Dose-response Study of Spinally Administered Ropivacaine for Caesarean Section in Tall Parturients
Launched by PARASKEVI MATSOTA · May 2, 2019
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
The primary objective of this study is to determine the dose-response relationship of subarachnoid (spinal) administered ropivacaine to healthy tall parturients scheduled to undergo elective caesarean section under combined subarachnoid / epidural anaesthesia (CSEA) with co-administration of a fixed dose of fentanyl. The dose-response relationship will be described by determining ED50 (Effective Dose 50) and MLAD (Minimum Local Anaesthetic Dose).
The height threshold of the participants is based on the study "National Anthropometric Research: Effectiveness of Ergonomic Measurements and App...
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • ASA status I - II (ASA; American Society of Anesthesiologists)
- • height: 167 to 184 cm
- • age: 20 to 40 years old
- • normal single pregnancy
- • full term pregnancy (\> 37 weeks)
- • elective caesarean section.
- Exclusion Criteria:
- • refusal of the parturient, inability to communicate
- • obesity (BMI\> 35 Kg/m2)
- • baseline maternal heart rate less than 60 or above 130 bpm
- • high risk pregnancy (gestational hypertension, preeclampsia / eclampsia, gestational diabetes, multiple pregnancies)
- • known or suspected foetal pathology (intrauterine growth retardation, poly- or oligohydramnios)
- • history of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, psychiatric or metabolic disease
- • active labour
- • history of allergy in amidic anaesthetics or any of the drugs used in the trial
- • contraindications for regional technique such as coagulation disorders, inflammation of the lumbar region, systemic sepsis
- • dural puncture.
About Paraskevi Matsota
Paraskevi Matsota is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative study designs and rigorous methodologies. With a focus on ethical practices and regulatory compliance, Paraskevi Matsota leads a diverse portfolio of clinical trials across various therapeutic areas. The organization collaborates with healthcare professionals, regulatory authorities, and research institutions to ensure the integrity of its studies and the safety of participants. By fostering a culture of scientific excellence and transparency, Paraskevi Matsota aims to contribute meaningful insights to the medical community and enhance the development of new therapies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Athens, Attiki, Greece
Patients applied
Trial Officials
Paraskevi Matsota, MD, PhD
Principal Investigator
Associate Professor of Anaesthesiology, Second University Clinic of Anaesthesiology, Faculty of Medicine, University of Athens
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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