NCT00723164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
Last Updated

July 28, 2008

Status Verified

July 1, 2008

Enrollment Period

2 months

First QC Date

July 24, 2008

Last Update Submit

July 25, 2008

Conditions

Anesthesia

Keywords

Sevoflurane inductionPremedicationlaryngeal mask airwayAnesthesia, inhalation [E03.155.197.197]

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

FM

ACTIVE COMPARATOR

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

NaCl

PLACEBO COMPARATOR

A 2.5 ml NaCL placebo (NaCl) IV, five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2.

Drug: NaCl

Interventions

Fentanyl and MidazolamDRUG

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

FM
NaClDRUG

NaCl 0.9% 2.5 ml intravenous (IV), 5 minutes prior inhalation induction of anesthesia with sevoflurane.

NaCl

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I-II
  • Minor elective surgery
  • General anesthesia

You may not qualify if:

  • Gastroesophageal reflux
  • Exhibited a body mass index \> 32 kg/m2
  • Took sedative or opioid drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (28)

  • 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.

    PMID: 10866915RESULT

  • 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.

    PMID: 15781547RESULT

  • 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.

    PMID: 12095019RESULT

  • 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.

    PMID: 10195546RESULT

  • 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.

    PMID: 14566537RESULT

  • 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.

    PMID: 12088814RESULT

  • 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.

    PMID: 10364865RESULT

  • 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.

    PMID: 15064269RESULT

  • 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.

    PMID: 15678734RESULT

  • 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.

    PMID: 9356116RESULT

  • 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.

    PMID: 10472223RESULT

  • 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.

    PMID: 8452276RESULT

  • 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.

    PMID: 2302375RESULT

  • 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.

    PMID: 10792142RESULT

  • 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.

    PMID: 9165957RESULT

  • 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.

    PMID: 12031757RESULT

  • 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.

    PMID: 10475291RESULT

  • 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.

    PMID: 15625255RESULT

  • 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.

    PMID: 10460554RESULT

  • 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.

    PMID: 15471636RESULT

  • 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.

    PMID: 8368553RESULT

  • 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.

    PMID: 15983143RESULT

  • 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.

    PMID: 11495870RESULT

  • 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.

    PMID: 15470169RESULT

  • 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.

    PMID: 10211042RESULT

  • 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.

    PMID: 11878707RESULT

  • 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.

    PMID: 10389815RESULT

  • 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.

    PMID: 19641980DERIVED

MeSH Terms

Interventions

FentanylMidazolam

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pierre Drolet, MD, FRCPC

    Maisonneuve-Rosemont Hospital

    STUDY DIRECTOR

  • Sandra Lesage, MD

    Université de Montréal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

October 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

July 28, 2008

Record last verified: 2008-07

Locations

CA(1)