Ignite Creation Date:
2024-07-17 @ 11:10 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479512
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
Caval-aorta Index and Perfusion Index on Predict Hypotension After Spinal Anaesthesia in Elderly
Sponsor:
Ankara City Hospital Bilkent
Organization:
Ankara City Hospital Bilkent
Study Overview
Official Title:
Can Caval-aorta Index and Perfusion Index Predict Hypotension After Spinal Anaesthesia in Elderly Patients Undergoing Lower Extremity Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The aim of our study was to predict hypotension by using caval aorta index and perfusion index in elderly patients who may develop hypotension after spinal anesthesia
Detailed Description:
The study will include 190 patients over 60 years of age who are planned to undergo elective lower extremity surgery in the supine position with spinal anaesthesia This study is planned as a single-centre prospective observational study All patients planned to be included in the study will be fasted according to the standard protocol Age height body weight body mass index gender type of surgery systemic disease preoperative heart rate HR noninvasive systolic SBP diastolic blood pressure DBP mean arterial pressure MAP and peripheral oxygen saturation SpO₂ will be measured and noted in the waiting area before entering the operating room For the initial perfusion index PI value PI measurement will be taken 3 times at 5 minutes intervals with a probe to be attached to the same finger and the average will be recorded as the initial PI value To measure the IVC diameter the maximum internal AP diameter of the IVC will be measured 3 times in M-mode during expiration and the mean will be taken The maximum internal AP diameter of the abdominal aorta will be measured three times during systole and the mean will be recorded as the aortic diameterThe study will be explained to all patients participating in the study and informed consent will be obtained from the patientsRoutine preoperative preparations and monitoring of the patients admitted to the operating room will be performedSpinal anaesthesia will be performed through L3-4 or L4-5 intervertebral spaces in the sitting positionDepending on the nature of the patient and the type of surgery an appropriate dose of 05 hyperbaric bupivacaine will be injected intrathecally to provide adequate sensory blockThe patient will be immediately placed in the supine positionThe level of sensory blockade will be evaluated at the end of the appropriate time heart rate systolic diastolic blood pressure mean arterial pressure oxygen saturation and PI will be recorded every 2 minutes for the first 15 minutes then every 5 minutes until the 30th minute then every 10 minutes until the 60th minute and at the end of the operationHypotension after spinal anaesthesia will be defined as SDB less than 90 mmHg a fall in SDB by more than 30 from the preoperative baseline value or an OAB less than 60 mmHgPatients will be divided into two groups as patients with and without hypotension after spinal anaesthesia Demographic data age gender comorbidity etc caval-aorta index and PI will be analysed for differences between the groups
The primary aim of the study was to evaluate the ability of caval-aorta index and PI to predict post-spinal hypotension in elderly patients between the two groups
The primary aim of the study was to evaluate the ability of caval-aorta index and PI to predict post-spinal hypotension in elderly patients between the two groups
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