Premedication on Sevoflurane Induction

NCT ID: NCT00723164

Last Updated: 2008-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Anesthesia

Keywords

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Sevoflurane induction Premedication laryngeal mask airway Anesthesia, inhalation [E03.155.197.197]

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Fentanyl and Midazolam

Intervention Type DRUG

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

NaCl

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

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

NaCl

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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University of Montreal/Maisonneuve-Rosemont Hospital

Principal Investigators

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Pierre Drolet, MD, FRCPC

Role: STUDY_DIRECTOR

Maisonneuve-Rosemont Hospital

Sandra Lesage, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Locations

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Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
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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.

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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.

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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. doi: 10.1097/00000539-199904000-00041.

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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.

Reference Type RESULT
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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.

Reference Type RESULT
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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.

Reference Type RESULT
PMID: 10364865 (View on PubMed)

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.

Reference Type RESULT
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Reference Type RESULT
PMID: 15678734 (View on PubMed)

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.

Reference Type RESULT
PMID: 9356116 (View on PubMed)

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Reference Type RESULT
PMID: 10472223 (View on PubMed)

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.

Reference Type RESULT
PMID: 8452276 (View on PubMed)

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.

Reference Type RESULT
PMID: 2302375 (View on PubMed)

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.

Reference Type RESULT
PMID: 10792142 (View on PubMed)

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.

Reference Type RESULT
PMID: 9165957 (View on PubMed)

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.

Reference Type RESULT
PMID: 12031757 (View on PubMed)

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.

Reference Type RESULT
PMID: 10475291 (View on PubMed)

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.

Reference Type RESULT
PMID: 15625255 (View on PubMed)

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.

Reference Type RESULT
PMID: 10460554 (View on PubMed)

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.

Reference Type RESULT
PMID: 15471636 (View on PubMed)

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.

Reference Type RESULT
PMID: 8368553 (View on PubMed)

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.

Reference Type RESULT
PMID: 15983143 (View on PubMed)

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.

Reference Type RESULT
PMID: 11495870 (View on PubMed)

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.

Reference Type RESULT
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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.

Reference Type RESULT
PMID: 10211042 (View on PubMed)

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.

Reference Type RESULT
PMID: 11878707 (View on PubMed)

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.

Reference Type RESULT
PMID: 10389815 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19641980 (View on PubMed)

Other Identifiers

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05041

Identifier Type: -

Identifier Source: org_study_id