- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03465943
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Essam E. Abd El-Hakeem, PhD
- Phone Number: 01207159716
- Email: Essam1993@yahoo.com
Study Contact Backup
- Name: Nagwa Mostafa Osman, PhD
- Phone Number: 01006792219
- Email: nagwaosman1962@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Ringer
This group will receive 1 L of Ringer's solution as a preload
|
1L of Ringer's solution as a preload in one group.
Other Names:
|
ACTIVE_COMPARATOR: Voluven
This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload
|
1L of Ringer's solution as a preload in one group.
Other Names:
500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of hypotension
Time Frame: 1 hour
|
Decrease in systolic blood pressure more than 20% of base line
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perfusion index
Time Frame: 1 hour
|
Derived from pulse oximeter
|
1 hour
|
Heart rate
Time Frame: 1 hour
|
1 hour
|
|
Urine output
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hypotension in elective CS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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