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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epinephrine | Active Comparator | Epinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h. |
|
| Norepinephrine | Active Comparator | Norepinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h. |
|
| Phenylephrine | Active Comparator | Phenylephrine will prepare as 100 µg/ ml and phenylephrine infusion rate will adjust 30 ml/h. |
|
| Control | Placebo Comparator | Saline infusion will apply at equivalent volume till the surgical operation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epinephrine | Drug | Epinephrine infusion rate will adjust 30 ml/h (5µg/ ml ) |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
pregnant patients
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| Name | Affiliation | Role |
|---|---|---|
| Hakkı Ünlügenç | Cukurova University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Çukurova University Balcalı Hospital | Adana | 01380 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| D009638 | Norepinephrine |
| D010656 | Phenylephrine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Partipicants and care providers will not known which medication will apply.
| Norepinephrine | Drug | Norepinephrine infusion rate will adjust 30 ml/h (5µg/ ml ) |
|
|
| Phenylephrine | Drug | Phenylephrine infusion rate will adjust 30 ml/h (100µg/ ml ) |
|
|
| Saline | Drug | saline infusion will apply till the end of the surgery |
|
|
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |