In short
Clinical trials are investigating Magnesium Sulfate Heptahydrate in different hospital settings, mainly to see if it can improve patient outcomes and reduce symptoms or medicine use. These studies focus on safety and efficacy in adults having surgery, patients with severe headache, and patients with obesity undergoing bariatric surgery.
Key points
- Clinical trials of Magnesium Sulfate Heptahydrate are looking at different hospital uses, especially during surgery and for severe headache. The main Phase 3 studies include patients having lung resection with VATS, patients with refractory chronic cluster headache, and patients with obesity undergoing robotic bariatric surgery. Researchers are measuring outcomes such as morphine use, headache crisis frequency, and nausea scores. Some trials also track safety results, including treatment-emergent adverse events and serious adverse events. The study designs are interventional, so the treatment is actively given and compared with a control or another approach. Enrollment ranges from small to moderate groups, showing that these are focused clinical studies.
Trial overview
The trial data show several interventional studies that include Magnesium Sulfate Heptahydrate as part of the study treatment. The main focus is on how it performs in real clinical settings, especially surgery and severe headache care.
Most of the Magnesium Sulfate Heptahydrate studies in this set are Phase 3 trials, which are later-stage studies used to check how well a treatment works and how safe it is in larger groups. The studies are listed as interventional, meaning the researchers actively give a treatment and then measure the results.
Surgery studies
One authorised Phase 3 trial is studying patients having lung resection surgery using Video-Assisted Thoracic Surgery (VATS). The trial asks whether intravenous lidocaine and Magnesium Sulfate Heptahydrate during surgery can reduce morphine use in the first 24 hours after the operation.
This study plans to enroll 128 participants and uses morphine consumption as its primary outcome. For patients, this means the researchers want to know if the study treatment can lower the need for extra pain medicine after surgery.
Another authorised Phase 3 trial in the data looks at robotic bariatric surgery in patients with obesity, but it is currently suspended and does not appear to be a Magnesium Sulfate Heptahydrate-specific trial in the source data. It is included here because the intervention list contains Magnesium Sulfate Heptahydrate among other study drugs.
Headache study
The completed Phase 3 trial NCT04814381 studied people with refractory chronic cluster headache, which means a severe headache condition that had not improved with recommended treatments. The study tested a single infusion of ketamine combined with Magnesium Sulfate Heptahydrate against an active placebo group that received hydroxyzine.
The main outcome was the change in weekly frequency of headache crises during days 7 to 13 compared with the period before treatment. This tells patients that the trial was looking for fewer headache attacks after treatment, not just short-term symptom relief.
This study enrolled 90 participants and was designed as an interventional Phase 3 trial. The brief summary says the goal was to evaluate whether the infusion helped reduce headache crises in patients who were not relieved by currently recommended treatments.
Obesity and anesthesia study
The suspended Phase 3 ANGELO study is in patients with obesity undergoing robotic bariatric surgery. The study compares opioid-free general anesthesia with opioid-based general anesthesia to see whether it lowers postoperative nausea and vomiting.
Magnesium Sulfate Heptahydrate is listed among the study drugs in this trial, along with lidocaine, dexmedetomidine, and ketamine. The primary outcome is the Visual Analog Scale for Nausea (VAS-N), which is a patient score for how strong nausea feels.
This study planned to enroll 64 participants. Because the trial is suspended, it is not currently moving forward in the same way as the authorised studies.
Main endpoints being measured
The trials use endpoints, which are the main results researchers measure to answer the study question. In the lung surgery trial, the endpoint is morphine use in the first 24 postoperative hours.
In the chronic cluster headache trial, the endpoint is the change in weekly headache crisis frequency. In the bariatric surgery trial, the endpoint is nausea severity measured with the VAS-N score.
Some trials in the broader data also focus on safety, using outcomes such as treatment-emergent adverse events and serious adverse events. These are medical events that happen after treatment starts, and serious adverse events are the more severe ones.
Trial design, phase, and enrollment
All of the Magnesium Sulfate Heptahydrate studies shown here are interventional trials, so the treatment is actively given as part of the study plan. The studies are mainly Phase 3, with enrollment sizes ranging from 64 to 128 in the Magnesium Sulfate Heptahydrate-related trials listed above.
The target populations are very different, which shows that the trials are studying Magnesium Sulfate Heptahydrate in more than one clinical setting. These include surgical patients, patients with severe headache, and patients with obesity undergoing bariatric surgery.
The status of the trials also varies, with authorised, completed, and suspended studies in the data. This means some studies are active or approved, one has finished, and one is currently on hold.
Patient guide to key terms
Authorised means the study has been approved to move forward. Completed means the study has finished collecting data. Suspended means the study has been paused.
Intravenous infusion means a treatment is given through a vein over time. Intraoperative means during surgery, and postoperative means after surgery.
Active placebo means a control treatment that may cause some effects but is not the main study treatment. This helps researchers compare results more fairly in some trials.