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

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ClinicalTrials.gov Identifier: NCT02961842
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Mohamed Tawfik, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Anesthesia, Spinal Cesarean Section Drug: 500 mL Colloid Preload Procedure: Spinal Anesthesia Drug: Intrathecal Bupivacaine Drug: Intrathecal Fentanyl Drug: 500 mL Crystalloid Coload Drug: 1000 mL Crystalloid Coload Procedure: Cesarean Delivery Radiation: Ultrasound Assessment of the Inferior Vena Cava Drug: Intravenous Ephedrine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery
Actual Study Start Date : November 20, 2016
Actual Primary Completion Date : March 9, 2017
Actual Study Completion Date : March 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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: 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

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.
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

Drug: Intrathecal Fentanyl
Fentanyl 15 µg will be administered in the subarachnoid space

Drug: 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.




Primary Outcome Measures :
  1. Total ephedrine dose [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961842


Locations
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Egypt
Department of Anesthesia, Mansoura University Hospitals
Mansoura, Dakahlia, Egypt, 35511
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Mohamed M Tawfik, MD Mansoura University Hospitals

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Responsible Party: Mohamed Mohamed Tawfik, Lecturer, Department of anesthesia and surgical intensive care, principal investigator, Mansoura University
ClinicalTrials.gov Identifier: NCT02961842     History of Changes
Other Study ID Numbers: R/16.09.64
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Ephedrine
Nasal Decongestants
Anesthetics
Bupivacaine
Fentanyl
Pseudoephedrine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Vasoconstrictor Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents