Spinal Marginally Hyperbaric Ropivacaine for Cesarean Delivery

NCT03142880 | Unknown

• 1 other identifier: ZX01
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

marginally hyperbaric; ropivacaine; cesarean

Outcome Measures

Primary Outcomes (1)

• The maximum cephalad sensory block level

  The highest cephalad sensory block level is determined by pinprick along both sides of the midclavicular line.

  During 50 min post spinal injection

Secondary Outcomes (2)

• The incidence of hypotension

  During 50 min post spinal injection

• The change rate of invasive arterial pressure

  During 15 min post spinal injection

Study Arms (2)

commonly hyperbaric ropivacaine group

ACTIVE COMPARATOR

This group will receive spinal anesthesia with commonly hyperbaric ropivacaine solution,which was made by adding 50% glucose to the plain ropivacaine commercially availablethe to make it's density is close to commonly hyperbaric bupivacaine.

Combination Product: hyperbaric ropivacaine

marginally hyperbaric ropivacaine group

EXPERIMENTAL

This group will receive spinal anesthesia with marginally hyperbaric ropivacaine,which was made by adding 5% glucose to the plain ropivacaine commercially availablethe to make it's density is slightly denser than cerebrospinal fluid but much less denser than commonly hyperbaric bupivacaine/ropivacaine.

Combination Product: hyperbaric ropivacaine

Interventions

hyperbaric ropivacaine COMBINATION_PRODUCT

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.

Also known as: commonly or marginally hyperbaric ropivacaine

commonly hyperbaric ropivacaine group; marginally hyperbaric ropivacaine group

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• They had dysfunctional coagulation; had pregnancy-induced hypertension; or had infection around the anesthesia puncture site; or multiple pregnancies, suspected fetal abnormality, and if the gestational age of the infant was less than 36 weeks.

Sponsors & Collaborators

• Qilu Hospital of Shandong University (Qingdao): lead

Related Publications (2)

• Tang WX, Li JJ, Bu HM, Fu ZJ. Spinal anaesthesia with low-dose bupivacaine in marginally hyperbaric solutions for caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):493-8. doi: 10.1097/EJA.0000000000000112.

  PMID: 25032943 BACKGROUND

• Khaw KS, Ngan Kee WD, Wong M, Ng F, Lee A. Spinal ropivacaine for cesarean delivery: a comparison of hyperbaric and plain solutions. Anesth Analg. 2002 Mar;94(3):680-5; table of contents. doi: 10.1097/00000539-200203000-00037.

  PMID: 11867397 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 8, 2017
• Study Start: May 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share