Clinical Trials Register

Summary
EudraCT Number:	2014-002243-17
Sponsor's Protocol Code Number:	DEXCOM
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2014-06-09
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2014-002243-17

A.3

Full title of the trial

Conscious sedation for procedures in Dental and Minor Maxillofacial Surgery Unit: optimization of the dexmedetomidine dose (Dexdor®).

Sedación consciente para procedimientos de Unidad Dental y Cirugía Maxilofacial Menor: optimización de la dosis de dexmedetomidina (Dexdor®).

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Conscious sedation for procedures in Dental and Minor Maxillofacial Surgery Unit: optimization of the dexmedetomidine dose (Dexdor®).

Sedación consciente para procedimientos de Unidad Dental y Cirugía Maxilofacial Menor: optimización de la dosis de dexmedetomidina (Dexdor®).

A.4.1

Sponsor's protocol code number

DEXCOM

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Clínica Universidad de Navarra/Universidad de Navarra
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Orion Corporation
B.4.2	Country	Finland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clinica Universidad de Navarra
B.5.2	Functional name of contact point	UCICEC
B.5.3	Address:
B.5.3.1	Street Address	Avda. Pío XII, 36
B.5.3.2	Town/ city	Pamplona
B.5.3.3	Post code	31008
B.5.3.4	Country	Spain
B.5.4	Telephone number	34948255 4001144
B.5.5	Fax number	34948296 667
B.5.6	E-mail	ucicec@unav.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Dexdor
D.2.1.1.2	Name of the Marketing Authorisation holder	Orion Corporation
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Dexdor
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	DEXMEDETOMIDINE
D.3.9.1	CAS number	113775-47-6
D.3.9.4	EV Substance Code	SUB07037MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/kg/h milligram(s)/kilogram/hour
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.0002 to 0.0014
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Sedation for procedures in Dental and Minor Maxillofacial Surgery Unit

Unidad Dental y Cirugía Maxilofacial Menor

E.1.1.1

Medical condition in easily understood language

Sedation for procedures in Dental and Minor Maxillofacial Surgery Unit

Unidad Dental y Cirugía Maxilofacial Menor

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10054806
E.1.2	Term	Maxillofacial operation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the need of administering a loading dose of dexmedetomidine (Dexdor®) to obtain an adequate level of sedation, BIS 85-90 after 30min of drug administration and BIS 80-85 after 45min, for ambulant procedures in the Dental and Minor Maxillofacial Surgery Unit.

Valorar la necesidad de administrar una dosis de carga de dexmedetomidina (Dexdor?) para obtener un BIS de 85-90 tras 30min de la administración de la dosis de carga o placebo y 80-85 a partir de los 45min, para procedimientos de Unidad Dental y Cirugía Maxilofacial Menor en régimen ambulatorio.

E.2.2

Secondary objectives of the trial

- To evaluate the optimal maintenance dose of dexmedetomidine to achieve a satisfactory sedation during the procedure
- To perform a comparative analysis of possible hemodynamic changes (reflex bradycardia, hypertension...) depending on the administration of a loading dose
- To compare degrees of satisfaction, using questionnaires for the patient and the interventionist, about the administration of a loading dose and the maintenance dose administered
- To establish a relationship between the administration of the loading and maintenance dose with BIS levels observed during the procedure.
- To evaluate surgical stress index (SSI) during the procedure.
- To describe possible adverse or secondary effects during the use of dexmedetomidine for this type of interventions
- To evaluate the influence of the loading and maintenance doses on the time until discharge.

? Valorar la dosis de dexmedetomidina de mantenimiento óptima para alcanzar una sedación satisfactoria durante el procedimiento.
? Valorar los posibles cambios hemodinámicos en función de la administración o no de dosis de carga.
? Conocer el grado de satisfacción, mediante una encuesta para el paciente y el intervencionista, en función de la administración o no de dosis de carga y la dosis de mantenimiento administrada.
? Establecer una relación entre la administración o no de dosis de carga y dosis de mantenimiento con los niveles de BIS observados durante el procedimiento.
? Evaluación del índice de estrés quirúrgico (ISS) durante una sedación con dexmedetomidina.
? Descripción de posibles efectos adversos o secundarios durante el empleo de dexmedetomidina para este tipo de intervenciones.
? Valorar la influencia de la dosis de carga y mantenimiento en el tiempo necesario para al alta domiciliaria.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Ability to provide informed consent and express his desire to meet all protocol requirements during the study.
2. The patient should be able to meet with all requirements of the clinical trial.
3. Above 18 years of age.
4. A pregnancy test will be performed to women between 18 years old and menopause in order to rule out pregnancy unknown.
5. The patient requires sedation to carry out one of the Dental procedures and Maxillofacial Surgery Unit: Complex wisdom 4 tooth extraction, Dental implants with or without bone stimulation.
6. Individuals ASA I (healthy patient) or II (patient with a process mild systemic without limitations in daily activities.)

