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
About this trial
This is an interventional prevention trial for Hypotension focused on measuring spinal anesthesia, neonatal outcome, Caesarean Section
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
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
NCT ID
NCT03107598
First Posted
December 30, 2016
Last Updated
April 4, 2017
Sponsor
University Hospital, Mahdia
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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Colloid Preload Versus Crystalloid Co-load in Cesarean Section Under Spinal Anesthesia
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