Skip to main content
OpenTrials
Completed

NCT Number: NCT02961842

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia, Spinal Cesarean Section

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesia, Mansoura University Hospitals

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

500 mL Colloid Preload

Drug

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

Spinal anesthesia

Procedure

Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle

Intrathecal Bupivacaine

Drug

Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space

Intrathecal Fentanyl

Drug

Fentanyl 15 µg will be administered in the subarachnoid space

500 mL Crystalloid Coload

Drug

Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection

1000 mL Crystalloid Coload

Drug

Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection

Cesarean Delivery

Procedure

Lower segment cesarean section using the Pfannenstiel incision

Ultrasound Assessment of the Inferior Vena Cava

Radiation

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

Intravenous Ephedrine

Drug

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

Primary outcomes

  1. Total ephedrine dose

    Time frame: intraoperative

Secondary outcomes

  1. Incidence of hypotension

    Time frame: intraoperative

    Hypotension: Systolic blood pressure <80% of baseline

  2. Incidence of severe hypotension

    Time frame: intraoperative

    Severe hypotension: Systolic blood pressure <70% of baseline

  3. Time to the first ephedrine dose

    Time frame: intraoperative

  4. Heart rate

    Time frame: intraoperative

  5. Inferior vena cava largest and smallest diameters

    Time frame: Baseline, at 1 and 5 minutes after intrathecal injection, delivery

  6. Inferior vena cava collapsibility index

    Time frame: Baseline, at 1 and 5 minutes after intrathecal injection, delivery

    Collapsibility index = (Largest diameter - Smallest diameter) / Largest diameter

  7. Incidence of nausea and/or vomiting

    Time frame: intraoperative

  8. Neonatal Apgar score

    Time frame: At 1 and 5 minutes after delivery

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2016
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.