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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05736341
• Other study ID #: 4-2022-1528
• Status: Completed
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: January 6, 2024

Study information

• Verified date: June 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 6, 2024
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Pregnancy
• Spinal Anesthesia
• Vomiting

Intervention

Drug:
• Remimazolam besylate
After delivery, patients in this group receives 5mg of remimazolam to induce sedation during the remaining procedures of Cesarean section.
• Midazolam
After delivery, patients in this group receives 2mg of midazolam to induce sedation during the remaining procedures of Cesarean section.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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