Clinical trial NCT02961842: Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery
Official title: Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Spinal
Cesarean Section
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total ephedrine dose
timeFrame: intraoperative
Secondary outcomes:
measure: Incidence of hypotension
timeFrame: intraoperative
measure: Incidence of severe hypotension
timeFrame: intraoperative
measure: Time to the first ephedrine dose
timeFrame: intraoperative
measure: Heart rate
timeFrame: intraoperative
measure: Inferior vena cava largest and smallest diameters
timeFrame: Baseline, at 1 and 5 minutes after intrathecal injection, delivery
measure: Inferior vena cava collapsibility index
timeFrame: Baseline, at 1 and 5 minutes after intrathecal injection, delivery
measure: Incidence of nausea and/or vomiting
timeFrame: intraoperative
measure: Neonatal Apgar score
timeFrame: At 1 and 5 minutes after delivery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Department of Anesthesia, Mansoura University Hospitals
state: Dakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Mohamed M Tawfik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tawfik MM, Tarbay AI, Elaidy AM, Awad KA, Ezz HM, Tolba MA. Combined Colloid Preload and Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery: A Randomized Controlled Trial. Anesth Analg. 2019 Feb;128(2):304-312. doi: 10.1213/ANE.0000000000003306.