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OpenTrials
Completed

NCT Number: NCT02802683

Hemodynamic Impact of Hyperbaric Versus Isobaric for Spinal Anesthesia During Cesarean Delivery

The purpose of this study is to compare the frequency of hypotension between hyperbaric anesthetics and isobaric anesthetics during cesarean section and determine whether continuous infusion of phenylephrine is effective in mothers who received hyperbaric anesthetics.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant woman scheduled for elective cesarean delivery under spinal anesthesia

Exclusion criteria

  • patients who refuse involved
  • patients who have pre-eclampsia
  • patients who have heart disease
  • patients who fetal distress is suspicious

Treatment and study plan

Bupivacaine

Drug

spinal anesthesia with hyperbaric bupivacaine

Other names: Heavy bupivacaine

Levobupivacaine

Drug

spinal anesthesia with isobaric levobupivacaine

Other names: chirocaine

Phenylephrine

Drug

continous infusion of phenylephrine

normal saline

Drug

continous infusion of normal saline

Primary outcomes

  1. Number of hypotension events with treatment related

    Time frame: during 30min after spinal anesthesia

    blood pressure was obtained every 1min. A 20% decrease or more decrease in SAP compared to baseline was considered as hypotension. Hypotensive events during first 30 min was recorded as primary outcome.

Secondary outcomes

  1. total dose of phenylephrine

    Time frame: during the surgery

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2016
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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