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.
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.
- 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
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 group | Role | What they receive |
|---|---|---|
| colloid preload | Experimental | 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. Receives: Drug: colloid preload |
| crystalloid coload | Placebo comparator | 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. Receives: Drug: colloid preload |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
incidence of severe hypotension
severe hypotension is defined by decreasing of systolic arterial blood pressure below 80 mmHg
Measured: 2 hours
total ephedrine dose
Measured: 2 hours
nausea and vomiting
number of nausea and vomiting episode
Measured: 2 hours
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.
- First posted11 Apr 2017
- Study startMar 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Mahdia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Majdoub Ali MD, University Hospital, Mahdia
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colloid Preload Versus Crystalloid Co-load in Cesarean Section Under Spinal Anesthesia Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03107598
- Acronym / sponsor ID
- CPvsCC / LCS
- Conditions
- Hypotension
- Keywords
- spinal anesthesia, neonatal outcome, Caesarean Section
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University Hospital, MahdiaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colloid preload | Experimental | Drug: colloid preloadGroup 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. |
| crystalloid coload | Placebo comparator | Drug: colloid preloadGroup 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colloid preloadAlso: crystalloid coloadcoparaison between colloid and crystalloide loading in spinal anesthesia for cesarean section | Drug | colloid preload, crystalloid coload |
Primary outcome
The primary outcome was the incidence of hypotension
Time frame: 2 hours
hypotension defined by decreasing of arterial blood pressure under 20% of base line
4 secondary outcomes
incidence of severe hypotension
Time frame: 2 hours
total ephedrine dose
Time frame: 2 hours
nausea and vomiting
Time frame: 2 hours
neonatal outcome
Time frame: 2 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.