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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Anesthesia, Spinal
• Intervention / Treatment: Drug: Intrathecal Bupivacaine; Drug: 500 mL Colloid Preload; Procedure: Spinal Anesthesia; Drug: Intrathecal Fentanyl; Drug: 500 mL Crystalloid Coload; Procedure: Cesarean Delivery; Radiation: Ultrasound Assessment of the Inferior Vena Cava; Drug: Intravenous Ephedrine; Drug: 1000 mL Crystalloid Coload

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Department of Anesthesia, Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination; 500 mL colloid preload and 500 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered.	Drug: Intrathecal Bupivacaine; Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space; 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 Fentanyl; Fentanyl 15 µg will be administered in the subarachnoid space; Drug: 500 mL Crystalloid Coload; Ringer acetate 500 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.
Active Comparator: Coload; 1000 mL crystalloid coload. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine will be administered.	Drug: Intrathecal Bupivacaine; Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space; Procedure: Spinal Anesthesia; Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle; Drug: Intrathecal Fentanyl; Fentanyl 15 µg will be administered in the subarachnoid space; 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.; Drug: 1000 mL Crystalloid Coload; Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total ephedrine dose	intraoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mansoura University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2016
• Primary Completion (Actual): March 9, 2017
• Study Completion (Actual): March 9, 2017

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): March 22, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Fentanyl; Bupivacaine; Ephedrine
• Other Study ID Numbers: R/16.09.64

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No