Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427382
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2024-05-19
Brief Title:
Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Prediction of Hypotension Using Perfusion Index Following Spinal Anesthesia
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is aimed to investigate whether the perfusion index PI can predict hypotension after spinal anesthesia in elderly patients as much as in non-elderly patients
Detailed Description:
In orthopedic lower extremity surgeries spinal anesthesia is a preferred method of anesthesia compared to general anesthesia Spinal anesthesia may cause severe hypotension and adverse effects in the patient due to pharmacologic sympathectomy Especially elderly patients and patients with comorbid diseases are at risk Hypoperfusion and vasopressor drugs to be used in treatment may lead to adverse effects
Perfusion index is calculated as the ratio non-pulsatile to pulsatile flow in peripheral capillary blood flow Perfusion index is a non-invasive method that provides insight into the dynamics of vascular tone using pulse oximetry It can be used to evaluate perfusion dynamics due to changes in peripheral vascular tone and to detect the possibility of developing hypotension following spinal anesthesia There is insufficient data to assess whether PI is a marker of hypotension after spinal anesthesia in older patients compared to non-elderly patients The planned study aims to investigate whether PI predicts hypotension after spinal anesthesia in older patients as well as non-elderly patients
Preoperative demographic data of the patients preoperative heart rate noninvasive systolic and diastolic blood pressures mean arterial pressures and peripheral oxygen saturations will be measured and noted For the initial perfusion index PI value PI measurements will be taken 3 times at a few minute intervals with a noninvasive probe attached to the finger and the average will be recorded as the initial PI value Spinal anesthesia will be applied by injecting an appropriate dose of 05 hyperbaric bupivacaine intrathecally depending on the patient is structure and the type of surgery to ensure adequate sensory and motor blockade The patient will be immediately placed in the supine position After the appropriate period the level of sensory blockade will be evaluated Heart rate noninvasive systolic and diastolic blood pressures mean arterial pressure peripheral oxygen saturation and perfusion index will be recorded Hypotension after spinal anesthesia will be defined as systolic blood pressure less than 90 mmHg systolic blood pressure decrease by more than 25 from the preoperative baseline value or average blood pressure less than 60 mmHg Patients under the age of 65 or over the age of 65 who will undergo lower extremity surgery under spinal anesthesia will be evaluated in two groups It will be examined whether there are differences between the groups in terms of demographic data age gender comorbidity etc and perfusion index
The studyamp39s primary outcome is to investigate whether PI values have a predictive value in predicting post-spinal hypotension between the two groups and if so whether there is a statistically significant difference
The secondary outcome is to evaluate whether the perfusion index can be used to predict spine-induced hypotension in orthopedic lower extremity surgery
Perfusion index is calculated as the ratio non-pulsatile to pulsatile flow in peripheral capillary blood flow Perfusion index is a non-invasive method that provides insight into the dynamics of vascular tone using pulse oximetry It can be used to evaluate perfusion dynamics due to changes in peripheral vascular tone and to detect the possibility of developing hypotension following spinal anesthesia There is insufficient data to assess whether PI is a marker of hypotension after spinal anesthesia in older patients compared to non-elderly patients The planned study aims to investigate whether PI predicts hypotension after spinal anesthesia in older patients as well as non-elderly patients
Preoperative demographic data of the patients preoperative heart rate noninvasive systolic and diastolic blood pressures mean arterial pressures and peripheral oxygen saturations will be measured and noted For the initial perfusion index PI value PI measurements will be taken 3 times at a few minute intervals with a noninvasive probe attached to the finger and the average will be recorded as the initial PI value Spinal anesthesia will be applied by injecting an appropriate dose of 05 hyperbaric bupivacaine intrathecally depending on the patient is structure and the type of surgery to ensure adequate sensory and motor blockade The patient will be immediately placed in the supine position After the appropriate period the level of sensory blockade will be evaluated Heart rate noninvasive systolic and diastolic blood pressures mean arterial pressure peripheral oxygen saturation and perfusion index will be recorded Hypotension after spinal anesthesia will be defined as systolic blood pressure less than 90 mmHg systolic blood pressure decrease by more than 25 from the preoperative baseline value or average blood pressure less than 60 mmHg Patients under the age of 65 or over the age of 65 who will undergo lower extremity surgery under spinal anesthesia will be evaluated in two groups It will be examined whether there are differences between the groups in terms of demographic data age gender comorbidity etc and perfusion index
The studyamp39s primary outcome is to investigate whether PI values have a predictive value in predicting post-spinal hypotension between the two groups and if so whether there is a statistically significant difference
The secondary outcome is to evaluate whether the perfusion index can be used to predict spine-induced hypotension in orthopedic lower extremity surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None