Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Remimazolam Patient group who receives remimazolam for sedation after delivery |
Drug: Remimazolam besylate
After delivery, patients in this group receives 5mg of remimazolam to induce sedation during the remaining procedures of Cesarean section.
|
| Active Comparator: Midazolam Patient group who receives midazolam for sedation after delivery |
Drug: Midazolam
After delivery, patients in this group receives 2mg of midazolam to induce sedation during the remaining procedures of Cesarean section.
|
Outcome Measures
Primary Outcome Measures
- intraoperative nausea and vomiting during sedative period [at 5 minutes after sedative administration]
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.
- intraoperative nausea and vomiting during sedative period [at 10 minutes after sedative administration]
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.
- intraoperative nausea and vomiting during sedative period [at 15 minutes after sedative administration]
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.
- intraoperative nausea and vomiting during sedative period [at 20 minutes after sedative administration]
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.
- intraoperative nausea and vomiting during sedative period [at 25 minutes after sedative administration]
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.
- intraoperative nausea and vomiting during sedative period [at 30 minutes after sedative administration]
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.
- intraoperative nausea and vomiting during sedative period [at 60 minutes after sedative administration]
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.
- intraoperative nausea and vomiting during sedative period [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yonsei University Health System, Severance Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Yonsei University
Investigators
- Principal Investigator: Seung Hyun Kim, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4-2022-1528