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

Colloid Preload Versus Crystalloid Co-load in Cesarean Section Under Spinal Anesthesia Randomized Controlled Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03107598
Acronym
CPvsCC
Enrollment
127
Registered
2017-04-11
Start date
2016-03-31
Completion date
2016-09-30
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension

Keywords

spinal anesthesia, neonatal outcome, Caesarean Section

Brief summary

Comparison between colloid preload and crystalloid co-load in cesarean section under spinal anesthesia. 1. The primary outcome was the incidence of hypotension 2. 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.

Interventions

coparaison between colloid and crystalloide loading in spinal anesthesia for cesarean section

Sponsors

University Hospital, Mahdia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome was the incidence of hypotension2 hourshypotension defined by decreasing of arterial blood pressure under 20% of base line

Secondary

MeasureTime frameDescription
incidence of severe hypotension2 hourssevere hypotension is defined by decreasing of systolic arterial blood pressure below 80 mmHg
total ephedrine dose2 hours
nausea and vomiting2 hoursnumber of nausea and vomiting episode
neonatal outcome2 hoursumbilical arterial blood gas and APGAR scors at 1 and 5 minutes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026