Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
Overview
- Phase
- Not Applicable
- Intervention
- Remimazolam besylate
- Conditions
- Pregnancy
- Sponsor
- Yonsei University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- intraoperative nausea and vomiting during sedative period
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients (age ≥ 20yrs and ASA Class II or III) who are scheduled for elective Cesarean section
Exclusion Criteria
- •Emergency surgery Patients who are diagnosed preeclampsia or eclampsia, BMI ≥ 40kg/m2, IUP \< 36 weeks Patients with contraindications to spinal anesthesia Patients who do not want sedation during the procedure
Arms & Interventions
Remimazolam
Patient group who receives remimazolam for sedation after delivery
Intervention: Remimazolam besylate
Midazolam
Patient group who receives midazolam for sedation after delivery
Intervention: Midazolam
Outcomes
Primary Outcomes
intraoperative nausea and vomiting during sedative period
Time Frame: at the end of surgery
Incidence of intraoperative nausea, retching, and vomiting will be evaluated 5, 10, 15, 20, 25, 30, and 60 minutes after sedative administration, and at the end of surgery.