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AnesthesiaNCT00723164

Premedication on Sevoflurane Induction

A study testing Fentanyl and Midazolam and NaCl in people with Anesthesia, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Anesthesia
What is being tested?
Fentanyl and Midazolam and NaCl
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteCanada
Study dates
Oct 2005to Dec 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hôpital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Anesthesia
Being tested
Fentanyl and Midazolam, NaCl
Keywords
Sevoflurane induction, Premedication, laryngeal mask airway, Anesthesia, inhalation [E03.155.197.197]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • NaClDrug

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

Study groups in NCT00723164
Study groupRoleWhat they receive
FMActive comparatorPremedication 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.
Receives: Drug: Fentanyl and Midazolam
NaClPlacebo comparatorA 2.5 ml NaCL placebo (NaCl) IV, five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2.
Receives: Drug: NaCl

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 minutes after the premedication, each 30 seconds until the insertion of laryngeal mask airway

Secondary outcomes (4)

  1. Participants' cardiorespiratory status

    Measured: 5 minutes after the premedication, at each minutes for 10 minutes

  2. Patients' anxiety level

    Measured: Before and after premedication and 24 hrs post op

  3. Adverses events

    Measured: 5 minutes after the premedication until the end of laryngeal mask insertion

  4. Satisfaction

    Measured: 24 hrs post op

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2008 (estimated)
  2. Study startOct 2005
  3. Primary completionDec 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00723164
Sponsor's protocol ID
05041
Status last verified
Jul 2008
First submitted
24 Jul 2008
Last updated
28 Jul 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10866915

  • 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.

    PubMed 15781547

  • 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.

    PubMed 12095019

  • 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.

    PubMed 10195546

  • 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.

    PubMed 14566537

  • 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.

    PubMed 12088814

  • 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.

    PubMed 10364865

  • 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.

    PubMed 15064269

  • 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.

    PubMed 15678734

  • 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.

    PubMed 9356116

  • 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.

    PubMed 10472223

  • 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.

    PubMed 8452276

  • 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.

    PubMed 2302375

  • 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.

    PubMed 10792142

  • 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.

    PubMed 9165957

Questions about this trial

What is this clinical trial studying?

A study testing Fentanyl and Midazolam and NaCl in people with Anesthesia, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00723164, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2008.

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Premedication on Sevoflurane Induction (NCT00723164) | AzTrials