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

Hypotension Drug-Induced Clinical Trial

Official title:

Crystalloid Versus Crystalloid and Colloid Combination Preload for Prevention of Hypotension in Patients Undergoing Elective Caesarean Section Under Intrathecal Anesthesia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03465943
• Other study ID #: Hypotension in elective CS
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: March 3, 2018
• Last updated: March 8, 2018
• Start date: March 2018
• Est. completion date: April 2019

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: Essam E. Abd El-Hakeem, PhD
• Phone: 01207159716
• Email: Essam1993[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Hypotension Drug-Induced

Intervention

Drug:
• Ringer
1L of Ringer's solution as a preload in one group.
• Voluven
500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

Ngan Kee WD. Confidential enquiries into maternal deaths: 50 years of closing the loop. Br J Anaesth. 2005 Apr;94(4):413-6. — View Citation

Ripollés Melchor J, Espinosa Á, Martínez Hurtado E, Casans Francés R, Navarro Pérez 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypotension	Decrease in systolic blood pressure more than 20% of base line	1 hour
Secondary	Perfusion index	Derived from pulse oximeter	1 hour
Secondary	Heart rate		1 hour
Secondary	Urine output		1 hour