NCT03163914

Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Cukurova University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Spinal Anesthesia

Interventions

Type	Name	Description
DRUG	Epinephrine	Epinephrine infusion rate will adjust 30 ml/h (5µg/ ml )
DRUG	Norepinephrine	Norepinephrine infusion rate will adjust 30 ml/h (5µg/ ml )
DRUG	Phenylephrine	Phenylephrine infusion rate will adjust 30 ml/h (100µg/ ml )
DRUG	Saline	saline infusion will apply till the end of the surgery

Timeline

• Start date: 2017-07-19
• Primary completion: 2018-04-24
• Completion: 2018-04-24
• First posted: 2017-05-23
• Last updated: 2019-10-24

Locations

1 site across 1 country: Turkey (Türkiye)