflurane is related to its mode of administration. Can J Anaesth. 2005 Jun-Jul;52(6):591-4. doi: 10.1007/BF03015767.
citation: Joo HS, Perks WJ, Belo SE. Sevoflurane with remifentanil allows rapid tracheal intubation without neuromuscular blocking agents. Can J Anaesth. 2001 Jul-Aug;48(7):646-50. doi: 10.1007/BF03016197.
citation: Cardinal V, Martin R, Tetrault 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. doi: 10.1007/BF03018453. French.
citation: 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. doi: 10.1093/bja/81.6.994-a. No abstract available.
citation: 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.
citation: Le May S, Hardy JF, Taillefer MC, Dupuis G. Measurement of patient satisfaction. Anesth Analg. 1999 Jul;89(1):255. doi: 10.1097/00000539-199907000-00047. No abstract available.
citation: 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. doi: 10.1007/s12630-009-9150-6. Epub 2009 Jul 30.