Complications; Anesthesia, Spinal and Epidural, in PregnancyNCT02680678
The Effect of the Timing of Colloid and Crystalloid Infusions on Postspinal Hypotension After Spinal Anesthesia for Caesarian Section
A study testing Colloid Preload, colloid co-load and Crystalloid preload in people with Complications; Anesthesia, Spinal and Epidural, in Pregnancy, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid infusions and their timing via perfusion index and plethysmographic variability index. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications; Anesthesia, Spinal and Epidural, in Pregnancy
- What is being tested?
- Colloid Preload, colloid co-load and Crystalloid preload
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2014to Dec 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant 37-41 weeks
- one fetus
- scheduled for C/S under spinal anesthesia
- accepting to participate
Who cannot join
- Emergency surgery
- placenta previa
- preeclampsia
- cardiovascular and cerebrovascular comorbidities
- morbid obesity (BMI>40)
- pregnancy weeks <36 and > 41
Show all 9Show fewer
- The use of vasoconstrictors
- Severe Anemia ( Hb <9 g/dl)
- Refusal or known contraindication for spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balikesir University Faculty of Medicine
Balıkesir, 10145
About this study
Official title: Prevention of Postspinal Hypotension After Spinal Anesthesia for Caesarian Section, the Comparison of Crystalloid and Colloid Infusions and Their Timing Via Perfusion Index and Plethysmographic Variability Index
Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid infusions and their timing via perfusion index and plethysmographic variability index.
Read the detailed description
To Prevent hypotension fluid replacement is usually used in pregnant patients scheduled for C/S. Different types of fluids can be used in order to achieve this. Also the timing of fluid replacement is important. In the present study patients were separated into 4 groups. Each receiving a one of two fluids in different times. ( Colloid pre-load, colloid co-load, crystalloid co-load and crystalloid pre-load.) The effect of overall hemodynamics and the incidence of hypotension are evaluated. Also peripheric monitors like perfusion index and plethysmographic variability index are evaluated for correlation.
- Being tested
- Colloid Preload, colloid co-load, Crystalloid preload, Crystalloid Co-load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colloid PreloadOther
Also called Gelofusin
preload infusion
colloid co-loadOther
Also called gelofusin
co-load infusion
Crystalloid preloadOther
Also called Ringers lactate solution
preload infusion
Crystalloid Co-loadOther
Also called Ringers lactate solution
co-load infusion
| Study group | Role | What they receive |
|---|---|---|
| Colloid preload | Active comparator | 20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) 15 minutes before spinal anesthesia. Receives: Other: Colloid Preload |
| Colloid Co-load | Active comparator | 20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) beginning with spinal anesthesia. Receives: Other: colloid co-load |
| Crystalloid Preload | Active comparator | 20 patients each patient receives 20 ml/kg of Ringer's lactate solution 15 minutes before spinal anesthesia. Receives: Other: Crystalloid preload |
| Crystalloid Co-load | Active comparator | 20 patients each patient receives 20 ml/kg of Ringer's lactate solution beginning with spinal anesthesia. Receives: Other: Crystalloid Co-load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores
Hypotension is going tobe measured in mmHG in 5 minute intervals and PI and PVI measurements are also recorded at the same time intervals. A decrease in blood presssure exceeding % 20 of the preoperative basal blood pressure measurement will be recorded as hypotension. The number of patients who develop hypotension will be recorded. Statistic difference will be avaluated between groups. Hypotensive episodes are going to be comparised with the PI and PVI measurements at the same time period and evaluation for correlation will be performed.
Measured: Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startApr 2014
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Anesthesia, Spinal and Epidural, in PregnancyStudies 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
- Model description
- 4 group of patients were sheduled to receive either kristalloid or kolloid two gropus before and two groups during anesthesia induction
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hafize fisun demir, Balikesir University
- Investigators
- Hafize Fisun Demir, Principal investigator, Balikesir University School of Medicine Department of Anesthesia and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680678
- Sponsor's protocol ID
- BAU
- Status last verified
- Jan 2020
- First submitted
- 9 Feb 2016
- Last updated
- 22 Jan 2020
- 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 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postspinal Hypotension After Spinal Anesthesia for Caesarian Section, the Comparison of Crystalloid and Colloid Infusions and Their Timing Via Perfusion Index and Plethysmographic Variability Index
- ClinicalTrials.gov ID
- NCT02680678
- Acronym / sponsor ID
- BAU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Feb 2016 (estimated)
- 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.
Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid infusions and their timing via perfusion index and plethysmographic variability index.
Detailed description
To Prevent hypotension fluid replacement is usually used in pregnant patients scheduled for C/S. Different types of fluids can be used in order to achieve this. Also the timing of fluid replacement is important. In the present study patients were separated into 4 groups. Each receiving a one of two fluids in different times. ( Colloid pre-load, colloid co-load, crystalloid co-load and crystalloid pre-load.) The effect of overall hemodynamics and the incidence of hypotension are evaluated. Also peripheric monitors like perfusion index and plethysmographic variability index are evaluated for correlation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 group of patients were sheduled to receive either kristalloid or kolloid two gropus before and two groups during anesthesia induction
| Arm | Type | Receives |
|---|---|---|
| Colloid preload | Active comparator | Other: Colloid Preload20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) 15 minutes before spinal anesthesia. |
| Colloid Co-load | Active comparator | Other: colloid co-load20 patients each patient receives 7 ml/kg of gelatin solution (gelofusin) beginning with spinal anesthesia. |
| Crystalloid Preload | Active comparator | Other: Crystalloid preload20 patients each patient receives 20 ml/kg of Ringer's lactate solution 15 minutes before spinal anesthesia. |
| Crystalloid Co-load | Active comparator | Other: Crystalloid Co-load20 patients each patient receives 20 ml/kg of Ringer's lactate solution beginning with spinal anesthesia. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- pregnant 37-41 weeks
- one fetus
- scheduled for C/S under spinal anesthesia
- accepting to participate
Key exclusion criteria (9 listed)
- Emergency surgery
- placenta previa
- preeclampsia
- cardiovascular and cerebrovascular comorbidities
- morbid obesity (BMI>40)
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: Gelofusinpreload infusion | Other | Colloid preload |
| colloid co-loadAlso: gelofusinco-load infusion | Other | Colloid Co-load |
| Crystalloid preloadAlso: Ringers lactate solutionpreload infusion | Other | Crystalloid Preload |
| Crystalloid Co-loadAlso: Ringers lactate solutionco-load infusion | Other | Crystalloid Co-load |
Primary outcome
Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores
Time frame: Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end.
Hypotension is going tobe measured in mmHG in 5 minute intervals and PI and PVI measurements are also recorded at the same time intervals. A decrease in blood presssure exceeding % 20 of the preoperative basal blood pressure measurement will be recorded as hypotension. The number of patients who develop hypotension will be recorded. Statistic difference will be avaluated between groups. Hypotensive episodes are going to be comparised with the PI and PVI measurements at the same time period and evaluation for correlation will be performed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- 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.
Hafize Fisun Demir principal investigator
Balikesir University School of Medicine Department of Anesthesia and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colloid Preload, colloid co-load and Crystalloid preload in people with Complications; Anesthesia, Spinal and Epidural, in Pregnancy, run by Balikesir University at 1 site in Turkey (Türkiye).
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 9 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: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants in each group who develop hypotension, and correlation between hypotension and Perfusion Index (PI) and Plethysmographic Variability Index (PVI) scores (time frame: Measurements will be performed at 5 minute intervals beginning 15 minutes prior to the operation, throughout the whole operation untill the end.). 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 22 Jan 2020.