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Completed

NCT Number: NCT05736341

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

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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Key information

Conditions

Pregnancy Cesarean Section Spinal Anesthesia

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam besylate

Drug

After delivery, patients in this group receives 5mg of remimazolam to induce sedation during the remaining procedures of Cesarean section.

midazolam

Drug

After delivery, patients in this group receives 2mg of midazolam to induce sedation during the remaining procedures of Cesarean section.

Primary outcomes

  1. intraoperative nausea and vomiting during sedative period

    Time frame: 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.

  2. intraoperative nausea and vomiting during sedative period

    Time frame: 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.

  3. intraoperative nausea and vomiting during sedative period

    Time frame: 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.

  4. intraoperative nausea and vomiting during sedative period

    Time frame: 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.

  5. intraoperative nausea and vomiting during sedative period

    Time frame: 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.

  6. intraoperative nausea and vomiting during sedative period

    Time frame: 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.

  7. intraoperative nausea and vomiting during sedative period

    Time frame: 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.

  8. intraoperative nausea and vomiting during sedative period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 21, 2023
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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