An interventional study of Transthoracic Echocardiography and Ringer lactate 1000 ml in Pregnancy, Cesarean Delivery and Spinal Anesthesia Induced Hypotension, sponsored by Sameh Fathy. Completed at 1 site in Egypt. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Sameh Fathy · Not applicable, Interventional, and Prevention
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.
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 3.5.2 (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 gm/L, 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 Ringer's 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 Ringer's 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 25-50 mcg/minute to maintain the SBP within 20 % of the basal readings. After administering the study solutions, Ringer's lactate will be attached to the IV cannula and will be administered at a rate of 1 mL/min; 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 12.5 mg 0.5% 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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 162 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →Sameh Fathy is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output. Patients will receive 1000 mL of Ringer's lactate solution over 15 minutes.
Device: Transthoracic Echocardiography · Drug: Ringer lactate 1000 ml
Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output. Patients will receive 250 mL of human albumin 5% over 10 minutes and 750 mL of Ringer's lactate solution over 15 minutes.
Device: Transthoracic Echocardiography · Drug: Albumin · Drug: Ringer lactate 750 ml
Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output.
Patients will receive 1000 mL of Ringer's lactate solution over 15 minutes.
Patients will receive 250 mL of human albumin 5% over 10 minutes
Patients will receive 750 mL of Ringer's lactate solution over 15 minutes.
Changes in Cardiac Output
The changes in Cardiac Output are measured relative to baseline immediately after delivery
Time frame: Immediately after delivery of baby
Changes in stroke volume
The changes in stroke volume are measured compared to the baseline immediately after delivery
Time frame: Immediately after delivery of baby
Total phenylephrine dose (mg)
Time frame: Until delivery of baby
Total ephedrine dose (mg)
Time frame: Until delivery of the baby
Total glycopyrrolate dose (mg)
Time frame: Until delivery of the baby
Incidence of hypotension
Decrease in SBP \> 20% of the basal reading
Time frame: Until end of surgery
Incidence of bradycardia
Heart rate \< 50 beats/minute
Time frame: Until end of surgery
Incidence of nausea and/or vomiting
Time frame: Until end of surgery
Measurement of APGAR score
APGAR score includes appearance, pulse, grimace, activity and respiration
Time frame: 1 minute and 5 minutes after delivery of the baby
Measurement of Urine output (ml)
Time frame: 1 hour after delivery of the baby
Plan to share: Undecided
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Sameh Fathy