Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension

Adverse Anesthesia Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015857
• Other study ID #: cesarean sections
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2016
• Last updated: May 1, 2017
• Start date: January 2017
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• full term singleton parturients

• elective cesarean sections

Exclusion Criteria:

• cardiac morbidities

• hypertensive disorders of pregnancy

• peripartum bleeding

• body mass index > 35 will be excluded from the study

Related Conditions & MeSH terms

• Adverse Anesthesia Outcome
• Hypotension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)		2 hours
Secondary	systolic and diastolic blood pressures measured in mm Hg		2 hours
Secondary	heart rate measured in beats per minute		2 hours
Secondary	nausea and vomiting measured in number of attacks		2 hours