Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

Overview

Pregnant women with a positive preoperative Supine stress test were found to be a subgroup at increased risk of symptomatic hypotension after spinal anesthesia

Full Title of Study: “A Study Evaluating Hypotension and Autonomic Nervous System Dysfunction During Spinal Anesthesia for Cesarean Section and Its Relation to the Effect of Prophylaxis Phenylephrine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: May 2017

Detailed Description

Patients will be placed in dorsal decubitus dislocating the uterus to the left for a few minutes, with blood pressure and heart rate recorded three times, with a three-minute interval between measurements to obtain mean baseline levels and this will be repeated in an upright position to record the same measurement.Orthostatic hypotension (Orthostatic hypotension "OH" is defined specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic blood pressure within 3 minutes of standing.

Interventions

  • Drug: Phenylephrine
    • it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section
  • Other: Placebo
    • 5 ml normal saline will be given before spinal anesthesia

Arms, Groups and Cohorts

  • Placebo Comparator: Group A
    • This group will include patients with orthostatic hypotension and will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension
  • Active Comparator: Group B
    • This group will include patients with orthostatic hypotension and will be managed with prophylaxis single dose of phenylephrine, 50 ug IV, will be administered immediately before the spinal block then the patients will be managed with routine spinal anesthesia Ephedrine will be used for management of intraoperative hypotension

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of hypotension
    • Time Frame: within first 24 hours after spinal anesthesia
    • blood pressure will be measured every 3 minutes within the first 30 minutes after spinal block the every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block

Secondary Measures

  • Frequency of bradycardia
    • Time Frame: within first 24 hours after spinal anesthesia
    • heart rate will be measured every 5 minutes till the end of the caesarian section. postoperatively will be checked every 15 minutes in the first hour the every 30 minutes till the recovery from spinal block
  • Ephedrine usage
    • Time Frame: within first 24 hours after spinal anesthesia
    • Total amount of ephedrine given
  • intraoperative fluid management
    • Time Frame: within first 24 hours after spinal anesthesia
    • Total amount of fluid given
  • Apgar scores
    • Time Frame: within first 24 hours after spinal anesthesia
    • Apgar scores in the first and fifth minutes of the newborns

Participating in This Clinical Trial

Inclusion Criteria

Physical status ASA I, A full term pregnancy A single fetus Elective cesarean section.

Exclusion Criteria

Refusal of the patient to participate in the study History of hypertension Pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities History of hypersensitivity to the drugs used Contraindications to spinal block.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sayed Kaoud Abd-Elshafy, Associate profossor of anesthesia – Assiut University
  • Overall Official(s)
    • Sayed K Abd-Elshafy, MD, Principal Investigator, Associate professor of anesthesia

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