Colloid Preload Versus Crystalloid Co-load in Cesarean Section Under Spinal Anesthesia

NCT03107598 | Terminated

• 1 other identifier: LCS
• Study Type: interventional
• Target: 127
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison between colloid preload and crystalloid co-load in cesarean section under spinal anesthesia.

1. 1.The primary outcome was the incidence of hypotension
2. 2.Secondary outcomes included the incidence of severe hypotension, total ephedrine dose, nausea and vomiting and neonatal outcome assessed by Apgar scores and umbilical artery blood gas analysis

Conditions

Hypotension

Keywords

spinal anesthesia; neonatal outcome; Caesarean Section

Outcome Measures

Primary Outcomes (1)

• The primary outcome was the incidence of hypotension

  hypotension defined by decreasing of arterial blood pressure under 20% of base line

  2 hours

Secondary Outcomes (4)

• incidence of severe hypotension

  2 hours

• total ephedrine dose

  2 hours

• nausea and vomiting

  2 hours

• neonatal outcome

  2 hours

Study Arms (2)

colloid preload

EXPERIMENTAL

Group CoP: group with colloid preload The preload group received rapid infusion of 15ml/kg of 6% hydroxyethyl starch (6% HES) administered by gravity at a wide-open rate over a period of 15-30min before induction of spinal anesthesia.

Drug: colloid preload

crystalloid coload

PLACEBO COMPARATOR

Group CrC: group with crystalloid coload The coload group received a sodium chloride 0.9% perfusion as rapidly as possible starting at the time of intrathecal injection for spinal anesthesia.

Drug: colloid preload

Interventions

colloid preload DRUG

coparaison between colloid and crystalloide loading in spinal anesthesia for cesarean section

Also known as: crystalloid coload

colloid preload; crystalloid coload

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 40 years' old
• American Society of Anesthesiologists physical status I or II (ASA)
• Full-term singleton pregnancy
• scheduled for elective cesarean section under spinal anesthesia

You may not qualify if:

• cardiovascular, cerebrovascular or renal disease
• multiple gestations
• polyhydramnios or known fetal abnormalities
• allergy to local anesthetics or opioids
• emergency Cesarean section or parturient that have failed vaginal delivery with epidural analgesia
• contraindications for performing spinal anesthesia

Sponsors & Collaborators

• University Hospital, Mahdia: lead

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of anesthesia department clinical professor

Study Record Dates

• First Submitted: December 30, 2016
• First Posted: April 11, 2017
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 11, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share