Effects of Anesthesia Spinal and Epidural in PregnancyNCT05174260
The Relationship Between Perfusion Index and Pleth Variability Index and Hemodynamics in Spinal Anesthesia
An observational study of Effects of Anesthesia Spinal and Epidural in Pregnancy, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
In routine practice, the preferred anesthesia method in cesarean section operations is spinal anesthesia, but it causes hypotension in a significant part of the patients. In this study, the researchers planned to evaluate the perfusion index (PI) and pleth variability index (PVI) values at different positions to… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Effects of Anesthesia Spinal and Epidural in Pregnancy
- What is being tested?
- perfusion index, pleth variable index
- Type of treatment
- Medical device
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2021to 11 Aug 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- Adult
Study population: Female patients aged 18-40 who will undergo elective cesarean section
Who may be able to join
- Pregnant women who will undergo elective cesarean section
- Patients with ASA 1-2
- Patients aged 18-40 years
Who cannot join
- Emergency cases
- <18 or > 40 years old
- Gestational age <36 weeks
- BMI ≥40
- Cardiovascular disease
- Patients with ASA 3-4
Show all 9Show fewer
- Those with peripheral vascular disease
- Patients for whom spinal anesthesia is contraindicated
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictability of Hemodynamic Instability With Increase in Perfusion Index (PI) and Pleth Variability Index (PVI) Values After Spinal Block in Elective Cesarean Sections
In routine practice, the preferred anesthesia method in cesarean section operations is spinal anesthesia, but it causes hypotension in a significant part of the patients. In this study, the researchers planned to evaluate the perfusion index (PI) and pleth variability index (PVI) values at different positions to predict hypotension after spinal anesthesia applied for cesarean section. When hypotension is severe and persistent, it may cause uteroplacental perfusion disorder, fetal hypoxia-acidosis, and neonatal neurological damage as well as nausea-vomiting, loss of consciousness, cardiac arrest and collapse in the mother(2) If hemodynamic changes such as hypotension and bradycardia are present, symptoms may occur. . Early intervention with vasoconstrictor agents will be provided to prevent the emergence of the disease, disturbing symptoms and other complications that may occur will be prevented.
Read the detailed description
In recent years, the trend towards noninvasive monitoring methods has increased instead of invasive monitoring methods. Plet Variability Index (PVI), perfusion index (PI) are non-invasive, easily applicable and easily interpretable new monitoring methods. It has been shown that intraoperative hypotension and fluid requirement can be predicted, especially with Plet Variability Index (PVI) monitoring. Hypotension is the most common complication of spinal anesthesia. If no precautions are taken, it is seen in 80-90% of cases. associated with a decrease in peripheral vascular resistance. Recent studies have shown that cardiac output does not decrease, but slightly increases or does not change, and venous return does not change with spinal anesthesia. Aortocaval compression may exacerbate hypotension due to neuraxial anesthesia. The PI is obtained by calculating the ratio of pulsatile blood flow to nonpulsatile blood flow in peripheral tissues by pulse oximetry. This ratio reflects changes in peripheral vascular resistance. For example, a low PI indicates peripheral vasoconstriction. PVI represents changes in PI that occur during one or more complete respiratory cycles. Provides evaluation of intravascular volume; and a higher PVI is associated with greater responsiveness to fluid volumes. In some studies, it is stated that PI and PVI values obtained from pulse oximetry are predictive for SA-induced hypotension in cesarean deliveries; There are also studies in the literature showing the opposite. In this study, the researchers aimed to test the hypothesis that hypotension can be predicted by using PVI representing cardiac preload and PI representing vascular tone in pregnant women after spinal anesthesia and to examine the superiority of these values.
OBJECTIVE: Today, spinal anesthesia (SA); Since it is less risky for maternal and new born health compared to general anesthesia, it is a more preferred method in elective cesareansection operations. Hypotension due to spinal anesthesia, which is the most common side effect of spinal anesthesia, is frequently seen in patients. Due to the negative consequences of hypotension on the mother and newborn; It is important to take the necessary precautions against this hemodynamic deterioration. Perfusion index (PI) and pleth variability index (PVI) are parameters that can be measured noninvasively by pulseoximetry. In our study; By examining the lower extremity PI and PVI values in patients who will undergo elective cesareansection with SA; We investigated the usability and superiority of these values over each other in predicting hemodynamic deterioration.
METHODS: This research; It was conducted as a prospective observational study and 113 pregnant women aged 18-40 years who were ASA1-2 who were going to undergo lower segment cesarean section were included in our study. Demographic data of the patients (age, gender, weight, height, BMI) and routine hemogram values (hemoglobin, hematocrit, platelet, wbc) taken for preoperative evaluation were recorded. After the patients were placed on the operating table, PI and PVI values in the supine and sitting positions, PI and PVI values at the 1st, 2nd, 3rd, and 4th minutes after spinal anesthesia was applied to the patient, and finally, the postpartum PI, PVI values were recorded. In addition, in order to follow up the hemodynamic changes in all patients in thes tudy, Standard monitoring including electrocardiography, non-invasive blood pressure measurements and pulse measurement was performed, and changes in systolic pressure, diastolic pressure and heart rate were recorded before and after spinal anesthesia.
In our study, in which we examined PI and PVI values in predicting hypotension due to spinal anesthesia in elective C/S operations, we have reached the following results.
Unlike other studies in the literature; In our study, in which we followed the PI and PVI values in the lower extremities together and examined the diagnostic superiority of these values to each other and the relationship between the hemogram and hematocrit values of the patients, we did not find a statistically significant difference in the increase in the lower extremity basal PI and PVI values in the patient groups with and without hypotension. We interpreted this situation as lower extremity basal PI and PVI values were not effective in predicting hypotension due to spinal anesthesia.
We observed that there was no change in PI and PVI values in 5 patients who were not included in the study in whom spinal anesthesia failed, and that there was an increase in successful procedures independent of the development of significant hemodynamic instability. As a result, our study supported previous studies that PI and PVI values could be used to evaluate the success of spinal block.
In addition, we found that hgb and hct values were significantly lower in the hypotension-developing group in our study, but we found that this did not cause a significant difference in basal PI and PVI values. We think that the surgical HGB limit should be reconsidered in patients who will undergo elective surgery, due to the increased risk of hypotension if the patients have low hemogram values, and we believe that it would be beneficial to conduct more comprehensive multicenter studies in both cases.
- Being tested
- perfusion index, pleth variable index
- Keywords
- spinal anesthesia, perfusion index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion index, pleth variable indexDevice
Also called a latch will be attached to the patient's finger
a clip will be attached to the patient's finger and the perfusion index and pvi will be measured
| Study group | Role | What they receive |
|---|---|---|
| hypotension developing group | Pregnant women who underwent elective C/S under spinal anesthesia with systolic arterial pressure below 90 mmHg or with hypotension symptoms such as dizziness, nausea and vomiting during the procedure. Receives: Device: perfusion index, pleth variable index | |
| group without hypotension | Pregnant women who underwent elective cesarean section under spinal anesthesia whose systolic arterial pressure did not fall below 90 mmHg or did not have any symptoms of hypotension during the procedure. Receives: Device: perfusion index, pleth variable index |
What is being measured
The primary outcome is the main question the study is designed to answer.
perfusion index (PI)
Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and 1 more measurement will be made after routine oxytocin. Its relationship with hemodynamic deterioration will be examined and compared between both groups.In basal values of PI and the rate of change of these values; There was no significant difference between the groups with and without hypotension.
Measured: perioperative
pleth variability index (PVI)
Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and 1 more measurement will be made after routine oxytocin. Its relationship with hemodynamic deterioration will be examined and compared between both groups.In basal values of PVI and the rate of change of these values; There was no significant difference between the groups with and without hypotension.
Measured: perioperative
BMİ-weight,
There was no difference in BMI and weight values between patients who developed and did not develop hypotension after spinal anesthesia
Measured: preoperratif value
hemoglobin
Hemoglobin (p=0.014) and hematocrit (p=0.012) values weres ignificantly lower in pregnant women who developed hypotension
Measured: preoperatif value
APGAR
The 1st minute APGAR (p=0.005= and 5th minute APGAR (p=0.014) scores were significantly lower in the babies of pregnant women who developed hypotension.
Measured: the 1st minute APGAR-the 5th minute APGAR
Secondary outcomes (3)
systolic blood pressure
systolic blood pressure will be recorded
Measured: perioperative
diastolic blood pressure
diastolic blood pressure will be recorded
Measured: perioperative
pulse
pulse will be recorded
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start2 Dec 2021
- Primary completion2 Jan 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Effects of 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESMA KAPLAN ÇALIŞKAN, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174260
- Sponsor's protocol ID
- date:18/05/2021 ID:2021/05-23
- Other IDs
- öznur uludağ
- Status last verified
- Sep 2022
- First submitted
- 8 Nov 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: I am undecided about sharing individual participant data with other researchers.
Publications
Loubert C. Fluid and vasopressor management for Cesarean delivery under spinal anesthesia: continuing professional development. Can J Anaesth. 2012 Jun;59(6):604-19. doi: 10.1007/s12630-012-9705-9. Epub 2012 Apr 24. English, French.
PubMed 22528166Langesaeter E, Rosseland LA, Stubhaug A. Continuous invasive blood pressure and cardiac output monitoring during cesarean delivery: a randomized, double-blind comparison of low-dose versus high-dose spinal anesthesia with intravenous phenylephrine or placebo infusion. Anesthesiology. 2008 Nov;109(5):856-63. doi: 10.1097/ALN.0b013e31818a401f.
PubMed 18946298Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.
PubMed 18522935Tsuchiya M, Yamada T, Asada A. Pleth variability index predicts hypotension during anesthesia induction. Acta Anaesthesiol Scand. 2010 May;54(5):596-602. doi: 10.1111/j.1399-6576.2010.02225.x. Epub 2010 Mar 10.
PubMed 20236098
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of Hemodynamic Instability With Increase in Perfusion Index (PI) and Pleth Variability Index (PVI) Values After Spinal Block in Elective Cesarean Sections
- ClinicalTrials.gov ID
- NCT05174260
- Acronym / sponsor ID
- date:18/05/2021 ID:2021/05-23
- Keywords
- spinal anesthesia, perfusion index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 30 Dec 2021 (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.
In routine practice, the preferred anesthesia method in cesarean section operations is spinal anesthesia, but it causes hypotension in a significant part of the patients. In this study, the researchers planned to evaluate the perfusion index (PI) and pleth variability index (PVI) values at different positions to predict hypotension after spinal anesthesia applied for cesarean section. When hypotension is severe and persistent, it may cause uteroplacental perfusion disorder, fetal hypoxia-acidosis, and neonatal neurological damage as well as nausea-vomiting, loss of consciousness, cardiac arrest and collapse in the mother(2) If hemodynamic changes such as hypotension and bradycardia are present, symptoms may occur. . Early intervention with vasoconstrictor agents will be provided to prevent the emergence of the disease, disturbing symptoms and other complications that may occur will be prevented.
Detailed description
In recent years, the trend towards noninvasive monitoring methods has increased instead of invasive monitoring methods. Plet Variability Index (PVI), perfusion index (PI) are non-invasive, easily applicable and easily interpretable new monitoring methods. It has been shown that intraoperative hypotension and fluid requirement can be predicted, especially with Plet Variability Index (PVI) monitoring. Hypotension is the most common complication of spinal anesthesia. If no precautions are taken, it is seen in 80-90% of cases. associated with a decrease in peripheral vascular resistance. Recent studies have shown that cardiac output does not decrease, but slightly increases or does not change, and venous return does not change with spinal anesthesia. Aortocaval compression may exacerbate hypotension due to neuraxial anesthesia. The PI is obtained by calculating the ratio of pulsatile blood flow to nonpulsatile blood flow in peripheral tissues by pulse oximetry. This ratio reflects changes in peripheral vascular resistance. For example, a low PI indicates peripheral vasoconstriction. PVI represents changes in PI that occur during one or more complete respiratory cycles. Provides evaluation of intravascular volume; and a higher PVI is associated with greater responsiveness to fluid volumes. In some studies, it is stated that PI and PVI values obtained from pulse oximetry are predictive for SA-induced hypotension in cesarean deliveries; There are also studies in the literature showing the opposite. In this study, the researchers aimed to test the hypothesis that hypotension can be predicted by using PVI representing cardiac preload and PI representing vascular tone in pregnant women after spinal anesthesia and to examine the superiority of these values.
OBJECTIVE: Today, spinal anesthesia (SA); Since it is less risky for maternal and new born health compared to general anesthesia, it is a more preferred method in elective cesareansection operations. Hypotension due to spinal anesthesia, which is the most common side effect of spinal anesthesia, is frequently seen in patients. Due to the negative consequences of hypotension on the mother and newborn; It is important to take the necessary precautions against this hemodynamic deterioration. Perfusion index (PI) and pleth variability index (PVI) are parameters that can be measured noninvasively by pulseoximetry. In our study; By examining the lower extremity PI and PVI values in patients who will undergo elective cesareansection with SA; We investigated the usability and superiority of these values over each other in predicting hemodynamic deterioration.
METHODS: This research; It was conducted as a prospective observational study and 113 pregnant women aged 18-40 years who were ASA1-2 who were going to undergo lower segment cesarean section were included in our study. Demographic data of the patients (age, gender, weight, height, BMI) and routine hemogram values (hemoglobin, hematocrit, platelet, wbc) taken for preoperative evaluation were recorded. After the patients were placed on the operating table, PI and PVI values in the supine and sitting positions, PI and PVI values at the 1st, 2nd, 3rd, and 4th minutes after spinal anesthesia was applied to the patient, and finally, the postpartum PI, PVI values were recorded. In addition, in order to follow up the hemodynamic changes in all patients in thes tudy, Standard monitoring including electrocardiography, non-invasive blood pressure measurements and pulse measurement was performed, and changes in systolic pressure, diastolic pressure and heart rate were recorded before and after spinal anesthesia.
In our study, in which we examined PI and PVI values in predicting hypotension due to spinal anesthesia in elective C/S operations, we have reached the following results.
Unlike other studies in the literature; In our study, in which we followed the PI and PVI values in the lower extremities together and examined the diagnostic superiority of these values to each other and the relationship between the hemogram and hematocrit values of the patients, we did not find a statistically significant difference in the increase in the lower extremity basal PI and PVI values in the patient groups with and without hypotension. We interpreted this situation as lower extremity basal PI and PVI values were not effective in predicting hypotension due to spinal anesthesia.
We observed that there was no change in PI and PVI values in 5 patients who were not included in the study in whom spinal anesthesia failed, and that there was an increase in successful procedures independent of the development of significant hemodynamic instability. As a result, our study supported previous studies that PI and PVI values could be used to evaluate the success of spinal block.
