Clinical Trials Directory

Trials / Completed

CompletedNCT05736341

Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Yonsei University · Academic / Other
Sex
Female
Age
20 Years
Healthy volunteers
Not accepted

Summary

Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, high-level blockage or hypotension induced by this technique may induce intraoperative nausea and vomiting (IONV), which is associated with patient discomfort and protrusion of abdominal viscera which may adversely affect patient safety. To prevent IONV, midazolam is frequently administered after delivery, but risk of hypotension and prolonged sedation due to its active metabolite also increases. On the other hand, remimazolam is known to have relatively shorter half-life and less likely induce hypotension when compared to midazolam, yet its effect on IONV has not been thoroughly evaluated. Hence, this study aimed to compare the effects of remimazolam and midazolam in preventing IONV in patients scheduled for elective Cesarean section.

Conditions

Interventions

TypeNameDescription
DRUGRemimazolam besylateAfter delivery, patients in this group receives 5mg of remimazolam to induce sedation during the remaining procedures of Cesarean section.
DRUGMidazolamAfter delivery, patients in this group receives 2mg of midazolam to induce sedation during the remaining procedures of Cesarean section.

Timeline

Start date
2023-05-17
Primary completion
2023-05-17
Completion
2024-01-06
First posted
2023-02-21
Last updated
2024-02-06

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05736341. Inclusion in this directory is not an endorsement.

Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under (NCT05736341) · Clinical Trials Directory