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

March 8, 2018 updated by: Rafeek Ramez Shawky Aziz, Assiut University

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

Unknown

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Ringer
1L of Ringer's solution as a preload in one group.
Other Names:
  • 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 Names:
  • 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 Names:
  • Hydroxyethyl starch 6%

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

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2018

Primary Completion (ANTICIPATED)

March 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

March 3, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (ACTUAL)

March 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

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

No

Studies a U.S. FDA-regulated device product

No

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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