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Colloid Preload Versus Crystalloid Co-load in Cesarean Section Under Spinal Anesthesia (CPvsCC)

Primary Purpose

Hypotension

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
colloid preload
Sponsored by
University Hospital, Mahdia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring spinal anesthesia, neonatal outcome, Caesarean Section

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged between 18 and 40 years' old
  • American Society of Anesthesiologists physical status I or II (ASA)
  • Full-term singleton pregnancy
  • scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

  • cardiovascular, cerebrovascular or renal disease
  • multiple gestations
  • polyhydramnios or known fetal abnormalities
  • allergy to local anesthetics or opioids
  • emergency Cesarean section or parturient that have failed vaginal delivery with epidural analgesia
  • contraindications for performing spinal anesthesia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    colloid preload

    crystalloid coload

    Arm Description

    Group CoP: group with colloid preload The preload group received rapid infusion of 15ml/kg of 6% hydroxyethyl starch (6% HES) administered by gravity at a wide-open rate over a period of 15-30min before induction of spinal anesthesia.

    Group CrC: group with crystalloid coload The coload group received a sodium chloride 0.9% perfusion as rapidly as possible starting at the time of intrathecal injection for spinal anesthesia.

    Outcomes

    Primary Outcome Measures

    The primary outcome was the incidence of hypotension
    hypotension defined by decreasing of arterial blood pressure under 20% of base line

    Secondary Outcome Measures

    incidence of severe hypotension
    severe hypotension is defined by decreasing of systolic arterial blood pressure below 80 mmHg
    total ephedrine dose
    nausea and vomiting
    number of nausea and vomiting episode
    neonatal outcome
    umbilical arterial blood gas and APGAR scors at 1 and 5 minutes

    Full Information

    First Posted
    December 30, 2016
    Last Updated
    April 4, 2017
    Sponsor
    University Hospital, Mahdia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03107598
    Brief Title
    Colloid Preload Versus Crystalloid Co-load in Cesarean Section Under Spinal Anesthesia
    Acronym
    CPvsCC
    Official Title
    Colloid Preload Versus Crystalloid Co-load in Cesarean Section Under Spinal Anesthesia Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Terminated
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Mahdia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Comparison between colloid preload and crystalloid co-load in cesarean section under spinal anesthesia. The primary outcome was the incidence of hypotension Secondary outcomes included the incidence of severe hypotension, total ephedrine dose, nausea and vomiting and neonatal outcome assessed by Apgar scores and umbilical artery blood gas analysis
    Detailed Description
    It's a prospective randomized study, during 7 months between march and September 2016, carry on department of anesthesia and intensive care and department of obstetrics and gynecology, at Taher Sfar Mahdia University Hospital. investigators included participants: Aged between 18 and 40 years' old American Society of Anesthesiologists physical status I or II (ASA) Full-term singleton pregnancy scheduled for elective cesarean section under spinal anesthesia Parturients were excluded if : participants younger than 18 or older than 40 years cardiovascular, cerebrovascular or renal disease multiple gestations polyhydramnios or known fetal abnormalities allergy to local anesthetics or opioids emergency Cesarean section or parturient that have failed vaginal delivery with epidural analgesia contraindications for performing spinal anesthesia in this study no premedication was given. Patients entered the operating room and lay supine with 15° of left lateral tilt on the operating table. Standard monitors of electrocardiography, pulse oximetry (Spo2), and noninvasive blood pressure were applied on the right arm. Baseline systolic and diastolic blood pressure (SBP, DPB) and heart rates (HR) were recorded. An 18 or 16-gauge intravenous cannula was inserted in a large forearm vein.Patients were randomly assigned into two groups: colloid preload (CoP), and crystalloid co-load (CrC).Group CoP: group with colloid preload The preload group received rapid infusion of 15ml/kg of 6% hydroxyethyl starch (6% HES, voluven) administered by gravity at a wide-open rate over a period of 15-30min before induction of spinal anesthesia.Group CrC: group with crystalloid coload received a sodium chloride 0.9% perfusion as rapidly as possible starting at the time of intrathecal injection. Spinal anesthesia was performed in the sitting position with a 27- or 25-gauge spinal needle at the L3-4 or L2-3 interspace using hyperbaric bupivacaine 10 mg (0.5% hyperbaric bupivacaine 2 mL), sufentanyl 2.5 µg (0.5 ml) and 100µg morphine (1ml). All patients received the same dose regardless of height or weight. After completing the anesthetic procedure, patients were immediately repositioned to supine with a 15°-30° left lateral tilt. The highest sensory block was checked and confirmed at the level of T3-T5 determined with loss-to-pinprick method bilaterally at 5 minutes and 10 minutes after spinal drug administration. Motor block was measured with modified Bromage scale (0, no block; 1, inability to raise extended leg;2, inability to flex knee; 3, inability to flex ankle and foot). Oxygen was routinely given: 5 l/min was administrated via a clear facemask. After umbilical cord clamping, prophylactic antibiotic treatment was administrated intravenously whether 2g of cefazolin or 600mg of clindamycin if the parturient was allergic to penicillin.After delivery of the baby, 10 UI of oxytocin was intravenously given, and 15 UI was titrated following lactate ringer's solution. Hypotension was defined as a 20% reduction of systolic blood pressure from baseline .Severe hypotension defined as SBP < 80 mmhg. It was treated with an intravenous ephedrine bolus: 70% ≤ SBP < 80% from baseline value: ephedrine 6mg SBP < 70% from baseline value: ephedrine 9mg SBP < 60% from baseline value: ephedrine 12mg Vasopressor treatment was repeated every 2 minutes if hypotension persisted or recurred.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypotension
    Keywords
    spinal anesthesia, neonatal outcome, Caesarean Section

