Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension
Primary Purpose
Adverse Anesthesia Outcome
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
phenylephrine
Norepinephrine
Bupivacaine
Fentanyl
Placebo (normal saline)
Sponsored by
About this trial
This is an interventional prevention trial for Adverse Anesthesia Outcome
Eligibility Criteria
Inclusion Criteria:
- full term singleton parturients
- elective cesarean sections
Exclusion Criteria:
- cardiac morbidities
- hypertensive disorders of pregnancy
- peripartum bleeding
- body mass index > 35 will be excluded from the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
phenylephrine,
norepinephrine
Arm Description
- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.
- Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.
Outcomes
Primary Outcome Measures
Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)
Secondary Outcome Measures
systolic and diastolic blood pressures measured in mm Hg
heart rate measured in beats per minute
nausea and vomiting measured in number of attacks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03015857
Brief Title
Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension
Official Title
A Comparison Between Phenylephrine and Norepinephrine Boluses in Prevention of Post-spinal Hypotension During Cesarean Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypotension following spinal anesthesia for cesarean section is a serious problem. In this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.
Detailed Description
On arrival to the operating room, an 18g cannula will be inserted and monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). Patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. Ten milligrams heavy bupivacaine in addition to 20 mcg fentanyl will be injected in L3-L4 or L4-L5 interspace using 25 g spinal needle in the sitting position.
After spinal block, patients will be randomly allocated into one of two groups:
Phenylephrine group (n=100)
Norepinephrine group (n=100)
Patients who shows SBP above 140 mmHg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. The infusion will stop if the SBP was above 140 mmHg or if the heart rate was below 55 bpm. Patients will be positioned in the supine position with left lateral tilt. Block success will be assessed using pinprick, patients with failed block will be excluded from the study. The highest sensory block level will be assessed after 5 minutes from intrathecal injection. Co-hydration will be continued till maximum of 1.5 litres.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Anesthesia Outcome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
phenylephrine,
Arm Type
Active Comparator
Arm Description
- Phenylephrine group (n=100): will receive 100 mcg phenylephrine as a single bolus just after intrathecal injection of 10 mg bupivacaine plus 20 mcg fentanyl. The dose will be diluted in 5 mL and given over seconds. A continuous infusion with placebo (normal saline) will start after the first bolus.
Arm Title
norepinephrine
Arm Type
Active Comparator
Arm Description
- Norepinephrine group (n=100): will receive bolus of norepinephrine (10 mcg) directly after spinal block using 10 mg bupivacaine plus 20 mcg fentantanyl followed by continuous infusion of norepinephrine with a rate of 0.1 mcg/kg/min till delivery of the fetus.
Intervention Type
Drug
Intervention Name(s)
phenylephrine
Intervention Description
- phenylephrine; a vasopressor drug given to prevent post spinal hypotension
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Intervention Description
- norepinephrine; a vasopressor drug given to prevent post spinal hypotension
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
intrathecal bupivacaine 10 mg will be given in both groups
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
intrathecal fentanyl 20 mcg will be given in both groups
Intervention Type
Drug
Intervention Name(s)
Placebo (normal saline)
Primary Outcome Measure Information:
Title
Incidence of post spinal hypotension (PSH) defined as percentage of patients with decreased systolic blood pressure less than 80% of the baseline reading during the period from intrathecal injection to delivery of the fetus)
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
systolic and diastolic blood pressures measured in mm Hg
Time Frame
2 hours
Title
heart rate measured in beats per minute
Time Frame
2 hours
Title
nausea and vomiting measured in number of attacks
Time Frame
2 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
full term singleton parturients
elective cesarean sections
Exclusion Criteria:
cardiac morbidities
hypertensive disorders of pregnancy
peripartum bleeding
body mass index > 35 will be excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shereen Refaat, M.D.
Organizational Affiliation
Lecturer of anesthesia Faculty of medicine Cairo university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Tamer M Rook, M.D.
Organizational Affiliation
Lecturer of anesthesia Faculty of medicine Cairo university
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Phenylephrine and Noradrenaline for Post Spinal Anesthesia Hypotension
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