SE OF THE ANESTHETIC NITROUS OXIDE FOR PAIN RELIEF IN DIFFERENT PROCEDURES IN GYNECOLOGY

Phase 1

• Conditions: Pain associated to hysteroscopy procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-005426-30-ES
• Lead Sponsor: FUNDACION PARA LA INVESTIGACION BIOMEDICA DEL HOSPITAL UNIVERSITARIO PRINCIPE DE ASTURIAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-18
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- Women over 18 years.
- Patients candidates for conducting hysteroscopy, referred from the gynecology clinics.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 297
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Patients with allergies or contraindications to the study drugs.
- Deficiency of vitamin B12 or folic acid documented and untreated.
- Neurological abnormalities unexplained and recent onset.
- Patients who are pregnant or who might become pregnant.
- Women breastfeeding.
- Patients treated with other depressants of the central nervous system such as opiates, benzodiazepines and other psychotropic drugs.
- Patients not fluent in Spanish language.
- Inability to grant informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified