Hospital Infanta Cristina boosts security for endoscopic explorations research.

-the objective is to reduce the incidence of adverse effects on the sedation to patients

-the study seeks to reduce the recovery time from the user, while maintaining the convenience and comfort

Madrid, January 2012.- El Hospital Universitario Infanta Cristina, belonging to the public network of the community of Madrid, a clinical trial aimed at improving safety in patients undergoing endoscopic explorations begin in 2012. The objective is to test if the simple numbness of the pharynx reduces the need for general anesthesia in the gastroscopias, avoiding possible adverse effects. The trial has been prepared by the Division of digestive endoscopy of Infanta Cristina.

The study seeks to refine the effectiveness of a drug (lidocaina) to reduce the possible adverse effects associated with significant dose of propofol, a drug widely used in the endoscopic sedation.
If the investigation confirms the effectiveness of the lidocaina, the benefits for patients may be multiple. According to the principal investigator of el ensayo, Felipe de la Morena, could avoid the use of substantial doses of propofol, reducing the incidence of side effects associated with this medicine, maintaining an optimal level of sedation in the user and with a significant comfort ”.

Also the patient’s recovery would be faster, and reduce the time needed for the discharge and thus increasing efficiency in the management of resources.

The project has a duration of six months and is expected that its findings be made public in September 2012. To carry it out was he recruited 120 users arising for the conduct of routine endoscopy. They will be divided into two groups: one of them will you be lidocaina, while the second will receive a placebo (inactive principle).

All these patients will previously evaluated for possible use of propofol, ensuring the highest levels of safety and comfort at all times during the test.

Anesthesiology and resuscitation and services of pharmacy of the Hospital Universitario Infanta Cristina, which made the administration of drugs and will collaborate in the control of results participate in the preparation of the research, and its subsequent development.

This initiative represents a significant innovation to propose a research whose results can open a way of intervention for patients with problems in the digestive higher and in need of diagnosis and treatment through endoscopy.

Techniques of the art

The project has the backing of the Infanta Cristina University Hospital Research Committee and the Committee on ethics and clinical research of the University Hospital of the Princess. Also its accreditation has been verified to the Spanish Agency of medicines and health products (AEMPS), and it has already been registered in the database of European clinical trials (EudraCT) and its American counterpart ClinicalTrials.gov.

Digestive service carries out an innovative work since the opening of the Hospital Infanta Cristina. Its practitioners have highlighted by the use of endoscopic techniques of last generation as the ecoendoscopia, which has resulted in a breakthrough in dealing with complex diseases of the digestive system with effective methods not invasive.

At the end of last September digestive Service undertook successfully the first drainage of pancreatic cystic lesion by carrying out a quistogastrostomía guided by ecoendoscopia.

In addition, and in collaboration with the General Surgery and diagnostic imaging services, Infanta Cristina has also incorporated intraoperative ultrasound, a technique that extends and enhances information from conventional ultrasound, to facilitate surgery.

Digestive services portfolio includes 40 types of scans and functional tests for diagnostic and therapeutic endoscopy, eRCP, urgent endoscopy, digestive ultrasound and diagnostic ecoendoscopia. The catalogue is very broad, integrating the gastroscopias, colonoscopies, diagnostic and therapeutic eRCP, placement of prosthesis biliopancreáticas or ultrasound doppler.