Spinal Anesthesia
Conditions
Keywords
vasopressor, spinal anaesthesia
Brief summary
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
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.
Interventions
DRUGEpinephrine
Epinephrine infusion rate will adjust 30 ml/h (5µg/ ml )
DRUGNorepinephrine
Norepinephrine infusion rate will adjust 30 ml/h (5µg/ ml )
DRUGPhenylephrine
Phenylephrine infusion rate will adjust 30 ml/h (100µg/ ml )
DRUGSaline
saline infusion will apply till the end of the surgery
Sponsors
Cukurova University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
Partipicants and care providers will not known which medication will apply.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of intraoperative maternal hypotension | At the time from start of vasopressor infusion till the end of surgery. The time frame is approximately 1 hour, peroperatively. | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed