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Is magnesium sulfate an alternative with an analgesic and safety profile equivalent to dexmedetomidine as an adjuvant to ropivacaine in erector block in mastectomy?

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523152-31-00
Acronym
MAGDEX-MAS
Enrollment
62
Registered
2025-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Brief summary

Time in minutes between recovery from general anesthesia and the moment the patient requests the first rescue analgesia

Detailed description

total amount of rescue analgesic consumed in the postoperative period during the first 24 hours., 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., heart rate (HR) and mean arterial pressure (MAP), 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)., 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).

Interventions

DRUGRopivacaína B. Braun 10 mg/ml solución inyectable EFG
DRUGMAGNESIUM SULFATE
DRUGDEXMEDETOMIDINE

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Time in minutes between recovery from general anesthesia and the moment the patient requests the first rescue analgesia

Secondary

MeasureTime frame
total amount of rescue analgesic consumed in the postoperative period during the first 24 hours., 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., heart rate (HR) and mean arterial pressure (MAP), 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)., 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).

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026