Clinical Trials Register

Summary
EudraCT Number:	2014-005156-26
Sponsor's Protocol Code Number:	PRIN-SUGAR-2014
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-01-26
Trial 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

2014-005156-26

A.3

Full title of the trial

Effects of neuromuscular block reversal with sugammadex vs neostigmine on postoperative respiratory outcomes after major abdominal surgery. A randomized controlled trial.

EFECTO DE LA REVERSION DEL BLOQUEO NEUROMUSCULAR CON SUGAMMADEX FRENTE A NEOSTIGMINA EN LA FUNCION PULMONAR POSTOPERATORIA. ESTUDIO ALEATORIZADO Y CONTROLADO

A.3.1

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

Effects of neuromuscular block reversal with sugammadex vs neostigmine on postoperative respiratory outcomes after major abdominal surgery. A randomized controlled trial.

EFECTO DE LA REVERSION DEL BLOQUEO NEUROMUSCULAR CON SUGAMMADEX FRENTE A NEOSTIGMINA EN LA FUNCION PULMONAR POSTOPERATORIA. ESTUDIO ALEATORIZADO Y CONTROLADO

A.3.2

Name or abbreviated title of the trial where available

Sugammadex vs neostigmine on postoperative respiratory outcomes after major abdominal surgery.

SUGAMMADEX FRENTE A NEOSTIGMINA EN LA FUNCION PULMONAR POSTOPERATORIA

A.4.1

Sponsor's protocol code number

PRIN-SUGAR-2014

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	Dr. Enrique Alday
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	Dr. Enrique Alday
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Servicio de Farmacología Clínica
B.5.2	Functional name of contact point	Manuel Román
B.5.3	Address:
B.5.3.1	Street Address	C/ Diego de León 62 Hospital Universitario de La Princesa
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28006
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34915202540
B.5.5	Fax number	+34915202540
B.5.6	E-mail	manuel.roman@salud.madrid.org

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Neostigmina Braun
D.2.1.1.2	Name of the Marketing Authorisation holder	Braun Medical, S.A.
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	Neostigmine
D.3.2	Product code	Reference
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	NEOSTIGMINE
D.3.9.1	CAS number	588-17-0
D.3.9.2	Current sponsor code	Reference
D.3.9.3	Other descriptive name	R
D.3.9.4	EV Substance Code	SUB03411MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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.IMP: 2
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	Bridion
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp And Dohme Ltd
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	Sugammadex
D.3.2	Product code	Test
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Bridion
D.3.9.2	Current sponsor code	Test
D.3.9.3	Other descriptive name	SUGAMMADEX
D.3.9.4	EV Substance Code	SUB26695
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients of both sexes proposed for major abdominal surgery under general anesthesia plus epidural

Pacientes de ambos sexos propuestos para cirugía mayor abdominal bajo anestesia general más epidural

E.1.1.1

Medical condition in easily understood language

Patients of both sexes proposed for major abdominal surgery under general anesthesia plus epidural

Pacientes de ambos sexos propuestos para cirugía mayor abdominal bajo anestesia general más epidural

E.1.1.2

Therapeutic area

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

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Assess differences in the decline in forced vital capacity (FVC) among patients receiving sugammadex or neostigmine to reverse neuromuscular blockade.

Evaluar las diferencias en el descenso en la capacidad vital forzada (CVF) entre los pacientes que reciben sugammadex o neostigmina para revertir el bloqueo neuromuscular.

E.2.2

Secondary objectives of the trial

Differences in the size of atelectasis measured by planimetry.
Differences in pO2 / FiO2 ratio in the first hour after surgery.
Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters

Diferencias en el tamaño de las atelectasias medidas por planimetría.
Diferencias en la relación pO2/FiO2 en la primera hora tras la intervención.
Explorar la precisión de la ecografía pulmonar para detectar atelectasias y su correlación con la pO2/FiO2, la radiografía de tórax y los parámetros espirométricos

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients who previously signed informed consent.
Patients undergoing one of the following interventions:
-Segmental hepatectomy, atypical or lobar.
-Whipple pancreaticoduodenectomy cephalic and type reconstruction.
-Pancreatic resection without reconstruction
-Splenectomy.
-Partial or total gastrectomy
Partial or total colectomy with or without reconstruction transit

Pacientes que firmen previamente el consentimiento informado.
Pacientes sometidos a alguna de las siguientes intervenciones:
-Hepatectomía segmentaria, atípica o lobar.
-Duodenopancreatectomía cefálica y reconstrucción tipo Whipple.
-Resecciones de páncreas sin reconstrucción
-Esplenectomía.
-Gastrectomía parcial o total
-Colectomía total o parcial con o sin reconstrucción de tránsito

E.4

Principal exclusion criteria

? Do not give your consent.
? Come to the recovery unit mechanical ventilation.
? Have hypersensitivity reactions to any of the study drugs.
? A history of severe asthma or moderate asthma treated.
? Have a history of pulmonary fibrosis or very severe COPD (grade IV ranking GOLD).
? Have had myocardial infarction or coronary occlusion the three months prior to surgery.
? Have Myasthenia Gravis.
? Please specify emergency surgery.
? neuromuscular blockade was performed with non-steroidal blockers do not require pharmacological reversal of blockade.
? Do not have an epidural catheter for postoperative pain control.

?No den su consentimiento.
?Lleguen a la unidad de reanimación bajo ventilación mecánica.
?Tengan reacciones de hipersensibilidad a alguna de la drogas del estudio.
?Tengan antecedentes de asma severo o asma moderado bajo tratamiento.
?Tengan antecedentes de Fibrosis pulmonar o EPOC muy severo (grado IV en la clasificación de GOLD).
?Hayan tenido infarto de miocardio u oclusión coronaria los tres meses previos a la cirugía.
?Tengan Miastenia Gravis.
?Precisen intervención quirúrgica urgente.
?Se realice el bloqueo neuromuscular con bloqueantes no esteroideos o no precisen la reversión farmacológica del bloqueo.
?No tengan un catéter epidural para el control del dolor postoperatorio.

E.5 End points

E.5.1

Primary end point(s)

The analysis of the primary endpoint were performed with the difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h).

El análisis de la variable principal se realizará con la diferencia entre la CVFb (basal) y la CFV1h (la primera hora) y sobre la diferencia entre la CVFb y la CVF24h. (capacidad vital forzada a las 24h).

E.5.1.1

Timepoint(s) of evaluation of this end point

difference between CVFb (basal) and CFV1h (the first time) and the difference between CVFb and CVF24h. (forced vital capacity at 24h).

la diferencia entre la CVFb (basal) y la CFV1h (la primera hora) y sobre la diferencia entre la CVFb y la CVF24h. (capacidad vital forzada a las 24h).

E.5.2

Secondary end point(s)

Differences in the size of atelectasis measured by planimetry.
Differences in the relationship pO2 / FiO2 in the first hour after surgery.
Explore the accuracy of ultrasound to detect pulmonary atelectasis and its correlation with pO2 / FiO2, chest radiography and spirometry parameters

E.5.2.1

Timepoint(s) of evaluation of this end point

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Ciego para terceros

blind for third person

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

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

Date on which the last subject completed last study visit (day of discharge).

Fecha en la que el último sujeto completa última visita del estudio (día del alta hospitalaria).

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

100

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

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

130

F.4.2

For a multinational trial

F.4.2.1

In the EEA

130

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)

Not Apply

No aplica

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

2015-05-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-11-27

P. End of Trial
P.	End of Trial Status	Completed

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