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NCT05227716
Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia
Phase 4 trial testing Perioperative magnesium sulfate in Anesthesia and Analgesia in 104 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Instituto Mexicano del Seguro Social |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 104 |
| Start date | 1 October 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 July 2024 |
| Sites | 2 locations across Mexico |
Drugs / interventions tested
- Perioperative magnesium sulfate — full drug profile →
Conditions studied
- Anesthesia and Analgesia — all drugs for Anesthesia and Analgesia →
- Magnesium Sulfate — all drugs for Magnesium Sulfate →
Sponsor
Instituto Mexicano del Seguro Social — full company profile →
Who can join
18 and older, any sex, with Anesthesia and Analgesia or Magnesium Sulfate. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Magnesium sulfate (MgSO4) has multiple desirable effects in an anesthetic procedure, including modulation of the hemodynamic response to surgical stress, perioperative anesthetic and analgesic effect, potentiation of neuromuscular blockade, and central nervous system depression. MgSO4 is an antagonist of the N-methyl-d-aspartic acid (NMDA) receptor, therefore it produces an analgesic effect related to the prevention of central sensitization caused by peripheral tissue damage. Objective. To evaluate the perioperative clinical response to MgSO4 as an adjunct to anesthesia. Material and method. Randomized, triple-blind clinical trial that will include men and women over 18 years of age, scheduled for surgery under general or regional anesthesia. After accepting and signing the informed consent, all patients will be subjected to the same pre, trans and postoperative protocol and will be assigned to 2 groups according to the intravenous administration of MgSO4 (placebo and MgSO4). A brief preoperative medical history will be taken, a peripheral blood sample will be taken to determine preoperative serum Mg, the clinical effect of MgSO4 on trans and postoperative analgesia (EVAD), hemodynamic stability (blood pressure (BP) and heart rate ( HR)), motor and neuromuscular block time (Bromage and TOF), and recovery time. The presence of adverse reactions to anesthesia (nausea, vomiting, chills, pruritus, urinary retention, arrhythmias, laryngeal or bronchial spasm) and those secondary to the administration of Mg, SO4, as well as the total doses of all drugs used during the perioperative. The data will be analyzed in the SPSS software.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05227716
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05227716 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Instituto Mexicano del Seguro Social
- Last refreshed: 17 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05227716.
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