DEXMEDETOMIDINE for Breast cancer

Inclusion criteria

• {"criterion_text":"- • Patients aged 18 to 75 years scheduled for elective mastectomy under general anesthesia"}
• {"criterion_text":"- • ASA I-III patients"}
• {"criterion_text":"- • No contraindications for locoregional anesthesia"}

Exclusion criteria

• {"criterion_text":"- • Allergy to study drugs or local anesthetics."}
• {"criterion_text":"- • Uncooperative patients."}
• {"criterion_text":"- • Body mass index (BMI) > 35 kg/m²."}
• {"criterion_text":"- • Coagulopathy or bleeding disorder."}
• {"criterion_text":"- • Pre-existing bradycardia or cardiac conduction block."}
• {"criterion_text":"- • Psychiatric illness."}
• {"criterion_text":"- • Pregnancy."}
• {"criterion_text":"- • Injection site infection."}
• {"criterion_text":"- • Patients receiving α-adrenergic agonists or antiplatelet agents."}
• {"criterion_text":"- • Chronic opioid use."}

Primary endpoints

• {"endpoint_text":"- Time in minutes between recovery from general anesthesia and the moment the patient requests the first rescue analgesia","definition_or_measurement_approach":"Measured as the time interval in minutes from recovery from general anesthesia to the time of the first request for rescue analgesia (primary endpoint translation provided in record)."}

Secondary endpoints

• {"endpoint_text":"- total amount of rescue analgesic consumed in the postoperative period during the first 24 hours.","definition_or_measurement_approach":"Total rescue analgesic consumption measured during the first 24 postoperative hours."}
• {"endpoint_text":"- Pain level using the validated Visual Analog Scale (VAS) (0 = no pain, 10 = maximum imaginable pain). VAS scores will be recorded at time 0, which is when the patient arrives at the PACU, and subsequently at 2, 4, 8, 10, and 24 hours.","definition_or_measurement_approach":"Pain intensity measured with VAS (0-10) at PACU arrival (time 0) and at 2, 4, 8, 10 and 24 hours postoperatively."}
• {"endpoint_text":"- heart rate (HR) and mean arterial pressure (MAP)","definition_or_measurement_approach":"Hemodynamic parameters HR and MAP monitored to assess incidence of bradycardia and hypotension."}
• {"endpoint_text":"- incidence of adverse effects such as nausea, vomiting, bradycardia (HR < 60 bpm), hypotension (SBP < 90 mmHg or < 20% of baseline), respiratory depression, pruritus, and any complications related to the block (e.g., vascular puncture, nerve damage, pneumothorax, local anesthetic toxicity).","definition_or_measurement_approach":"Adverse events collected and incidence recorded; bradycardia defined as HR < 60 bpm; hypotension defined as SBP < 90 mmHg or < 20% of baseline."}
• {"endpoint_text":"- Patient satisfaction with postoperative pain management will be assessed using a satisfaction scale of 0 to 100 points (0 = Very dissatisfied with the analgesia provided by the treatment and 100 = totally satisfied with the analgesia provided by the treatment).","definition_or_measurement_approach":"Patient satisfaction measured on a 0–100 scale where 0 = very dissatisfied and 100 = totally satisfied."}

Spain

Earliest CTIS Part Ii Submission Date

23-09-2025

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

217

Number Of Sites

1

Number Of Participants

62

Primary sponsor

Full Name

Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain