PregnancyNCT05736341
Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
A study testing Remimazolam besylate and Midazolam in people with Pregnancy and Cesarean Section, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Pregnancy, Cesarean Section, Spinal Anesthesia
- What is being tested?
- Remimazolam besylate and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 May 2023to 6 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (age ≥ 20yrs and ASA Class II or III) who are scheduled for elective Cesarean section
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
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
- Being tested
- Remimazolam besylate, Midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam besylateDrug
After delivery, patients in this group receives 5mg of remimazolam to induce sedation during the remaining procedures of Cesarean section.
MidazolamDrug
After delivery, patients in this group receives 2mg of midazolam to induce sedation during the remaining procedures of Cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam | Experimental | Patient group who receives remimazolam for sedation after delivery Receives: Drug: Remimazolam besylate |
| Midazolam | Active comparator | Patient group who receives midazolam for sedation after delivery Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start17 May 2023
- Primary completion17 May 2023
- Study completion6 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seung Hyun Kim, Principal investigator, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736341
- Sponsor's protocol ID
- 4-2022-1528
- Status last verified
- Jun 2023
- First submitted
- 1 Feb 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Remimazolam and Midazolam for Preventing Intraoperative Nausea and Vomiting During Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT05736341
- Acronym / sponsor ID
- 4-2022-1528
- Conditions
- Pregnancy, Cesarean Section, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 6 Jan 2024 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remimazolam | Experimental | Drug: Remimazolam besylatePatient group who receives remimazolam for sedation after delivery |
| Midazolam | Active comparator | Drug: MidazolamPatient group who receives midazolam for sedation after delivery |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (age ≥ 20yrs and ASA Class II or III) who are scheduled for elective Cesarean section
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remimazolam besylateAfter delivery, patients in this group receives 5mg of remimazolam to induce sedation during the remaining procedures of Cesarean section. | Drug | Remimazolam |
| MidazolamAfter delivery, patients in this group receives 2mg of midazolam to induce sedation during the remaining procedures of Cesarean section. | Drug | Midazolam |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung Hyun Kim principal investigator
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remimazolam besylate and Midazolam in people with Pregnancy and Cesarean Section, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative nausea and vomiting during sedative period (time frame: at 5 minutes after sedative administration). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.