Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654687
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Transthoracic Echocardiographic Monitoring of Cardiac Output Effects of Colloid Preload and Crystalloid Coload During Cesarean Delivery Under Spinal Anesthesia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Transthoracic Echocardiographic Monitoring of Cardiac Output Effects of Colloid Preload and Crystalloid Coload During Cesarean Delivery Under Spinal Anesthesia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Transthoracic echocardiography TTE has been introduced in anesthesia and intensive care practice to assess the volume status and predict fluid responsiveness with a few studies performed on pregnant women 5
In this study we aim to evaluate the effect of intravenous administration of albumin as a colloid preload on the maternal stroke volume SV and cardiac output CO versus crystalloid coload We used TTE to measure the changes in SV and CO at baseline and at subsequent time points after spinal anesthesia
In this study we aim to evaluate the effect of intravenous administration of albumin as a colloid preload on the maternal stroke volume SV and cardiac output CO versus crystalloid coload We used TTE to measure the changes in SV and CO at baseline and at subsequent time points after spinal anesthesia
Detailed Description:
This prospective randomized controlled double-blind study will be conducted at the obstetrics and gynecology operation room at Qassim University Medical City
Written informed consent will be obtained from eligible subjects on the day of the surgery The study subjects will be randomized using the R software version 352 R Core Team 2018 R Foundation for Statistical Computing Vienna Austria Subjects will randomly be assigned to 2 equal groups combined and crystalloid coload using the permuted block randomization method with randomly selected block sizes of 4 and 6 The group allocation codes will be hidden in sequentially numbered opaque sealed envelopes that will be opened only after assessing the eligibility and obtaining the consent from the subjects The study subjects and the outcome assessors will be blinded to the study group
Spinal anesthesia will be conducted will be assessed respectively by an anesthesiologist not involved in the study
All transthoracic cardiography images will be obtained by the second investigator who have the experience of accomplishing 500 cases before starting the study using the technique and guidelines reported in American Society of Echocardiography During obtaining the images intraoperatively the investigator will be separated from the surgical field by a sterile drape and the ultrasound probe will be covered with a sterile cover
The study subjects will enter the operating room lying supine on the operating table with slight left lateral position by tilting the operating table to the left Standard monitors will be attached to all patients noninvasive blood pressure pulse oximeter and electrocardiography Basal systolic blood pressure and heart rate will be recorded after a period of rest the average of 3 readings 2 minutes apart will be recorded Basal transthoracic cardiography images will be obtained
Two 18-gauge intravenous cannula will be inserted in two large veins of the right forearm one for IV fluids and the other for phenylephrine infusion In the combination group patients will receive 250 mL of human albumin 5 Human Albumin 50 gmL BAXTER Austria immediately before induction of spinal anesthesia SA over 10 minutes using an infusion pump Fresenius Kabi Agilia Volumat MC Infusion Pump Germany and 750 mL of Ringers lactate solution to be started during the intrathecal injection of the local anesthetic and infused over 15 minutes In the crystalloid coload group patients will receive 1000 mL of Ringers lactate solution to be started during the intrathecal injection of the local anesthetic and infused over 15 minutes In both groups phenylephrine infusion will be given prophylactically and will be started during the intrathecal injection of the local anesthetic at a dose ranging from 50-100 mcgminute to maintain the SBP within 20 of the basal readings After administering the study solutions Ringers lactate will be attached to the IV cannula and will be administered at a rate of 1 mLmin no other fluids will be administered until clamping of the umbilical cord end of the study period
In the sitting position spinal anesthesia will be conducted by intrathecal injection of hyperbaric bupivacaine 125 mg 05 and fentanyl 15 microgram using 27-gauge pencil point spinal needle at L3-L4 intervertebral space
Surgery will be started after reaching at least an upper sensory level of T4 below this level spinal anesthesia will be considered failed and patients will be excluded from the study
SV and CO will be measured at 5 time points basal readings 1 minute after SA 5 minutes after SA immediately after delivery of the baby and clamping the cord and 1 hour after the end of the study SBP and HR will be recorded ever minute till the delivery of the baby then every 3 minutes till the end of the surgery
Written informed consent will be obtained from eligible subjects on the day of the surgery The study subjects will be randomized using the R software version 352 R Core Team 2018 R Foundation for Statistical Computing Vienna Austria Subjects will randomly be assigned to 2 equal groups combined and crystalloid coload using the permuted block randomization method with randomly selected block sizes of 4 and 6 The group allocation codes will be hidden in sequentially numbered opaque sealed envelopes that will be opened only after assessing the eligibility and obtaining the consent from the subjects The study subjects and the outcome assessors will be blinded to the study group
Spinal anesthesia will be conducted will be assessed respectively by an anesthesiologist not involved in the study
All transthoracic cardiography images will be obtained by the second investigator who have the experience of accomplishing 500 cases before starting the study using the technique and guidelines reported in American Society of Echocardiography During obtaining the images intraoperatively the investigator will be separated from the surgical field by a sterile drape and the ultrasound probe will be covered with a sterile cover
The study subjects will enter the operating room lying supine on the operating table with slight left lateral position by tilting the operating table to the left Standard monitors will be attached to all patients noninvasive blood pressure pulse oximeter and electrocardiography Basal systolic blood pressure and heart rate will be recorded after a period of rest the average of 3 readings 2 minutes apart will be recorded Basal transthoracic cardiography images will be obtained
Two 18-gauge intravenous cannula will be inserted in two large veins of the right forearm one for IV fluids and the other for phenylephrine infusion In the combination group patients will receive 250 mL of human albumin 5 Human Albumin 50 gmL BAXTER Austria immediately before induction of spinal anesthesia SA over 10 minutes using an infusion pump Fresenius Kabi Agilia Volumat MC Infusion Pump Germany and 750 mL of Ringers lactate solution to be started during the intrathecal injection of the local anesthetic and infused over 15 minutes In the crystalloid coload group patients will receive 1000 mL of Ringers lactate solution to be started during the intrathecal injection of the local anesthetic and infused over 15 minutes In both groups phenylephrine infusion will be given prophylactically and will be started during the intrathecal injection of the local anesthetic at a dose ranging from 50-100 mcgminute to maintain the SBP within 20 of the basal readings After administering the study solutions Ringers lactate will be attached to the IV cannula and will be administered at a rate of 1 mLmin no other fluids will be administered until clamping of the umbilical cord end of the study period
In the sitting position spinal anesthesia will be conducted by intrathecal injection of hyperbaric bupivacaine 125 mg 05 and fentanyl 15 microgram using 27-gauge pencil point spinal needle at L3-L4 intervertebral space
Surgery will be started after reaching at least an upper sensory level of T4 below this level spinal anesthesia will be considered failed and patients will be excluded from the study
SV and CO will be measured at 5 time points basal readings 1 minute after SA 5 minutes after SA immediately after delivery of the baby and clamping the cord and 1 hour after the end of the study SBP and HR will be recorded ever minute till the delivery of the baby then every 3 minutes till the end of the surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None