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

NCT05736341 | Completed DMC

• 1 other identifier: 4-2022-1528
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Cesarean Section; Spinal Anesthesia

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Remimazolam

EXPERIMENTAL

Patient group who receives remimazolam for sedation after delivery

Drug: Remimazolam besylate

Midazolam

ACTIVE COMPARATOR

Patient group who receives midazolam for sedation after delivery

Drug: Midazolam

Interventions

Remimazolam besylate DRUG

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

Remimazolam

Midazolam DRUG

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

Midazolam

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: As this study evaluates intraoperative nausea and vomiting during Cesarean section, only female participants are eligible to this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (age ≥ 20yrs and ASA Class II or III) who are scheduled for elective Cesarean section

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Seung Hyun Kim

  Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 21, 2023
• Study Start: May 17, 2023
• Primary Completion: May 17, 2023
• Study Completion: January 6, 2024
• Last Updated: February 6, 2024

Record last verified: 2023-06

Locations

KR (1)