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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy, Cesarean Section, Spinal Anesthesia

Intervention / Treatment
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* Drug: Remimazolam besylate
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam<br>Patient group who receives remimazolam for sedation after delivery | Drug: Remimazolam besylate<br>* After delivery, patients in this group receives 5mg of remimazolam to induce sedation during the remaining procedures of Cesarean section.<br>|
| Active Comparator: Midazolam<br>Patient group who receives midazolam for sedation after delivery | Drug: Midazolam<br>* After delivery, patients in this group receives 2mg of midazolam to induce sedation during the remaining procedures of Cesarean section.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative nausea and vomiting during sedative period | 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. | at 5 minutes after sedative administration | 
| intraoperative nausea and vomiting during sedative period | 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. | at 10 minutes after sedative administration | 
| intraoperative nausea and vomiting during sedative period | 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. | at 15 minutes after sedative administration | 
| intraoperative nausea and vomiting during sedative period | 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. | at 20 minutes after sedative administration | 
| intraoperative nausea and vomiting during sedative period | 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. | at 25 minutes after sedative administration | 
| intraoperative nausea and vomiting during sedative period | 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. | at 30 minutes after sedative administration | 
| intraoperative nausea and vomiting during sedative period | 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. | at 60 minutes after sedative administration | 
| intraoperative nausea and vomiting during sedative period | 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. | at the end of surgery |