MidazolamNCT07021521
Midazolam Efficacy/Safety in Pre-Eclamptic C-Section Sedation
A study testing 0.01 mg/kg Midazolam Group, 0.02 mg/kg Midazolam Group and 0.03 mg/kg Midazolam Group in people with Midazolam and Pre-eclampsia, run by Zhuji People's Hospital of Zhejiang Province at 1 site in China.
Trial summary
This study will compare four different doses of midazolam (0 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.03 mg/kg) administered intravenously to women with pre-eclampsia undergoing cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Midazolam, Pre-eclampsia, Cesarean Section
- What is being tested?
- 0.01 mg/kg Midazolam Group, 0.02 mg/kg Midazolam Group and 0.03 mg/kg Midazolam Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2021to 26 Apr 2023
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women diagnosed with pre-eclampsia [6] requiring emergency or planned cesarean section
- Age 18-40 years
- No history of midazolam or related drug allergies
- Able to comply with study protocol (no communication barriers)
- No history of mental illness or substance abuse
- Provided informed consent (patient or legal representative)
Who cannot join
- Concurrent use of drugs interacting with midazolam
- Severe organ dysfunction (heart, liver, or kidneys)
- Participation in other clinical trials potentially affecting results
- Coagulation disorders or hematological conditions
- Inability to adhere to study protocol
- Severe intraoperative complications (e.g., hemorrhage) compromising data reliability
- Additional sedative/analgesic use within 24 hours post-cesarean
Trial locations and contacts
1 site in 1 country.
China1 site
Zhuji People's Hospital of Zhejiang Province
Shaoxing, Zhejiang, 311800
About this study
Official title: Efficacy and Safety of Different Doses of Midazolam for 24-Hour Continuous Sedation in Pre-Eclamptic Women Undergoing Cesarean Section
This study will compare four different doses of midazolam (0 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.03 mg/kg) administered intravenously to women with pre-eclampsia undergoing cesarean section. The study aims to evaluate how these different doses affect:
The mother's vital signs (oxygen levels, blood pressure, heart rate) The mother's anxiety levels The baby's condition after birth Any potential side effects Participants will be randomly assigned to one of the four dose groups. Medical staff will monitor both mother and baby for 24 hours after the medication is given.
Read the detailed description
This study aimed to investigate the efficacy and safety of different doses of midazolam for 24-hour continuous sedation in pre-eclamptic women undergoing cesarean section. A total of 124 pre-eclamptic women admitted from April 2021 to April 2023, scheduled for cesarean section at our hospital, were randomly assigned to Group A, Group B, Group C, and Group D, with 31 women in each group. Midazolam was administered intravenously at doses of 0 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.03 mg/kg, respectively. We compared the oxygen saturation (SPO2), mean arterial pressure (MAP), and heart rate (HR) levels before and 30 minutes after drug administration in all four groups. Visual anxiety scores, fetal Kreb's scores, and sedation efficacy indicators (fentanyl dosage, onset time of sedation, mechanical ventilation time) were assessed in the women at 24 hours before and after the surgery. Adverse reactions were also recorded.
- Conditions
- Midazolam, Pre-eclampsia, Cesarean Section, Efficacy, Safety
- Being tested
- 0 mg/kg Midazolam (Control Group), 0.01 mg/kg Midazolam Group, 0.02 mg/kg Midazolam Group, 0.03 mg/kg Midazolam Group
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 mg/kg Midazolam (Control Group)Drug
- Intravenous administration of volume-matched normal saline (0 mg/kg midazolam equivalent)
- Administered as single bolus prior to epidural anesthesia
- Served as active comparator for dose-response evaluation
0.01 mg/kg Midazolam GroupDrug
- Intravenous midazolam at 0.01 mg/kg (diluted in normal saline)
- Administered as single bolus over 2 minutes
- Manufacturer: Jiangsu Enhua Pharmaceutical Co., Ltd. (Approval H19990027)
0.02 mg/kg Midazolam GroupDrug
- Intravenous midazolam at 0.02 mg/kg
- Identical administration protocol as 0.01 mg/kg group
- Primary focus: Intermediate dose efficacy/safety assessment
0.03 mg/kg Midazolam GroupDrug
- Intravenous midazolam at 0.03 mg/kg (maximum tested dose)
- Special hemodynamic monitoring due to dose-dependent MAP effects
- Primary focus: Optimal dose determination
| Study group | Role | What they receive |
|---|---|---|
| 0 mg/kg Midazolam (Control Group) | Placebo comparator | * Received intravenous saline placebo (volume-matched to active doses)
* Standard epidural anesthesia with 1.6% lidocaine (15-18 mL to T6 level)
* Hemodynamic monitoring per protocol Receives: Drug: 0 mg/kg Midazolam (Control Group) |
| 0.01 mg/kg Midazolam Group | Experimental | * Intravenous midazolam at 0.01 mg/kg (Jiangsu Enhua Pharmaceutical Co., Ltd.)
