Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

Study Overview
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Brief Summary
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Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia

Detailed Description
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Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension OH is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.

Official Title
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A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction During Spinal Anesthesia for Cesarean Section and Its Relation to the Effect of Prophylaxis Phenylephrine

Conditions
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Anesthesia, Obstetrical, Anesthesia, Spinal

Intervention / Treatment
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* Drug: Phenylephrine
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section. Exclusion Criteria: Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A<br>This group will include patients with orthostatic hypotension and will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension | Other: Placebo<br>* 5 ml normal saline will be given before spinal anesthesia<br>|
| Active Comparator: Group B<br>This group will include patients with orthostatic hypotension and will be managed with prophylaxis single dose of phenylephrine, 50 ug IV, will be administered immediately before the spinal block then the patients will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension | Drug: Phenylephrine<br>* it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypotension | blood pressure will be measured every 3 minutes within the first 30 minutes after spinal block the every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block | within first 24 hours after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of bradycardia | heart rate will be measured every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block | within first 24 hours after spinal anesthesia | 
| Ephedrine usage | Total amount of ephedrine given | within first 24 hours after spinal anesthesia | 
| intraoperative fluid management | Total amount of fluid given | within first 24 hours after spinal anesthesia | 
| Apgar scores | Apgar scores in the first and fifth minutes of the newborns | within first 24 hours after spinal anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnant, Orthostatic, Cesarean section, Phenyephrine, Hypotension