Clinical trial NCT05736341: Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
Official title: Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Cesarean Section
Spinal Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: intraoperative nausea and vomiting during sedative period
timeFrame: at 5 minutes after sedative administration
measure: intraoperative nausea and vomiting during sedative period
timeFrame: at 10 minutes after sedative administration
measure: intraoperative nausea and vomiting during sedative period
timeFrame: at 15 minutes after sedative administration
measure: intraoperative nausea and vomiting during sedative period
timeFrame: at 20 minutes after sedative administration
measure: intraoperative nausea and vomiting during sedative period
timeFrame: at 25 minutes after sedative administration
measure: intraoperative nausea and vomiting during sedative period
timeFrame: at 30 minutes after sedative administration
measure: intraoperative nausea and vomiting during sedative period
timeFrame: at 60 minutes after sedative administration
measure: intraoperative nausea and vomiting during sedative period
timeFrame: at the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
name: Seung Hyun Kim
role: PRINCIPAL_INVESTIGATOR
References: