Intramuscular Phenylephrine HCL for Prevention of Spinal Anesthesia Induced Hypotension

• Status: Completed
• Trial end date: 2020-07-31
• Target enrollment: 0
• Participant gender: Female

Summary

Background: Spinal anesthesia (SA) is preferred over general anesthesia in Cesarean section (CS) due to its better safety profile but SA induced hypotension remains a big challenge for the clinical Anesthetist. Different methods including 15° left lateral table tilt, leftward uterine manual displacement, fluid pre-and co-loading have been used but drop in Systolic Blood Pressure (SBP) jeopardizing maternal and fetal well-being still occurs. Timely administered Phenylephrine HCL, an α-1 adrenergic agonist, is a recommended remedy.

Subjects and methods: Sixty parturients of American Society of Anaesthesiologists (ASA) physical status 1 and 2, scheduled for elective CS under SA were enrolled in this prospective double-blinded study and randomly divided into two equal groups, P4 and P8. They received intramuscular (IM) Phenylephrine HCL 04 mg and 08 mg respectively before SA. Spinal block up to T6 was achieved with 12.5 mg 0.5% Bupivacaine HCl heavy. The incidence and intensity of hypotension, rescue doses of Phenylephrine HCL and any adverse event, were recorded. Data collected was analyzed using Epi lnfo ™ version 7.2.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rehman Medical Institute - RMI
• Treatments: Oxymetazoline; Phenylephrine; Synephrine

Criteria

Inclusion Criteria:

• All pregnant ladies of American Society of Anesthesiologists (ASA) physical status 1 or 2 with

• Singleton Pregnancy,

• Full term pregnancy, and

• Admitted for elective CS

Exclusion Criteria:

All those participants having;

• Blood pressure ≥140/90 mm of Hg,

• ASA 3 or above status,

• Contraindication to spinal anesthesia

• Fetal anomalies/

• Abnormal placentae

• Refusal to consent