Ultrasound Guided Fluid Loading Before Spinal Anesthesia
- Conditions
- Cesarean Section ComplicationsSpinal AnesthesiaHypotensionHypovolemiaSympathetic BlockadeFluid Loading
- Interventions
- Drug: T
- Registration Number
- NCT07108881
- Lead Sponsor
- University Tunis El Manar
- Brief Summary
Perioperative hypotension is a common complication of spinal anesthesia during cesarean sections.
The aim of this study was to evaluate the effectiveness of echoguided correction of hypovolemia through crystalloid preloading on the incidence of arterial hypotension during scheduled cesarean sections under spinal anesthesia.
It was a double-blind, randomized controlled trial study conducted on hypovolemic parturients, scheduled for cesarean section. investigators compared ultrasound guided correction of hypovolemia to a standard care protocol without preloading.
Hypovolemia was defined as a ≥12% increase in the variation of the velocity-time integral of subaortic blood flow during a passive leg raising test.
Preloading was guided by the variation of the velocity-time integral of subaortic blood flow during volume expansion tests.
- Detailed Description
In the literature, numerous studies have compared the different pre-filling and co-filling protocols with different solutes. The majority of them conclude that co-filling is superior to pre-filling when the same type of solute is used. Pre-filling with crystalloids was then abandoned in favor of co-filling with crystalloids It is essential to remember that several invasive or non-invasive means of hemodynamic monitoring have previously been validated in pregnant women The use of invasive tools for assessing blood volume, particularly arterial and central venous catheters, is limited given the brevity of obstetric procedures, the risk of morbidity in awake patients and their high costs. Although non-invasive methods are preferable, some remain imperfect, notably carotid Doppler and bioimpedance devices Transthoracic echocardiography stands out as a particularly reliable and relevant non-invasive tool for assessing cardiac output and blood volume in parturients It allows analysis of the variation of the subaortic velocity time integral (∆ ITV s-a) during the passive leg raise test (LET). It is the only dynamic preload parameter validated in patients during spontaneous ventilation, thus allowing assessment of blood volume.
After reviewing the literature, the investigators found no studies about, exclusively hypovolemic patients, the effect of combining pre-filling with co-filling with crystalloids, monitored by echocardiographic preload-dependence indices, on the incidence of arterial hypotension during elective cesarean sections performed under spinal anesthesia.
In this study, monitoring was performed by transthoracic echocardiography, based on the variation in subaortic TVI following the passive leg raise test and vascular fluid tests.
The objective of this prospective randomized study was to evaluate the efficacy of ultrasound-guided correction of hypovolemia by pre-filling with crystalloids on the incidence of arterial hypotension during elective cesarean sections performed under spinal anesthesia.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 116
ASA II score, singleton pregnancy cesarean section
Spinal anesthesia failure general anesthesia postpartum hemorhage saline solution volume > 1000 ml for preloading echocardiography: difficulties Poor echogenicity
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group C C hypovolemic parturient receiving cardiac -ultrasound -VTI guided cristalloid preloading with 1 to 4 fluid challenges of 250 ml each until they reach a normal volemic state before receiving spinal anesthesia groupT T hypovolemic parturient reiving the standard care ie; they dont receive any preloading but coloading with critalloids with rescue boluses of ephedrine if hypotension happens
- Primary Outcome Measures
Name Time Method incidence of post-spinal anesthesia arterial hypotension during surgery 60 minutes The incidence of intraoperative post-spinal hypotension Defined by a drop in blood pressure (BP) of more than 20% of its reference value, or a blood pressure (BP) \< 100 mmHg
- Secondary Outcome Measures
Name Time Method Time to onset of the first episode of arterial hypotension (min) 60 minutes hypotension is Defined by a drop in SBP of more than 20% of its reference value, or a SBP \< 100mmHg
Duration of hypotensive episode (min) 60 minutes the duration of hypotension from the onset of the first episode until reaching normal ranges again
Depth of hypotension (% fall from baseline value) 60 minutes hypotension is Defined by a drop in SBP of more than 20% of its baseline value, or a SBP \< 100mmHg
Consumption of per-op vasopressors (mg of ephedrine) 60 minutes total dose of ephedrine given in case of hypotension
Fetal pH at the umbilical cord at birth. 30 minutes right after delivery
Newborn APGAR score at the first and fifth minute 30 minutes at birth
Variation in intraoperative cardiac output (% drop from baseline) 60 minutes cardiac output is expected to rise of fall from its baseline and is caculated in percenttages of variation from its baseline
Volume of cristalloids and colloids infused (ml) 60 minutes total volume of critalloids given either when preloading bfeore spinal anesthesia or while coloading after spinal anesthesia
Incidence of maternal bradycardia (%) - 60 minutes (Heart Rate \< 50 bpm)
Incidence of intraoperative nausea and vomiting (%) 60 minutess nausea and vomiting usually at the moments of severe hypotension
Trial Locations
- Locations (1)
Tunis maternity and neonatology center, minisetry of public health
🇹🇳Tunis, Tunisia
Tunis maternity and neonatology center, minisetry of public health🇹🇳Tunis, Tunisia