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Effectiveness of remimazolam on preventing adverse reactions caused by carboprost tromethamine during cesarean section

Effectiveness of remimazolam on preventing adverse reactions caused by carboprost tromethamine during cesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47530284
Enrollment
100
Registered
2023-11-16
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean section women at risk of postpartum hemorrhage Pregnancy and Childbirth

Interventions

The participants will be assigned via random number table method to either a study group or a control group. All parturients will receive combined spinal and epidural anesthesia (CSEA) during cesarean

Sponsors

Baotou Science and Technology Bureau (????????)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Aged 24-45 years old 2. Indication for cesarean section, planned elective cesarean section 3. American Society of Anesthesiologists (ASA) grade I-II 4. Presence of risk factors for uterine atony, such as scar pregnancy, multiple pregnancies, macrosomia, psychological stress, and making natural labor inappropriate.

Exclusion criteria

Exclusion criteria: 1. Genital tract anomalies 2. Coagulation disorders 3. Allergy to drugs and related solvents intended for use during surgery 4. Pre-existing conditions such as severe gastric ulcers, duodenal ulcers, reflux esophagitis, or other conditions that could lead to symptoms such as nausea, vomiting, chest discomfort, palpitations, abdominal pain, or diarrhea

Design outcomes

Primary

MeasureTime frame
1. Postpartum bleeding volume measured using patient records. The bleeding volume of parturients at 2 hours and 24 hours postpartum and the time to cessation of bleeding are recorded and compared between the two groups. 2. Sedation effect measured using the Ramsay Sedation Scale (RSS) to assess intraoperative sedation levels. The scale is as follows: 1 point: Anxious, restless; 2 points: Awake, calm, cooperative; 3 points: Drowsy, responsive to commands; 4 points: Light sleep, easily awakened; 5 points: Asleep, sluggish response to stimulation; 6 points: Deep sleep, no response to stimulation. Sedation levels were categorized as follows: 1 point indicated inadequate sedation, 2-4 points indicated moderate sedation, and 5-6 points indicated excessive sedation. Sedation efficacy (%) = (Sum of cases with 3-4 points) / Total cases × 100%. 3. Adverse reactions: Adverse reactions (nausea and vomiting, stomach pain, chest pain, palpitations, elevated blood pressure, headache) occurring between admission and the end of surgery. The severity of nausea and vomiting is graded as follows: Level 0: No nausea or vomiting; Grade 1: nausea but no vomiting; Grade 2: Nausea or vomiting 1-2 times within an hour; Level 3: Nausea or vomiting three or more times within an hour

Secondary

MeasureTime frame
Satisfaction score measured using a patient questionnaire of the satisfaction of the whole treatment process, which is divided into very satisfied, satisfied and dissatisfied, before discharge

Countries

China

Contacts

Public ContactJianjun Fan
fanjianjun2065@163.com+86-0472-2166970

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026