Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section

Hypotension Clinical Trial

Official title:

Cardiac Output Changes During Hyperbaric and Isobaric Bupivacaine in Patients Undergoing Cesarean Section: An Randomization Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737813
• Other study ID #: Marcaine
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2016
• Last updated: July 28, 2017
• Start date: March 29, 2016
• Est. completion date: November 15, 2016

Study information

• Verified date: July 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spinal block leads to the reduction of systemic vascular resistance (SVR) which may effect the cardiac output. Ngan Kee et al. has showed that spina block with 0.5% hyperbaric bupivacaine for Cesarean section combined with intravenous infusion norepinephrine had higher cardiac output than those who received phenylephrine

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: November 15, 2016
• Est. primary completion date: November 11, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiology classification I - II

• Elective or urgency Cesarean section with spinal block e.g. cephalopelvic disproportion, premature rupture of membrane

• Singleton pregnancy

• Body mass index < 40 kg/m2

Exclusion Criteria:

• Pregnancy <35 weeks gestational age

• Hypertensive disease e.g. gestational hypertension, chronic hypertension, preeclampsia

• History of allergy to the study drugs

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Cardiac Output
• Hypotension

Intervention

Drug:
• Isobaric marcaine
Isobaric marcaine 2.2 mL for spinal block
• Hyperbaric marcaine
Hyperbaric marcaine 2.2 mL for spinal block

Locations

Country	Name	City	State
Thailand	Department of Anesthesiology, Faculty of Medicine, Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of cardiac output (L/min) after spinal block	The investigators will measure cardiac output using non-invasive methods (USCOM) before spinal block and 5 minutes after spinal block.	5 minutes after spinal block
Secondary	Total dose of vasopressor	The investigators will record the total dose that treat hypotension during preoperative period	2 hours
Secondary	Number of patients who experience systolic blood pressure < 25% of preoperative measurement	The investigators will monitor blood pressure at interval; before spinal block, then after spinal block every 1 minute for 10 for 10 times, every 2 minute for 5 times, every 3 minutes until delivery then every 5 minutes til the end of surgery. If the patient's systolic blood pressure is declined, vasopressor will be given.	2 hours