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    127 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    colloid preload
    Arm Type
    Experimental
    Arm Description
    Group CoP: group with colloid preload The preload group received rapid infusion of 15ml/kg of 6% hydroxyethyl starch (6% HES) administered by gravity at a wide-open rate over a period of 15-30min before induction of spinal anesthesia.
    Arm Title
    crystalloid coload
    Arm Type
    Placebo Comparator
    Arm Description
    Group CrC: group with crystalloid coload The coload group received a sodium chloride 0.9% perfusion as rapidly as possible starting at the time of intrathecal injection for spinal anesthesia.
    Intervention Type
    Drug
    Intervention Name(s)
    colloid preload
    Other Intervention Name(s)
    crystalloid coload
    Intervention Description
    coparaison between colloid and crystalloide loading in spinal anesthesia for cesarean section
    Primary Outcome Measure Information:
    Title
    The primary outcome was the incidence of hypotension
    Description
    hypotension defined by decreasing of arterial blood pressure under 20% of base line
    Time Frame
    2 hours
    Secondary Outcome Measure Information:
    Title
    incidence of severe hypotension
    Description
    severe hypotension is defined by decreasing of systolic arterial blood pressure below 80 mmHg
    Time Frame
    2 hours
    Title
    total ephedrine dose
    Time Frame
    2 hours
    Title
    nausea and vomiting
    Description
    number of nausea and vomiting episode
    Time Frame
    2 hours
    Title
    neonatal outcome
    Description
    umbilical arterial blood gas and APGAR scors at 1 and 5 minutes
    Time Frame
    2 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Aged between 18 and 40 years' old American Society of Anesthesiologists physical status I or II (ASA) Full-term singleton pregnancy scheduled for elective cesarean section under spinal anesthesia Exclusion Criteria: cardiovascular, cerebrovascular or renal disease multiple gestations polyhydramnios or known fetal abnormalities allergy to local anesthetics or opioids emergency Cesarean section or parturient that have failed vaginal delivery with epidural analgesia contraindications for performing spinal anesthesia

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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