Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia
Primary Purpose
Hypotension Drug-Induced
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ringer
Voluven
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension Drug-Induced
Eligibility Criteria
Inclusion Criteria:
- Age : 18-40 years
- ASA 1&2
Exclusion Criteria:
- Patients with morbid obesity.
- Pre-existing or pregnancy-induced hypertension.
- Known cardiovascular or cerebrovascular disease.
- Abnormal CTG tracing.
- Any other contraindications for intrathecal anaesthesia.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ringer
Voluven
Arm Description
This group will receive 1 L of Ringer's solution as a preload
This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload
Outcomes
Primary Outcome Measures
Incidence of hypotension
Decrease in systolic blood pressure more than 20% of base line
Secondary Outcome Measures
Perfusion index
Derived from pulse oximeter
Heart rate
Urine output
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03465943
Brief Title
Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia
Official Title
Crystalloid Versus Crystalloid and Colloid Combination Preload for Prevention of Hypotension in Patients Undergoing Elective Caesarean Section Under Intrathecal Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Intrathecal anesthesia is the most commonly used technique for elective Caesarean section all over the world.
One of the most common complications of this technique is hypotension. It's incidence is more than 80% without any prophylactic measures, this hypotension has adverse effects on both mother ( causing nausea and vomiting ) and foetus ( causing acidosis and neurological defects ).
This complication can be managed by several ways like fluid therapy, usage of vasopressors or combination between both of them.
Among the type of fluids ( crystalloid or colloid ) it's still not known which one of them is better. Crystalloid has a short intravascular half-life because of its rapid distribution into the interstitial space. On the other hand colloid remains longer within the intravascular space.
Change in baseline peripheral vascular tone due to pregnancy may affect the degree of such hypotension. The perfusion index ( PI ) derived from a pulse oximeter has been used for assessing peripheral perfusion dynamics due to changes in peripheral vascular tone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension Drug-Induced
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ringer
Arm Type
Active Comparator
Arm Description
This group will receive 1 L of Ringer's solution as a preload
Arm Title
Voluven
Arm Type
Active Comparator
Arm Description
This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload
Intervention Type
Drug
Intervention Name(s)
Ringer
Other Intervention Name(s)
Crystalloid
Intervention Description
1L of Ringer's solution as a preload in one group.
Intervention Type
Drug
Intervention Name(s)
Voluven
Other Intervention Name(s)
Hydroxyethyl starch 6%
Intervention Description
500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.
Primary Outcome Measure Information:
Title
Incidence of hypotension
Description
Decrease in systolic blood pressure more than 20% of base line
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Perfusion index
Description
Derived from pulse oximeter
Time Frame
1 hour
Title
Heart rate
Time Frame
1 hour
Title
Urine output
Time Frame
1 hour
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age : 18-40 years
ASA 1&2
Exclusion Criteria:
Patients with morbid obesity.
Pre-existing or pregnancy-induced hypertension.
Known cardiovascular or cerebrovascular disease.
Abnormal CTG tracing.
Any other contraindications for intrathecal anaesthesia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Essam E. Abd El-Hakeem, PhD
Phone
01207159716
Email
Essam1993@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nagwa Mostafa Osman, PhD
Phone
01006792219
Email
nagwaosman1962@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
25501602
Citation
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.
Results Reference
background
PubMed Identifier
15758080
Citation
Ngan 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.
Results Reference
result
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Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia
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