Remimazolam vs Dexmedetomidine for Sedation During Cesarean Delivery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two sedation drugs, remimazolam and dexmedetomidine, to determine which is more effective for women undergoing scheduled cesarean delivery. The goal is to identify which drug provides effective sedation with fewer side effects during spinal or epidural anesthesia. Women who are at least 37 weeks pregnant and scheduled for a cesarean delivery may be eligible to participate. As a Phase 4 trial, this research aims to understand how these FDA-approved drugs can benefit more patients, contributing to improved sedation options for future cesarean deliveries.
What is the safety track record for these treatments?
Previous studies have shown that remimazolam is safe for use in sedation. It generally has less impact on blood pressure and heart rate compared to other sedatives. Research also shows it effectively achieves the desired level of sedation, with fewer side effects like low blood pressure and slow heart rate.
Dexmedetomidine, another sedative, can sometimes affect heart rate and blood pressure. While effective, these possible effects should be considered.
Both treatments have been researched for their safety and effectiveness. Remimazolam is particularly noted for its quick onset and recovery times, which can benefit patients undergoing a cesarean delivery.12345Why are researchers enthusiastic about this study treatment?
Remimazolam is unique because it offers a new approach to sedation during cesarean deliveries by providing rapid onset and quick recovery times, which can be especially beneficial in time-sensitive procedures. Unlike standard sedatives like midazolam and propofol, remimazolam is metabolized quickly by the body, reducing the risk of prolonged sedation and potential side effects. Researchers are excited because its fast action and predictable recovery profile could enhance patient comfort and safety during and after the procedure. Meanwhile, dexmedetomidine, known for its sedative properties with minimal respiratory depression, offers an alternative that may lead to a smoother sedation experience compared to other options.
What evidence suggests that this trial's treatments could be effective for sedation during cesarean delivery?
This trial will compare the effectiveness of remimazolam and dexmedetomidine for sedation during cesarean deliveries. Research has shown that remimazolam effectively keeps patients calm and comfortable during these procedures. It eases patient anxiety, reduces nausea and vomiting, and succeeds in over 98% of cases. Patients also wake up faster and feel clear-headed after using remimazolam.
Dexmedetomidine, which participants in this trial may receive, is another option known for its calming effects and is commonly used in medical procedures. It provides steady and calm sedation with little risk of breathing problems. Both treatments have shown promising results for safely calming patients during procedures like cesarean deliveries.35678Who Is on the Research Team?
Benjamin Hyers, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine
Are You a Good Fit for This Trial?
This trial is for pregnant women aged 18 or older, at least 37 weeks along, who are scheduled for a cesarean delivery and need spinal or epidural anesthesia. Those allergic to the study drugs, under 18, less than 37 weeks pregnant, or with chronic benzodiazepine use can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravenous remimazolam or dexmedetomidine for procedural sedation during neuraxial anesthesia placement for cesarean delivery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including patient satisfaction and memory preservation
What Are the Treatments Tested in This Trial?
Interventions
- Dexmedetomidine
- Remimazolam
Trial Overview
The study compares two sedative medications—remimazolam and dexmedetomidine—given through an IV during spinal or epidural anesthesia placement in planned C-sections. Participants are randomly assigned to one of the two drugs.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to this arm will receive intravenous remimazolam for procedural sedation prior to and during the placement of neuraxial anesthesia (spinal or epidural) for their scheduled cesarean delivery. Dosing will be titrated by an unblinded anesthesiologist to achieve a light target sedation level.
Participants randomized to this arm will receive intravenous dexmedetomidine for procedural sedation prior to and during the placement of neuraxial anesthesia (spinal or epidural) for their scheduled cesarean delivery. Dosing will be titrated by an unblinded anesthesiologist to achieve a light target sedation level.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Citations
Intraoperative remimazolam-nalbuphine infusion reduces ...
Remimazolam combined with nalbuphine significantly reduces VTR during cesarean delivery, providing effective sedation and analgesia while maintaining ...
Remimazolam in obstetric anaesthesia: a focused review
Remimazolam was associated with deeper sedation, improved maternal comfort, and a lower incidence of newly developed intraoperative nausea and vomiting
Comparison of remimazolam and midazolam ...
In conclusion, compared with midazolam, remimazolam significantly reduced the incidence and severity of newly developed IONV during sedation ...
Effectiveness of Remimazolam on Preventing Adverse ...
Remimazolam significantly reduces nausea and vomiting in cesarean sections, enhancing patient satisfaction (P < 0.05).
Perioperative clinical outcomes of remimazolam in regional ...
Qiao et al. also reported a high overall sedation success rate (98.93%) with remimazolam [19]. These data suggest that remimazolam may provide ...
Remimazolam as a Novel Option for Procedural Sedation - PMC
Clinical studies have demonstrated that remimazolam not only provides faster induction and recovery times but also achieves higher sedation ...
Review of clinical advances in the procedural sedation ...
Results demonstrated a 100% sedation success rate for remimazolam, along with predictable duration of action and high sedation safety. This study suggests that ...
8.
jdc.jefferson.edu
jdc.jefferson.edu/context/anfp/article/1095/viewcontent/Remimazolam_and_Its_Place_in_the_Current_Landscape_of_Procedural_Sedation_and_General__Anesthesia.pdfRemimazolam and Its Place in the Current Landscape of ...
remimazolam was seen to have a quicker onset of sedation, stronger safety profile and shorter neuropsychiatric recovery period
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