* Standard epidural anesthesia as in Arm 1
* Continuous sedation monitoring for 24 hours post-dose Receives: Drug: 0.01 mg/kg Midazolam Group |
| 0.02 mg/kg Midazolam Group | Experimental | * Intravenous midazolam at 0.02 mg/kg
* Identical anesthesia and monitoring protocols as other arms
* Primary focus: Dose-response evaluation for sedation efficacy Receives: Drug: 0.02 mg/kg Midazolam Group |
| 0.03 mg/kg Midazolam Group | Experimental | * Intravenous midazolam at 0.03 mg/kg (highest tested dose)
* Enhanced monitoring for hemodynamic effects (MAP, HR, SpO₂)
* Primary focus: Optimal dose determination balancing efficacy/safety Receives: Drug: 0.03 mg/kg Midazolam Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal anxiety reduction using Visual Analog Anxiety Rating Scale (VAS-A)
Comparison of anxiety scores using the Visual Analog Anxiety Rating Scale (VAS-A; range 0-10 cm, where 0 = "no anxiety" and 10 = "worst possible anxiety") at 24 hours post-cesarean section among groups receiving different midazolam doses (0, 0.01, 0.02, or 0.03 mg/kg). Higher scores indicate worse anxiety.
Measured: 24 hours after cesarean section.
Secondary outcomes (4)
Fentanyl consumption during sedation
Total fentanyl dosage (μg) required for adequate sedation in each group.
Measured: Intraoperative period through 24 hours post-surgery
Sedation onset time
Time (minutes) from midazolam administration to achieving target sedation level (Ramsay Sedation Scale ≥4).
Measured: 0-60 minutes post-dose
Mechanical ventilation duration
Total hours of required mechanical ventilation post-cesarean.
Measured: From surgery completion until extubation (up to 24 hours)
Hemodynamic stability (MAP)
Mean arterial pressure (mmHg) changes from baseline at 30 minutes post-dose.
Measured: 30 minutes post-midazolam administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start5 Apr 2021
- Primary completion3 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MidazolamStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuji People's Hospital of Zhejiang Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongmei Xuan, Zhuji People's Hospital of Zhejiang Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021521
- Sponsor's protocol ID
- No. 2025-0224
- Status last verified
- Apr 2021
- First submitted
- 4 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Doses of Midazolam for 24-Hour Continuous Sedation in Pre-Eclamptic Women Undergoing Cesarean Section
- ClinicalTrials.gov ID
- NCT07021521
- Acronym / sponsor ID
- No. 2025-0224
- Conditions
- Midazolam, Pre-eclampsia, Cesarean Section, Efficacy, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Zhuji People's Hospital of Zhejiang ProvinceUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 15 Jun 2025 (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.
This study will compare four different doses of midazolam (0 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.03 mg/kg) administered intravenously to women with pre-eclampsia undergoing cesarean section. The study aims to evaluate how these different doses affect:
The mother's vital signs (oxygen levels, blood pressure, heart rate) The mother's anxiety levels The baby's condition after birth Any potential side effects Participants will be randomly assigned to one of the four dose groups. Medical staff will monitor both mother and baby for 24 hours after the medication is given.
