CLINICAL TRIAL TO DETERMINE HOW A TYPE OF MAGNESIUM SULPHATE ANALGESIA WORKS IN ARTHROSCOPIC KNEE SURGERY

Phase 1

• Conditions: Pain in arthroscopic anterior cruciate ligament reconstruction surgery.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-002712-30-ES
• Lead Sponsor: FUNDACIÓN PÚBLICA ANDALUZA PROGRESO Y SALUD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-29
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

- Patients scheduled for anterior cruciate ligament reconstruction surgery via arthroscopy.
- ASA I and II patients of both sexes.
- Age between 18 and 60 years.
- Signed informed consent form agreeing to participate in the study.
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 131
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- ASA III or IV patients.
- Patients with expected difficult airway.
- Patients with the presence of predictive criteria for failed ventilation with supraglottic devices.
- Allergy or intolerance to local anaesthetics, morphine or derivatives, magnesium sulphate.
- Diabetes mellitus with last control of glycosylated haemoglobin greater than 7%.
- Patients with neuromuscular diseases.
- Patients with previous treatment with corticoids or calcium antagonists.
- Patients with difficulty in understanding the information related to the study and in collaborating in the assessment of pain.
- Patients with major psychiatric pathology in DSM-V.
- Pregnancy and/or breastfeeding.

Study & Design

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