Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension
- Conditions
- Spinal Anesthesia
- Interventions
- Registration Number
- NCT03163914
- Lead Sponsor
- Cukurova University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 160
- ASA I-II physical status
- Pregnant patients
- Full term pregnant
- ASA III-IV physical status
- Emergency status
- Heart disease
- Hypertension
- Body mass index>25
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Saline Saline infusion will apply at equivalent volume till the surgical operation Epinephrine Epinephrine Epinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h. Norepinephrine Norepinephrine Norepinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h. Phenylephrine Phenylephrine Phenylephrine will prepare as 100 µg/ ml and phenylephrine infusion rate will adjust 30 ml/h.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Çukurova University Balcalı Hospital
🇹🇷Adana, Turkey