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Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia

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ClinicalTrials.gov Identifier: NCT03465943
Recruitment Status : Unknown
Verified March 2018 by Rafeek Ramez Shawky Aziz, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Rafeek Ramez Shawky Aziz, Assiut University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hypotension Drug-Induced Drug: Ringer Drug: Voluven Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Crystalloid Versus Crystalloid and Colloid Combination Preload for Prevention of Hypotension in Patients Undergoing Elective Caesarean Section Under Intrathecal Anesthesia
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Hextend

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ringer
This group will receive 1 L of Ringer's solution as a preload
 Drug: Ringer
1L of Ringer's solution as a preload in one group.
Other Name: Crystalloid
Active Comparator: Voluven
This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload
 Drug: Ringer
1L of Ringer's solution as a preload in one group.
Other Name: Crystalloid

Drug: Voluven
500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.
Other Name: Hydroxyethyl starch 6%


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of hypotension [ Time Frame: 1 hour ]
    Decrease in systolic blood pressure more than 20% of base line


Secondary Outcome Measures :
  1. Perfusion index [ Time Frame: 1 hour ]
    Derived from pulse oximeter

  2. Heart rate [ Time Frame: 1 hour ]
  3. Urine output [ Time Frame: 1 hour ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465943


Contacts
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Contact: Essam E. Abd El-Hakeem, PhD 01207159716 Essam1993@yahoo.com
Contact: Nagwa Mostafa Osman, PhD 01006792219 nagwaosman1962@yahoo.com

Sponsors and Collaborators
Assiut University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Rafeek Ramez Shawky Aziz, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03465943    
Other Study ID Numbers: Hypotension in elective CS
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases