Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section

Anesthesia, Spinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958215
• Other study ID #: IRB0000871230
• Status: Completed
• Phase: Phase 2
• First received: November 4, 2016
• Last updated: May 16, 2017
• Start date: June 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Obstetrical
• Anesthesia, Spinal
• Hypotension

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypotension	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	within first 24 hours after spinal anesthesia
Secondary	Frequency of bradycardia	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	within first 24 hours after spinal anesthesia
Secondary	Ephedrine usage	Total amount of ephedrine given	within first 24 hours after spinal anesthesia
Secondary	intraoperative fluid management	Total amount of fluid given	within first 24 hours after spinal anesthesia
Secondary	Apgar scores	Apgar scores in the first and fifth minutes of the newborns	within first 24 hours after spinal anesthesia