Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

Phase 2

Completed

• Conditions: Anesthesia, Spinal; Anesthesia, Obstetrical
• Interventions: Other: Placebo; Drug: Phenylephrine

• Registration Number: NCT02958215
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 980

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Placebo	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
Group B	Phenylephrine	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

Primary Outcome Measures

Name	Time	Method
Incidence of hypotension	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 Outcome Measures

Name	Time	Method
Ephedrine usage	within first 24 hours after spinal anesthesia	Total amount of ephedrine given
Apgar scores	within first 24 hours after spinal anesthesia	Apgar scores in the first and fifth minutes of the newborns
Frequency of bradycardia	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
intraoperative fluid management	within first 24 hours after spinal anesthesia	Total amount of fluid given

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt