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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Experimental | Patient group who receives remimazolam for sedation after delivery |
|
| Midazolam | Active Comparator | Patient group who receives midazolam for sedation after delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam besylate | Drug | After delivery, patients in this group receives 5mg of remimazolam to induce sedation during the remaining procedures of Cesarean section. |
|
| 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. |
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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
As this study evaluates intraoperative nausea and vomiting during Cesarean section, only female participants are eligible to this study.
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| Name | Affiliation | Role |
|---|---|---|
| Seung Hyun Kim | Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
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| Midazolam | Drug | After delivery, patients in this group receives 2mg of midazolam to induce sedation during the remaining procedures of Cesarean section. |
|
| 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 |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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