Propofol for Supreme LMA Insertion With and Without Remifentanil

NCT01974648 | Completed Phase 4

• 1 other identifier: FIBHGMECNC002-2011
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study were to determine the clinically required concentration of propofol for LMA Supreme insertion, and to examine to what extent remifentanil reduces the dose of propofol and improves conditions for it's insertion.

Conditions

Patients Requiring Ambulatory Surgery Under General Anesthesia

Keywords

Laryngeal Mask Airway Supreme; propofol; remifentanil; effective dose of intravenous propofol; ED50

Outcome Measures

Primary Outcomes (1)

• The concentration of propofol with and without remifentanil for insertion of the SLMA

  Comparison of he concentration of propofol with and without remifentanil for insertion of the SLMA

  at insertion of SLMA

Secondary Outcomes (5)

• changes in Systolic Blood Pressure, Diastolic Blood Pressure and Heart Rate

  basal and every 3 minutes until 6 minutes after insertion of the SLMA

• BIS

  before and after SLMA insertion(every min until min 6)

• Fibrescope evaluation

  after SLMA insertion

• blood pressure(Hypertension or hypotension)

  before and after SLMA insertion(every min until min 6)

• heart rate (tachycardia or bradycardia)

  before and after SLMA insertion(every min until min 6)

Study Arms (2)

propofol

ACTIVE COMPARATOR

In control group, propofol concentrations will start at 4 μg ml-1, with 0,5 μg ml-1 as the step size, with the coadministration of saline.

Drug: propofol

propofol and remifentanil

EXPERIMENTAL

In propofol-remifentanil group, propofol + remifentanil at a target-controlled infusion 5 ng/mL will be coadministered.

Drug: propofol and remifentanil

Interventions

propofol DRUG

propofol

propofol and remifentanil DRUG

propofol and remifentanil

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with a potentially difficult airway o (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

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead
• Ministry of Health, Spain: collaborator

Study Sites (1)

Hospital General Universitario Gregorio Marañon Servicio de Anestesiologia y Reanimación

Madrid, Madrid, 28007, Spain

Location

Related Publications (1)

• Zaballos M, Bastida E, Agusti S, Portas M, Jimenez C, Lopez-Gil M. Effect-site concentration of propofol required for LMA-Supreme insertion with and without remifentanil: a randomized controlled trial. BMC Anesthesiol. 2015 Oct 6;15:131. doi: 10.1186/s12871-015-0115-8.

  PMID: 26438179 DERIVED

MeSH Terms

Interventions

Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Matilde Zaballos, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: November 1, 2013
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

ES (1)