Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension

Study Overview
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Brief Summary
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160 pregnant patients will be enrolled in this study. Participants will divide in to 4 groups. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all patients. After performed spinal anaesthesia, vasopressor infusion will be started intravenously. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE and 0.9% saline (group S) was launched immediately after induction of spinal anesthesia. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV). If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.

Detailed Description
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After approved informed consent, 160 pregnant (term) patients with American society of anaesthesiologist (ASA) physiological status I-II will include this prospective, randomized clinical study. For randomisation of participants, computerized randomisation programme will use and they will divide into 4 groups. Basal value of systolic blood pressure(SBP) and heart rate (HR) will calculate with mean of the measure of 3 time SBP and HR before spinal anaesthesia. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl at the point of lumbar 3-4 or 4-5 interspinous space to the all patients. After performed spinal anaesthesia, vasopressor infusion will start intravenously. Epinephrine, norepinephrine and phenylephrine will use for vasopressor infusion. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. salin infusion will launch 30 ml/h for group Salin. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV) for rescue drug. If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV. At the end of the study all collected data will use for statistically analysis.

Official Title
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Comparison of the Effect of Epinephrine, Norepinephrine and Phenylephrine on Spinal Anesthesia Induced Hypotension

Conditions
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Spinal Anesthesia

Intervention / Treatment
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* Drug: Epinephrine
* Drug: Norepinephrine
* Drug: Phenylephrine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-II physical status Pregnant patients Full term pregnant Exclusion Criteria: ASA III-IV physical status Emergency status Heart disease Hypertension Body mass index>25

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epinephrine<br>Epinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h. | Drug: Epinephrine<br>* Epinephrine infusion rate will adjust 30 ml/h (5µg/ ml )<br>* Other names: group I;|
| Active Comparator: Norepinephrine<br>Norepinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h. | Drug: Norepinephrine<br>* Norepinephrine infusion rate will adjust 30 ml/h (5µg/ ml )<br>* Other names: group II;|
| Active Comparator: Phenylephrine<br>Phenylephrine will prepare as 100 µg/ ml and phenylephrine infusion rate will adjust 30 ml/h. | Drug: Phenylephrine<br>* Phenylephrine infusion rate will adjust 30 ml/h (100µg/ ml )<br>* Other names: group III;|
| Placebo Comparator: Control<br>Saline infusion will apply at equivalent volume till the surgical operation | Drug: Saline<br>* saline infusion will apply till the end of the surgery<br>* Other names: group IV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative maternal hypotension | The incidence of hypotension (described as less than 80% of baseline (prenatal) SBP or SBP <90 mm Hg), the total number of hypotension episodes during surgery | At the time from start of vasopressor infusion till the end of surgery. The time frame is approximately 1 hour, peroperatively. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vasopressor, spinal anaesthesia