Clinical Trials Logo
  1. Home
  2. Hypotension
  3. NCT02802683
  4. Details
NCT02802683 Clinical Trial

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

Hypotension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02802683
Other study ID # JHBahk_C/S
Secondary ID
Status Completed
Phase Phase 4
First received May 4, 2016
Last updated July 4, 2016
Start date September 2015
Est. completion date June 2016

Study information
Verified date July 2016
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date June 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Bupivacaine
spinal anesthesia with hyperbaric bupivacaine
• Levobupivacaine
spinal anesthesia with isobaric levobupivacaine
• Phenylephrine
continous infusion of phenylephrine
• normal saline
continous infusion of normal saline

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of hypotension events with treatment related 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. during 30min after spinal anesthesia Yes
Secondary total dose of phenylephrine during the surgery Yes
See also
  Status Clinical Trial Phase
Completed NCT04062994 - A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
Active, not recruiting NCT02016599 - Effects of Transitional Circulation in ELBW Infants
Recruiting NCT05836610 - Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates Phase 4
Completed NCT02907931 - Carotid Doppler Ultrasound for the Measurement of Intravascular Volume Status N/A
Completed NCT03215797 - Phenylephrine or Norepinephrine for a Better Hemodynamic Stability Phase 3
Suspended NCT02315937 - Hemodynamic Assessment During Spinal Anesthesia Using Transthoracic Echocardiography' N/A
Recruiting NCT02532270 - Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring N/A
Completed NCT02437799 - Dicrotic Notch and Hypotension at Caesarean Under Spinal Anaesthesia N/A
Completed NCT02146898 - The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery N/A
Completed NCT01930227 - Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hypotension After Spinal Anesthesia in Parturients N/A
Not yet recruiting NCT01941472 - Transcutaneous pO2, Transcutaneous pCO2 and Central Venous pO2 Variations to Predict Fluid Responsiveness N/A
Recruiting NCT01434251 - Treatment of Hypotension of Prematurity (TOHOP) N/A
Completed NCT01592669 - Passive Leg Raising Attenuates and Delays Tourniquet Deflation-induced Hypotension and Tachycardia N/A
Withdrawn NCT01183741 - Accuracy of Non-Invasive Blood Pressure Measurement in Adults Phase 3
Completed NCT00991627 - Different Approaches to Maternal Hypotension During Cesarean Section Phase 4
Withdrawn NCT00750516 - Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Completed NCT00115726 - Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure Phase 4
Recruiting NCT05513066 - Management Arterial Hypotension During Planned Caesarean Section, Intravenous Ephedrine/Phenylephrine Mixture Versus Intravenous Baby Noradrenaline
Completed NCT04089644 - Manual vs Closed-loop Control of Mean Arterial Pressure N/A
Active, not recruiting NCT05250960 - Pre-epidural SCDs to Prevent Hypotension During Labor N/A