Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery
Primary Purpose
Hypotension Drug-Induced
Status
Completed
Phase
Phase 4
Locations
Colombia
Study Type
Interventional
Intervention
Phenylephrine
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension Drug-Induced
Eligibility Criteria
Inclusion Criteria:
- pregnant subjects who are to be delivered to cesarean section under subarachnoid anesthesia
- Gestational age >37 weeks
Exclusion Criteria:
Pregnant subjects with:
- Hipertensive disorders in pregnancy
- Acute fetal distress
- Evidence of placental dysfunction
- History of cardiovascular or cerebrovascular diseases
- hypersensitivity to phenylephrine
- Rejection of the patient
Sites / Locations
- Clinic materno infaltil San Luis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
group 1
group 2
Arm Description
Phenylephrine 40 mcg/min, infusion during 5 minutes
Saline solution 21 cc, infusion during 5 minutes
Outcomes
Primary Outcome Measures
Hypotension
Secondary Outcome Measures
heart rate
Newborn APGAR
Full Information
NCT ID
NCT02979405
First Posted
November 29, 2016
Last Updated
February 22, 2017
Sponsor
Universidad Industrial de Santander
1. Study Identification
Unique Protocol Identification Number
NCT02979405
Brief Title
Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery
Official Title
Effectivenes of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
February 20, 2017 (Actual)
Study Completion Date
February 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Industrial de Santander
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Hypotension in patients who are taken to surgery, is a very frequent complication, when the spinal anesthetical technique is used, associating this with significant adverse effects that can lead to morbidity specially in the obstetric patient. The objective of the study is determine if the phenylephrine used of prophylactic form, achieved to prevent the appearance of hypotension in obstetric patients led to Caesarea under spinal anesthesia.
Detailed Description
Worldwide, the caesarean section is one of the surgical procedures most frequently performed, representing a challenge to the anesthesiologist, who must administer anesthesia to the mother with minimal effects in the newborn. For this reason, spinal anesthesia emerges as an important option in the management of the obstetrical patient who is going to be taken to Caesarea. The hypotension, is one of the most frequent events adverse associated to this technical anesthetic, represented a risk of complications both, in the mother as in the fetus, by this reason the anesthesiologist must implement different strategies to treat it when this be present. From there arises the necessity of establishing if the phenylephrine, a drug used to treat hypotension, when is administed prophylactically, allows to avoid this effect. We designed a randomized clinical trial in elderly patients over 18 years who are taken to Caesarea, where they formed two groups of patients, one that will administer a prophylactic infusion of phenylephrine compared with placebo, assessing the incidence of hypotension in the two groups and the adverse events most commonly associated with this.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension Drug-Induced
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
Phenylephrine 40 mcg/min, infusion during 5 minutes
Arm Title
group 2
Arm Type
Placebo Comparator
Arm Description
Saline solution 21 cc, infusion during 5 minutes
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
prophylactic Phenylephrine
Intervention Description
prophylactic infusion of phenylephrine 40 mcg/min
Primary Outcome Measure Information:
Title
Hypotension
Time Frame
caesarean delivery
Secondary Outcome Measure Information:
Title
heart rate
Time Frame
caesarean delivery
Title
Newborn APGAR
Time Frame
Turn off of the newly born: measured to the 1 and 5 minutes from the birth
Other Pre-specified Outcome Measures:
Title
Nausea
Time Frame
surgical procedure
Title
Vomiting
Time Frame
surgical procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pregnant subjects who are to be delivered to cesarean section under subarachnoid anesthesia
Gestational age >37 weeks
Exclusion Criteria:
Pregnant subjects with:
Hipertensive disorders in pregnancy
Acute fetal distress
Evidence of placental dysfunction
History of cardiovascular or cerebrovascular diseases
hypersensitivity to phenylephrine
Rejection of the patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hector Meléndez, Dr
Organizational Affiliation
Universidad Industrial de Santander
Official's Role
Study Director
Facility Information:
Facility Name
Clinic materno infaltil San Luis
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
68003
Country
Colombia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Phenylefrine in Prevention of Hypotension During Spinal Anesthesia for Cesarean Delivery
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