Back to resultsPhenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section
Primary Purpose
Anesthesia, Obstetrical, Anesthesia, Spinal
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Phenylephrine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Anesthesia, Obstetrical focused on measuring Orthostatic, Cesarean section, Pregnant, Phenyephrine, Hypotension
Eligibility Criteria
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.
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Ephedrine usage
Total amount of ephedrine given
intraoperative fluid management
Total amount of fluid given
Apgar scores
Apgar scores in the first and fifth minutes of the newborns
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02958215
Brief Title
Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Obstetrical, Anesthesia, Spinal
Keywords
Orthostatic, Cesarean section, Pregnant, Phenyephrine, Hypotension
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
980 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Intervention Description
it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
5 ml normal saline will be given before spinal anesthesia
Primary Outcome Measure Information:
Title
Incidence of hypotension
Description
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
Time Frame
within first 24 hours after spinal anesthesia
Secondary Outcome Measure Information:
Title
Frequency of bradycardia
Description
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
Time Frame
within first 24 hours after spinal anesthesia
Title
Ephedrine usage
Description
Total amount of ephedrine given
Time Frame
within first 24 hours after spinal anesthesia
Title
intraoperative fluid management
Description
Total amount of fluid given
Time Frame
within first 24 hours after spinal anesthesia
Title
Apgar scores
Description
Apgar scores in the first and fifth minutes of the newborns
Time Frame
within first 24 hours after spinal anesthesia
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed K Abd-Elshafy, MD
Organizational Affiliation
Associate professor of anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Phenylephrine and Hypotension During Spinal Anesthesia for Cesarean Section
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