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

Yonsei University

Status: Completed

Conditions: Cesarean Section; Spinal Anesthesia; Pregnancy

Treatments: Drug: Midazolam; Drug: Remimazolam besylate

Study type: Interventional

Funder types: Other

Identifiers

NCT05736341

4-2022-1528

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Remimazolam

Experimental group

Description:

Patient group who receives remimazolam for sedation after delivery

Treatment:

Drug: Remimazolam besylate

Midazolam

Active Comparator group

Description:

Patient group who receives midazolam for sedation after delivery

Treatment:

Drug: Midazolam