Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery

Cesarean Section Clinical Trial

Official title:

Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961842
• Other study ID #: R/16.09.64
• Status: Completed
• Phase: N/A
• First received: November 9, 2016
• Last updated: March 20, 2017
• Start date: November 20, 2016
• Est. completion date: March 9, 2017

Study information

• Verified date: March 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia.

Description:

This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Participants will receive either 500 mL colloid preload and 500 mL crystalloid coload (Combination group) or 1000 mL crystalloid coload (Coload group). Systolic blood pressure will be recorded every minute and ephedrine will be administered when hypotension occurs according to a predefined protocol. The total ephedrine dose, time to the first ephedrine dose, heart rate, inferior vena cava diameter, nausea/vomiting, and neonatal Apgar scores will be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 9, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status II parturients

• Full term, singleton pregnancy

• Elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

• Age <19 or > 40 years

• Height <150 cm

• Weight <60 kg

• Body mass index =40 kg/m2

• Contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection)

• Chronic or pregnancy-induced hypertension

• Hemoglobin <10 gm/dL.

• Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease

• Polyhydramnios or known fetal abnormalities

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Cesarean Section

Intervention

Drug:
• 500 mL Colloid Preload
6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia

Procedure:
• Spinal Anesthesia
Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle

Drug:
• Intrathecal Bupivacaine
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
• Intrathecal Fentanyl
Fentanyl 15 µg will be administered in the subarachnoid space
• 500 mL Crystalloid Coload
Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection
• 1000 mL Crystalloid Coload
Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection

Procedure:
• Cesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision

Radiation:
• Ultrasound Assessment of the Inferior Vena Cava
The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 5-2 MHz curved array ultrasound probe placed longitudinally in the subxiphoid region

Drug:
• Intravenous Ephedrine
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total ephedrine dose		intraoperative
Secondary	Incidence of hypotension	Hypotension: Systolic blood pressure <80% of baseline	intraoperative
Secondary	Incidence of severe hypotension	Severe hypotension: Systolic blood pressure <70% of baseline	intraoperative
Secondary	Time to the first ephedrine dose		intraoperative
Secondary	Heart rate		intraoperative
Secondary	Inferior vena cava largest and smallest diameters		Baseline, at 1 and 5 minutes after intrathecal injection, delivery
Secondary	Inferior vena cava collapsibility index	Collapsibility index = (Largest diameter - Smallest diameter) / Largest diameter	Baseline, at 1 and 5 minutes after intrathecal injection, delivery
Secondary	Incidence of nausea and/or vomiting		intraoperative
Secondary	Neonatal Apgar score		At 1 and 5 minutes after delivery