NCT03003377

Brief Summary

The study was designed to determine and compare the sevoflurane EC50 optimal concentration for laryngeal mask airway Supreme versus laryngeal mask airway ProSeal insertion during target-controlled infusion of remifentanil.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
Last Updated

December 29, 2016

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

November 15, 2016

Last Update Submit

December 28, 2016

Conditions

Sevoflurane

Keywords

SevofluraneRemifentanilLaryngeal mask supremelaryngeal mask proseal

Outcome Measures

Primary Outcomes (1)

  • To compare the the minimum alveolar anesthetic concentration (determined at 1 atmosphere, that prevents movement in 50% of patients to LMAS vs. LMAP insertion) of sevoflurane with simultaneous remifentanil infusion in adult patients.

    To compare the concentration of sevoflurane with concomitant remifentanil infusion required for LMAS insertion vs. the concentration of sevoflurane with concomitant remifentanil infusion required for LMAP insertion.

    The sevoflurane concentration is obtained during the insertion of the LMAS or LMAP in patients, after anesthesia induction

Secondary Outcomes (3)

  • Blood pressure in mmHg

    Baseline and every 3 minutes until 6 minutes after insertion of the LMAs

  • Heart rate in bpm,

    Before and after LMAs insertion (every minute until 6 minutes)

  • BIS data, number from 100 (awake) to 40-45 (anesthetic status)

    Before and after LMAs insertion (every minute until 6 minutes)

Study Arms (2)

Device: laryngeal mask supreme

EXPERIMENTAL

Determine the Sevoflurane concentration associate with remifentanil for the insertion of the laryngeal mask supreme

Device: laryngeal mask supreme

Device: laryngeal mask proseal

ACTIVE COMPARATOR

Determine the Sevoflurane concentration associate with remifentanil for insertion of the laryngeal mask ProSeal

Device: laryngeal mask proseal

Interventions

laryngeal mask supremeDEVICE

Sevoflurane was administered by facial mask with concomitant remifentanil administration (at an effect-site of 4 ng/ml). The LMAS was inserted according to the manufacturer's recommendations with the patient's head in the neutral position. After equilibrium the LMAS was inserted and secured according to the manufacturer's recommendations, without using muscle relaxants. A single measurement will be obtained from each patient. If the patient reacted with movement, a 1-2 mg/kg dose of Propofol was administered.

Device: laryngeal mask supreme
laryngeal mask prosealDEVICE

Sevoflurane was administered by facial mask with concomitant remifentanil administration (at an effect-site of 4 ng/ml).The LMAP was inserted according to the manufacturer's recommendations with the patient's head in the neutral position. After equilibrium the LMAP was inserted and secured according to the manufacturer's recommendations, without using muscle relaxants. A single measurement will be obtained from each patient. If the patient reacted with movement, a 1-2 mg/kg dose of Propofol was administered.

Device: laryngeal mask proseal

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I-II patients
  • Scheduled to ambulatory surgery
  • Need for general anaesthesia
  • General anaesthesia usually performed with laryngeal mask
  • Negative pregnancy test in women
  • Signed inform consent

You may not qualify if:

  • Patients with a potentially difficult airway (Mallampati III or IV, a limited mouth opening and/or cervical spine disease)
  • Patients with reactive airway disease
  • Signs of upper respiratory infection
  • Patients who had a risk of gastric aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Anestesia, Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Related Publications (1)

  • Monteserin-Matesanz C, Gonzalez T, Anadon-Baselga MJ, Zaballos M. Supreme laryngeal mask airway insertion requires a lower concentration of sevoflurane than ProSeal laryngeal mask airway insertion during target-controlled remifentanil infusion: a prospective randomised controlled study. BMC Anesthesiol. 2020 Jan 7;20(1):5. doi: 10.1186/s12871-019-0921-5.

    PMID: 31910822DERIVED

Study Officials

  • Maite López-Gil, MD, PhD

    Servicio de Anestesiología, Hospital General Universitario Gregorio Marañón

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

November 15, 2016

First Posted

December 28, 2016

Study Start

November 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 29, 2016

Record last verified: 2016-12

Locations

ES(1)