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Spinal Marginally Hyperbaric Ropivacaine for Cesarean Delivery

NCT03142880 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-05-09

No results posted yet for this study

Summary

BACKGROUND: One previous study has confirmed that the marginally hyperbaric solutions of bupivacaine can maintain good quality of anesthesia and get a more steadily hemodynamic status than commonly hyperbaric solutions, some authors confirmed the plain ropivacaine for cesarean section have a higher failure rate and commonly hyperbaric solutions of ropivacaine have a higher incidence of side reaction. It is unclear what the efficacy of spinal marginally hyperbaric ropivacaine for elective cesarean delivery.We hypothesized that the marginally hyperbaric ropivacaine will get a similar efficacy to commonly hyperbaric solutions but a more steadily hemodynamic status.

OBJECTIVE In this prospective, randomized, double-blinded study, Investigator will compare the clinical efficacy and adverse effect of spinal anesthesia with commonly hyperbaric and marginally hyperbaric ropivacaine for elective cesarean delivery.

Main outcome measures: The maximum cephalad sensory block level; the change of continuous cerebral oxygen desaturation (ScO2) over time; the incidence of hypotension and nausea and vomiting; the change of invasive arterial pressure; the consumption of ephedrine; the incidence of shivering; the onset time to T8 dermatome; the quality of anesthesia (efficacy of motor block and sensory block)

Conditions

  • Anesthesia, Spinal

Interventions

COMBINATION_PRODUCT

hyperbaric ropivacaine

We change the density of ropivacaine solution to make it into an marginally hyperbaric state or into an commonly hyperbaric state.and we hypothesized that the marginally hyperbaric ropivacaine will get a similar efficacy to commonly hyperbaric solutions but a more steadily hemodynamic status.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University (Qingdao)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2017-09-30
Completion
2017-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03142880 on ClinicalTrials.gov