Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia
Crystalloid Versus Crystalloid and Colloid Combination Preload for Prevention of Hypotension in Patients Undergoing Elective Caesarean Section Under Intrathecal Anesthesia
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The aim of this study was to compare between crystalloid versus crystalloid and colloid combination preloads for prevention of hypotension following intrathecal anaesthesia in patients undergoing elective Caesarean section. To examine weather baseline perfusion index could predict the incidence of intrathecal-induced hypotension during Caesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2018
Shorter than P25 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
March 3, 2018
CompletedFirst Posted
Study publicly available on registry
March 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedMarch 15, 2018
March 1, 2018
1 year
March 3, 2018
March 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of hypotension
Decrease in systolic blood pressure more than 20% of base line
1 hour
Secondary Outcomes (3)
Perfusion index
1 hour
Heart rate
1 hour
Urine output
1 hour
Study Arms (2)
Ringer
ACTIVE COMPARATORThis group will receive 1 L of Ringer's solution as a preload
Voluven
ACTIVE COMPARATORThis group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload
Interventions
Eligibility Criteria
You may qualify if:
- Age : 18-40 years
- ASA 1\&2
You may not qualify if:
- Patients with morbid obesity.
- Pre-existing or pregnancy-induced hypertension.
- Known cardiovascular or cerebrovascular disease.
- Abnormal CTG tracing.
- Any other contraindications for intrathecal anaesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Ripolles Melchor J, Espinosa A, Martinez Hurtado E, Casans Frances R, Navarro Perez R, Abad Gurumeta A, Calvo Vecino JM. Colloids versus crystalloids in the prevention of hypotension induced by spinal anesthesia in elective cesarean section. A systematic review and meta-analysis. Minerva Anestesiol. 2015 Sep;81(9):1019-30. Epub 2014 Dec 11.
PMID: 25501602BACKGROUNDNgan Kee WD. Confidential enquiries into maternal deaths: 50 years of closing the loop. Br J Anaesth. 2005 Apr;94(4):413-6. doi: 10.1093/bja/aei069. No abstract available.
PMID: 15758080RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 3, 2018
First Posted
March 15, 2018
Study Start
March 1, 2018
Primary Completion
March 1, 2019
Study Completion
April 1, 2019
Last Updated
March 15, 2018
Record last verified: 2018-03