Detailed description
This study aimed to investigate the efficacy and safety of different doses of midazolam for 24-hour continuous sedation in pre-eclamptic women undergoing cesarean section. A total of 124 pre-eclamptic women admitted from April 2021 to April 2023, scheduled for cesarean section at our hospital, were randomly assigned to Group A, Group B, Group C, and Group D, with 31 women in each group. Midazolam was administered intravenously at doses of 0 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.03 mg/kg, respectively. We compared the oxygen saturation (SPO2), mean arterial pressure (MAP), and heart rate (HR) levels before and 30 minutes after drug administration in all four groups. Visual anxiety scores, fetal Kreb's scores, and sedation efficacy indicators (fentanyl dosage, onset time of sedation, mechanical ventilation time) were assessed in the women at 24 hours before and after the surgery. Adverse reactions were also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 mg/kg Midazolam (Control Group) | Placebo comparator | Drug: 0 mg/kg Midazolam (Control Group)* Received intravenous saline placebo (volume-matched to active doses) * Standard epidural anesthesia with 1.6% lidocaine (15-18 mL to T6 level) * Hemodynamic monitoring per protocol |
| 0.01 mg/kg Midazolam Group | Experimental | Drug: 0.01 mg/kg Midazolam Group* Intravenous midazolam at 0.01 mg/kg (Jiangsu Enhua Pharmaceutical Co., Ltd.) * Standard epidural anesthesia as in Arm 1 * Continuous sedation monitoring for 24 hours post-dose |
| 0.02 mg/kg Midazolam Group | Experimental | Drug: 0.02 mg/kg Midazolam Group* Intravenous midazolam at 0.02 mg/kg * Identical anesthesia and monitoring protocols as other arms * Primary focus: Dose-response evaluation for sedation efficacy |
| 0.03 mg/kg Midazolam Group | Experimental | Drug: 0.03 mg/kg Midazolam Group* Intravenous midazolam at 0.03 mg/kg (highest tested dose) * Enhanced monitoring for hemodynamic effects (MAP, HR, SpO₂) * Primary focus: Optimal dose determination balancing efficacy/safety |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women diagnosed with pre-eclampsia [6] requiring emergency or planned cesarean section
- Age 18-40 years
- No history of midazolam or related drug allergies
- Able to comply with study protocol (no communication barriers)
- No history of mental illness or substance abuse
Key exclusion criteria (7 listed)
- Concurrent use of drugs interacting with midazolam
- Severe organ dysfunction (heart, liver, or kidneys)
- Participation in other clinical trials potentially affecting results
- Coagulation disorders or hematological conditions
- Inability to adhere to study protocol
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 |
|---|---|---|
| 0 mg/kg Midazolam (Control Group)* Intravenous administration of volume-matched normal saline (0 mg/kg midazolam equivalent) * Administered as single bolus prior to epidural anesthesia * Served as active comparator for dose-response evaluation | Drug | 0 mg/kg Midazolam (Control Group) |
| 0.01 mg/kg Midazolam Group* Intravenous midazolam at 0.01 mg/kg (diluted in normal saline) * Administered as single bolus over 2 minutes * Manufacturer: Jiangsu Enhua Pharmaceutical Co., Ltd. (Approval H19990027) | Drug | 0.01 mg/kg Midazolam Group |
| 0.02 mg/kg Midazolam Group* Intravenous midazolam at 0.02 mg/kg * Identical administration protocol as 0.01 mg/kg group * Primary focus: Intermediate dose efficacy/safety assessment | Drug | 0.02 mg/kg Midazolam Group |
| 0.03 mg/kg Midazolam Group* Intravenous midazolam at 0.03 mg/kg (maximum tested dose) * Special hemodynamic monitoring due to dose-dependent MAP effects * Primary focus: Optimal dose determination | Drug | 0.03 mg/kg Midazolam Group |
Primary outcome
Maternal anxiety reduction using Visual Analog Anxiety Rating Scale (VAS-A)
Time frame: 24 hours after cesarean section.
Comparison of anxiety scores using the Visual Analog Anxiety Rating Scale (VAS-A; range 0-10 cm, where 0 = "no anxiety" and 10 = "worst possible anxiety") at 24 hours post-cesarean section among groups receiving different midazolam doses (0, 0.01, 0.02, or 0.03 mg/kg). Higher scores indicate worse anxiety.
4 secondary outcomes
Fentanyl consumption during sedation
Time frame: Intraoperative period through 24 hours post-surgery
Sedation onset time
Time frame: 0-60 minutes post-dose
Mechanical ventilation duration
Time frame: From surgery completion until extubation (up to 24 hours)
Hemodynamic stability (MAP)
Time frame: 30 minutes post-midazolam administration
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 15 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.01 mg/kg Midazolam Group, 0.02 mg/kg Midazolam Group and 0.03 mg/kg Midazolam Group in people with Midazolam and Pre-eclampsia, run by Zhuji People's Hospital of Zhejiang Province at 1 site in China.
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 6 inclusion and 7 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 15 Jun 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
Maternal anxiety reduction using Visual Analog Anxiety Rating Scale (VAS-A) (time frame: 24 hours after cesarean section.). 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 15 Jun 2025.