In addition, we found that hgb and hct values were significantly lower in the hypotension-developing group in our study, but we found that this did not cause a significant difference in basal PI and PVI values. We think that the surgical HGB limit should be reconsidered in patients who will undergo elective surgery, due to the increased risk of hypotension if the patients have low hemogram values, and we believe that it would be beneficial to conduct more comprehensive multicenter studies in both cases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypotension developing group | – | Device: perfusion index, pleth variable indexPregnant women who underwent elective C/S under spinal anesthesia with systolic arterial pressure below 90 mmHg or with hypotension symptoms such as dizziness, nausea and vomiting during the procedure. |
| group without hypotension | – | Device: perfusion index, pleth variable indexPregnant women who underwent elective cesarean section under spinal anesthesia whose systolic arterial pressure did not fall below 90 mmHg or did not have any symptoms of hypotension during the procedure. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Female patients aged 18-40 who will undergo elective cesarean section
Key inclusion criteria (3 listed)
- Pregnant women who will undergo elective cesarean section
- Patients with ASA 1-2
- Patients aged 18-40 years
Key exclusion criteria (9 listed)
- Emergency cases
- <18 or > 40 years old
- Gestational age <36 weeks
- BMI ≥40
- Cardiovascular disease
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 |
|---|---|---|
| perfusion index, pleth variable indexAlso: a latch will be attached to the patient's fingera clip will be attached to the patient's finger and the perfusion index and pvi will be measured | Device | group without hypotension, hypotension developing group |
Primary outcome
perfusion index (PI)
Time frame: perioperative
Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and 1 more measurement will be made after routine oxytocin. Its relationship with hemodynamic deterioration will be examined and compared between both groups.In basal values of PI and the rate of change of these values; There was no significant difference between the groups with and without hypotension.
pleth variability index (PVI)
Time frame: perioperative
Before and after spinal anesthesia, 4 measurements will be made until the baby is born, and 1 more measurement will be made after routine oxytocin. Its relationship with hemodynamic deterioration will be examined and compared between both groups.In basal values of PVI and the rate of change of these values; There was no significant difference between the groups with and without hypotension.
BMİ-weight,
Time frame: preoperratif value
There was no difference in BMI and weight values between patients who developed and did not develop hypotension after spinal anesthesia
hemoglobin
Time frame: preoperatif value
Hemoglobin (p=0.014) and hematocrit (p=0.012) values weres ignificantly lower in pregnant women who developed hypotension
APGAR
Time frame: the 1st minute APGAR-the 5th minute APGAR
The 1st minute APGAR (p=0.005= and 5th minute APGAR (p=0.014) scores were significantly lower in the babies of pregnant women who developed hypotension.
3 secondary outcomes
systolic blood pressure
Time frame: perioperative
diastolic blood pressure
Time frame: perioperative
pulse
Time frame: perioperative
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 19 Sep 2022.
- Background: PubMed 22528166Loubert C. Fluid and vasopressor management for Cesarean delivery under spinal anesthesia: continuing professional development. Can J Anaesth. 2012 Jun;59(6):604-19. doi: 10.1007/s12630-012-9705-9. Epub 2012 Apr 24. English, French.
- Background: PubMed 18946298Langesaeter E, Rosseland LA, Stubhaug A. Continuous invasive blood pressure and cardiac output monitoring during cesarean delivery: a randomized, double-blind comparison of low-dose versus high-dose spinal anesthesia with intravenous phenylephrine or placebo infusion. Anesthesiology. 2008 Nov;109(5):856-63. doi: 10.1097/ALN.0b013e31818a401f.
- Background: PubMed 18522935Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.
- Results publication: PubMed 20236098Tsuchiya M, Yamada T, Asada A. Pleth variability index predicts hypotension during anesthesia induction. Acta Anaesthesiol Scand. 2010 May;54(5):596-602. doi: 10.1111/j.1399-6576.2010.02225.x. Epub 2010 Mar 10.
- The Effects of Motion on the Performance of Pulse Oximeters in Volunteers (Revised publicationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. I am undecided about sharing individual participant data with other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effects of Anesthesia Spinal and Epidural in Pregnancy, run by Adiyaman 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 3 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 19 Sep 2022. 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?
perfusion index (PI) (time frame: perioperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05174260, which also lists 4 linked publications.
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 19 Sep 2022.