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HypotensionCPvsCCNCT03107598

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

A study testing colloid preload in people with Hypotension, run by University Hospital, Mahdia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Hypotension
What is being tested?
colloid preload
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
127 participants
Where
No sites listed yet
Study dates
Mar 2016to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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
Read the 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.
Conditions
Hypotension
Being tested
colloid preload
Keywords
spinal anesthesia, neonatal outcome, Caesarean Section
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • colloid preloadDrug

    Also called crystalloid coload

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

Study groups in NCT03107598
Study groupRoleWhat they receive
colloid preloadExperimentalGroup 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.
Receives: Drug: colloid preload
crystalloid coloadPlacebo comparatorGroup 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.
Receives: Drug: colloid preload

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome was the incidence of hypotension

    hypotension defined by decreasing of arterial blood pressure under 20% of base line

    Measured: 2 hours

Secondary outcomes (4)
  1. incidence of severe hypotension

    severe hypotension is defined by decreasing of systolic arterial blood pressure below 80 mmHg

    Measured: 2 hours

  2. total ephedrine dose

    Measured: 2 hours

  3. nausea and vomiting

    number of nausea and vomiting episode

    Measured: 2 hours

  4. neonatal outcome

    umbilical arterial blood gas and APGAR scors at 1 and 5 minutes

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2017
  2. Study startMar 2016
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03107598
Sponsor's protocol ID
LCS
Acronym
CPvsCC
Status last verified
Apr 2017
First submitted
30 Dec 2016
Last updated
11 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing colloid preload in people with Hypotension, run by University Hospital, Mahdia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome was the incidence of hypotension (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.

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