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Remifentanil for Moderate Sedation for Shoulder Reduction in the ED

Phase 2
Conditions
Anterior Shoulder Dislocation.
Glenohumeral Joint
Registration Number
IRCT2013011312115N1
Lead Sponsor
Vice chancellor for research, Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
42
Inclusion Criteria

INCLUSION CRITERIA: Those aged 18–64 years with anterior shoulder dislocation, requiring closed reduction with physical condition I (healthy and normal patients without previous medical history) and II (patients with mild systemic disease with no functional limitation) according to the classification system of American Society of Anesthesiologists (ASA) will be selected.
EXCLUSION CRITERIA: The exclusion criteria included age <18 years and >64 years; History of allergy to benzodiazepines and narcotics; Prolonged use of opioids; Alcohol usage; Sleep obstructive apnea syndrome; Maxillofacial malformations with high probability of failure in maintaining the airway; Pregnant patients; Anterior dislocation requiring referral to orthopedic operating room; Patients with severe trauma; Patients in septic shock; Patients with advanced Heart disease; Kidney failure; Pneumonia; Uncontrolled seizures; Patients not willing to participate in the study.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Pain Perception. Timepoint: During Intervention. Method of measurement: Visual Analog Scale 100mm.;Respiratory Adverse Events. Timepoint: During Intervention. Method of measurement: The need for supplemental oxygen, Ventilation with a bag-mask, Maneuver practices for maintaining the airway open, Insertion of airway, Respiratory stimulation, Respiratory depression with SpO2 <92% in any time of intravenous administration of the drug until hospital discharge.;Procedure Time. Timepoint: During Intervention. Method of measurement: From the begining of sedatiion till end of reduction.;Patient Consent. Timepoint: After Intervention. Method of measurement: Likert Scale.
Secondary Outcome Measures
NameTimeMethod
on Respiratory Adverse Events. Timepoint: During Intervention. Method of measurement: Dysphoria, Vomiting, Headache, Myoclonus, Nausea, Stiffness, Rash, Cough, Bronchospasm, Laryngospasm, Stridor, Apnea, Seizures, Rash, Restlessness, Aspiration.
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