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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-17

Study Completion Date

2024-01-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients

NCT04466046

Postoperative Nausea and Vomiting

COMPLETED

Midazolam Versus Dexamethasone-ondansetron in Preventing Postoperative Nausea-vomiting for Laparoscopic Surgeries

NCT03603119

Postoperative Nausea and Vomiting

COMPLETED NA

Effects of Remimazolam on Quality of Recovery After Ambulatory Surgery

NCT05320016

Day Surgery Patient Outcome Assessment Quality of Recovery +1 more

COMPLETED

Remimazolam and Postoperative Nausea and Vomiting in High-risk Patients

NCT04861337

Postoperative Nausea and Vomiting Benzodiazepine High-risk Patients

COMPLETED PHASE4

Effect of Remimazolam on Postoperative Nausea and Vomiting

NCT05439057

Postoperative Nausea and Vomiting

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Cesarean Section Spinal Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Remimazolam

Patient group who receives remimazolam for sedation after delivery

Group Type EXPERIMENTAL

Remimazolam besylate

Intervention Type DRUG

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

Midazolam

Patient group who receives midazolam for sedation after delivery

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remimazolam besylate

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

Intervention Type DRUG

Midazolam

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No