Anesthetic Complication Spinal
Conditions
Keywords
spinal, cesarean delivery, phenylephrine, hypotension
Brief summary
Rapid administration of crystalloid immediately after induction of spinal anesthesia (coload) to be more effective in terms of managing hypotension as compared to administering crystalloid before spinal anesthesia (preload). Phenylehrine infusion is a safe and effective way to reduce incidence and frequency of hypotension during SA for cesarean delivery. Hypotension was virtually eliminated by use of high-dose prophylactic phenylephrine infusion at a rate of 100 µg/min and rapid crystalloid coload up to two liters (administration at the time of SA). However, incidence of reactive hypertension was frequent up to 47% with decrease in maternal heart rate (HR). This may raise concern in patients in whom increase of blood pressure may be detrimental, like chronic hypertension and in the presence of a compromised uteroplacental blood flow. A recent study found that infusing phenylephrine at a fixed rate of 75 and 100 ug/min is associated with more episodes of hypertension than placebo or the lower infusion rates of 25 and 50 ug/min respectively. However, there was no reduction in the number of physician interventions (phenylephrine boluses and stopping the infusion) needed to maintain maternal systolic blood pressure within 20% of baseline among all groups. Prophylactic fixed rate infusions may have limited application in clinical practice, and a variable rate (i.e. modifying the rate according to hemodynamics) has been advocated. The bolus administration of phenylephrine to treat hypotension is still commonly used, but requests multiple interventions from the anesthesiologists and is time consuming. Eighty patients scheduled for cesarean delivery under spinal anesthesia will be assigned to one of two groups. Immediately after spinal injection, rapid crystalloid colaod of lactated Ringer of 15 mL/kg over a period of 10-15 min will be initiated. Patients in Group I will receive infusion of normal saline (placebo) and patients in group II variable infusion rate of phenylephrine started at 0.75 ug/kg (close to the dose of 50 ug/min recommended for fixed infusion rate). The number of interventions needed to maintain maternal systolic blood pressure within 20% of baseline, hemodynamic performance, intraoperative nausea and vomiting, and umbilical cord blood gases will be compared between the two groups. We will define a reliable and safe method to ensure maternal hemodynamic stability during spinal anesthesia for cesarean delivery with the least physician interference.
Interventions
DRUGPhenylephrine
Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline
DRUGsaline
Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Parturients beyond 37 weeks gestation * ASA І or ІІ
Exclusion criteria
* pregnancy-induced hypertension * chronic hypertension * multiple pregnancy * fetal compromise * diabetes mellitus * polyhydramnios * body weight \>100 kg * major systemic disease * anemia (hemoglobin concentration\<10 g/dl) * clotting diathesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery. | Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours). | Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following: * stopping the phenylephrine infusion * changing the rate of phenylephrine infusion * rescue intravenous bolus of phenylephrine (100 µg) for hypotension * rescue intravenous bolus of atropine (0.4 mg) for bradycardia |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saline Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline | 39 |
| Phenylephrine PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery | 40 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Saline | Phenylephrine | Total |
|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 5 | 32.5 years STANDARD_DEVIATION 5 | 33 years STANDARD_DEVIATION 5 |
| Sex/Gender, Customized Number of Female Participants | 39 participants | 40 participants | 79 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 39 | 0 / 40 |
| serious Total, serious adverse events | 0 / 39 | 0 / 40 |
Outcome results
Primary
Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery.
Physician interventions are triggered by hemodynamic changes more than 20% of baseline. The intervention can be one or more of the following: * stopping the phenylephrine infusion * changing the rate of phenylephrine infusion * rescue intravenous bolus of phenylephrine (100 µg) for hypotension * rescue intravenous bolus of atropine (0.4 mg) for bradycardia
Time frame: Patients will be followed up throughout the Cesarean delivery (average of 1.5 hours).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phenylephrine | Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery. | 0 number of interventions |
| Saline | Number of Physician Interventions Needed to Maintain Maternal Blood Pressure After Spinal Anesthesia Within 20% of Baseline and to Treat Bradycardia During Cesarean Delivery. | 3 number of interventions |