NCT03015857

Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension

A Comparison Between Phenylephrine and Norepinephrine Boluses in Prevention of Post-spinal Hypotension During Cesarean Delivery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Kasr El Aini Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.

Detailed description

On arrival to the operating room, an 18g cannula will be inserted and monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5 interspace using 25 g spinal needle in the sitting position. After spinal block, patients will be randomly allocated into one of two groups: * Phenylephrine group (n=100) * Norepinephrine group (n=100) Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or if the heart rate was below 55 bpm. Patients will be positioned in the supine position with left lateral tilt. Block success will be assessed using pinprick, patients with failed block will be excluded from the study. The highest sensory block level will be assessed after 5 minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5 litres.

Conditions

• Adverse Anesthesia Outcome

Interventions

Type	Name	Description
DRUG	phenylephrine	\- phenylephrine; a vasopressor drug given to prevent post spinal hypotension
DRUG	Norepinephrine	\- norepinephrine; a vasopressor drug given to prevent post spinal hypotension
DRUG	Bupivacaine	intrathecal bupivacaine 10 mg will be given in both groups
DRUG	Fentanyl	intrathecal fentanyl 20 mcg will be given in both groups
DRUG	Placebo (normal saline)

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-03-01
• Completion: 2017-04-01
• First posted: 2017-01-10
• Last updated: 2017-05-03