NCT02048293

Brief Summary

Unbranded drug molecules are produced after the patent of a given drug has expired. Unbranded molecules of Remifentanil have been marketed in Colombia, and several reports by anesthesiologist indicate that there are differences in the physiologic response of patients to these molecules. The investigators hypothesized that unbranded molecules of remifentanil require higher doses to obtain desired physiological responses as compared to the branded molecule.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Oct 2012

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, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

January 23, 2014

Last Update Submit

January 28, 2014

Conditions

Pain

Keywords

remifentanilpropofolpharmacodynamictotal intravenous anesthesiaorotracheal intubationheart ratemean arterial pressureCooper intubation condition score

Outcome Measures

Primary Outcomes (1)

  • Composite outcome of heart rate or mean arterial pressure difference before and after tracheal intubation

    Heart rate measured with EKG. Mean arterial pressure measured with automatic blood pressure cuff.

    Average of 5 minutes

Secondary Outcomes (1)

  • Cooper intubation condition score

    Measured during tracheal intubation, average of 30 seconds

Study Arms (3)

Group O

ACTIVE COMPARATOR

Remifentanyl innovative molecule = Ultiva®

Drug: Remifentanyl, Ultiva®Drug: Fada Remifentanilo

Group A

ACTIVE COMPARATOR

Remifentanyl comparator A = Remifentanil Laboratorios Chalver de Colombia S.A.

Drug: Remifentanil Laboratorios Chalver de Colombia S.A.Drug: Fada Remifentanilo

Group B

ACTIVE COMPARATOR

Remifentanyl comparator B = Fada Remifentanilo

Drug: Remifentanyl, Ultiva®Drug: Remifentanil Laboratorios Chalver de Colombia S.A.

Interventions

Remifentanyl, Ultiva®DRUG

Anesthetic induction for orotracheal intubation. Group O

Group BGroup O
Remifentanil Laboratorios Chalver de Colombia S.A.DRUG

Anesthetic induction for orotracheal intubation. Group A

Group AGroup B
Fada RemifentaniloDRUG

Anesthetic induction for orotracheal intubation. Group B

Group AGroup O

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients requiring orotracheal intubation
  • years old
  • Body mass index \<31 kg/m2
  • Written informed consent

You may not qualify if:

  • Pregnancy
  • Risk of difficult airway
  • History of opioid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose

Bogota, Cundinamarca, 11001000, Colombia

Location

Related Publications (3)

  • Kwak HJ, Min SK, Kim DH, Kang M, Kim JY. Effect-site concentration of remifentanil for nasotracheal versus orotracheal intubation during target-controlled infusion of propofol. J Int Med Res. 2011;39(5):1816-23. doi: 10.1177/147323001103900524.

    PMID: 22117982BACKGROUND

  • Lysakowski C, Dumont L, Pellegrini M, Clergue F, Tassonyi E. Effects of fentanyl, alfentanil, remifentanil and sufentanil on loss of consciousness and bispectral index during propofol induction of anaesthesia. Br J Anaesth. 2001 Apr;86(4):523-7. doi: 10.1093/bja/86.4.523.

    PMID: 11573626BACKGROUND

  • Coskun D, Celebi H, Karaca G, Karabiyik L. Remifentanil versus fentanyl compared in a target-controlled infusion of propofol anesthesia: quality of anesthesia and recovery profile. J Anesth. 2010 Jun;24(3):373-9. doi: 10.1007/s00540-010-0898-1. Epub 2010 Mar 13.

    PMID: 20229001BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • luis e reyes, professor

    fundacion universitaria de ciencias de la salud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician, Anesthesiologist, Intensive Care Specialist, Professor Fundación Universitaria de Ciencias de la Salud, Hospital de San José, Bogotá D.C.

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 29, 2014

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

CO(1)