1. Capacidad para otorgar consentimiento informado y expresar su deseo de cumplir todos los requisitos del protocolo durante el periodo de estudio.
2. El/la paciente debe, en opinión del investigador, ser capaz de cumplir con todos los requerimientos del ensayo clínico.
3. El paciente deberá tener más de 18 años de edad.
4. Las mujeres en edad fértil entre 18 y la menopausia, se les realizará un test de embarazo para descartar posibles embarazos no conocidos.
5. El paciente requiere sedación para llevar acabo uno de los procedimientos de la Unidad Dental y de Cirugía Maxilofacial: extracción compleja de 4 cordales o colocación de implantes dentales, con o sin estimulación ósea.
6. Individuos ASA I (paciente sano) o II (paciente con un proceso sistémico leve sin limitaciones en las actividades diarias.)

E.4

Principal exclusion criteria

1. Dexmedetomidine hypersensitivity
2. HR < 45bpm. Most individuals who participate in the study will be youth or individuals with hypertension controlled with drugs decrease HR <60 bpm without any symptoms. So if the individual with HR>45bpm does not shows sign of low cardiac output, he will be considered candidates for the study.
3. Heart block grade 2-3 without pacemaker
4. Mean blood pressure < 60mmHg.
5. Severe stroke.
6. Pregnancy and breastfeeding

1. Antecedentes de hipersensibilidad a dexmedetomidina.
2. FC < 45lpm. La mayoría de los individuos que participarán en el estudio serán individuos jóvenes o con HTA controlada con fármacos que disminuyen FC < 60lpm (como betabloqueantes) sin ninguna sintomatología. Por lo tanto si el individuo no muestra ningún signo de bajo gasto cardiaco, se considerarán candidatos para el estudio a individuos con FC > 45lpm.
3. Bloqueo cardíaco en 2º o 3º grado sin marcapasos.
4. Presión arterial media < 60mmHg.
5. Paciente con enfermedad cerebrovascular grave.
6. Paciente embarazada o en período de lactancia.

E.5 End points

E.5.1

Primary end point(s)

- Administered loading dose: 0.5 µg kg-1, 0.2 µg kg-1 or placebo.
- Dexmedetomidine concentration required during the intervention to obtain an adequate level of sedation BIS 85-90 after 30min of drug administration, and BIS 80-85 after 45min, for ambulant procedures in the Dental and Minor Maxillofacial Surgery Unit.

? Dosis de carga administrada: 0.5 µg kg-1, 0.25 µg kg-1 o placebo.
? Dosis de dexmedetomidina necesaria para alcanzar un BIS 85-90 a partir de los 30min de la administración de la dosis de carga y un BIS entre 80-85 a partir de 45min del inicio del procedimiento.

E.5.1.1

Timepoint(s) of evaluation of this end point

- When administering the loading dose.
- After 30 min of the loading dose administration to reach a BIS 85-90 and 45 min from the start of the procedure to reach a BIS between 80-85.

? Al administrar la dosis de carga.
? A partir de los 30min de la administración de la dosis de carga para alcanzar un BIS 85-90 y a partir de 45min del inicio del procedimiento para alcanzar un BIS entre 80-85.

E.5.2

Secondary end point(s)

1. Demographic variables (sex, age, weight, BMI)
2. Patient-associated pathology (diabetes mellitus, hypertension, ischemic cardiopathy,...)
3. Type of performed procedure
4. Reasons for changing the maintenance dose
5. Monitored vital signs: cardiac frequency, blood pressure, respiratory frequency, EtCO2; SpO2.
6. Degree of analgesia obtained: SSI (surgical stress index)
7. Duration of the procedure.
8. Intra- and post-operative events: severe bradycardia (< 40bpm), syncopes, hypotensive episodes, nausea, ...
9. Recovery time and time until discharge.
10. Degree of patient satisfaction, using assessment questionnaire. To assess the degree of patient satisfaction after use of dexmedetomidine, in procedures of the Dental and Minor Maxillofacial Surgery Unit, we have adapted with minimal changes a questionnaire previously validated in a study on the effectiveness of midazolam for sedation in flexible bronchoscopy.
11. Degree of satisfaction of the surgical team, using assessment questionnaire.

? Variables demográficas (sexo, edad, peso, IMC).
? Patología asociada al paciente (DM, HTA, Cardiopatía isquémica,...).
? Tipo de procedimiento realizado.
? Causas que han motivado los cambios en la dosis de mantenimiento.
? Variables monitorizadas: FC; PANI; FR; EtCO2; SpO2.
? Valoración de analgesia obtenida: ISS (Indice de estrés quirúrgico)
? Duración del procedimiento.
? Eventos intra y postoperatorios: bradicardia severa (< 40 lpm), sincopes, episodio de hipotensión, náuseas,...
? Duración de recuperación y alta domiciliaria.
? Grado de satisfacción del paciente, mediante cuestionario de valoración. Para valorar el grado de satisfacción del paciente tras el uso de Dexmedetomidina en procedimientos de la Unidad Dental y Cirugía Maxilofacial Menor, hemos adaptado con mínimos cambios un cuestionario validado previamente en un estudio sobre la eficacia del midazolam para la sedación en la broncoscopia flexible.
? Grado de satisfacción del equipo quirúrgico, mediante cuestionario de valoración.

E.5.2.1

Timepoint(s) of evaluation of this end point

At different times throughout the study.

En distintos momentos a lo largo del estudio.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

UVUS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

124

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Ninguno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2014-10-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-09-30

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2020-03-02

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