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Comparison of Two Norepinephrine Bolus Doses for Management of Hypotension During Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT03712111
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Tracking Information
First Submitted Date  ICMJE October 16, 2018
First Posted Date  ICMJE October 19, 2018
Last Update Posted Date November 22, 2018
Actual Study Start Date  ICMJE November 21, 2018
Estimated Primary Completion Date June 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
Rate of successful management of maternal hypotension [ Time Frame: 30 minutes after spinal anesthesia ]
number of patients with successful management of maternal hypotensive episode (defined as return of systolic blood pressure to be ≥ 80% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03712111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • Rate of successful management of severe maternal hypotension [ Time Frame: 30 minutes after spinal anesthesia ]
    number of patients with successful management of maternal severe hypotensive episode (defined as systolic blood pressure lower than 60% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus)
  • incidence of reactive hypertension [ Time Frame: 30 minutes after spinal anesthesia ]
    number of patients with reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading after administration of norepinephrine bolus)
  • systolic blood pressure [ Time Frame: 90 minutes after spinal anesthesia ]
    systolic blood pressure measured in mmHg
  • heart rate [ Time Frame: 90 minutes after spinal block ]
    number of heart beats per minute
  • Apgar score for evaluation of the activity of the fetus [ Time Frame: 10 minutes ]
    the Apgar score of the fetus which range from 0 to 10. Th minimum value is 0 and the maximum value is 10. The worst value is 0 and the best value is 10
  • Umbilical blood acidity [ Time Frame: 10 minutes after delivery ]
    the measure of acidity or alkalinity of any solution on a logarithmic scale on which 7 is neutral, lower values are more acid and higher values more alkaline.
  • The frequency of vomiting [ Time Frame: 90 minutes after spinal anesthesia ]
    The number of patients with vomiting
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Rate of successful management of severe maternal hypotension [ Time Frame: 30 minutes after spinal anesthesia ]
    number of patients with successful management of maternal severe hypotensive episode (defined as systolic blood pressure lower than 60% of the baseline reading in the next reading 2 minutes after administration of norepinephrine bolus)
  • incidence of reactive hypertension [ Time Frame: 30 minutes after spinal anesthesia ]
    number of patients with reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading after administration of norepinephrine bolus)
  • systolic blood pressure [ Time Frame: 90 minutes after spinal anesthesia ]
    systolic blood pressure measured in mmHg
  • heart rate [ Time Frame: 90 minutes after spinal block ]
    number of heart beats per minute
  • Apgar score for evaluation of the activity of the fetus [ Time Frame: 10 minutes ]
    the Apgar score of the fetus which range from 0 to 10. Th minimum value is 0 and the maximum value is 10. The worst value is 0 and the best value is 10
  • Umbilical blood acidity [ Time Frame: 10 minutes after delivery ]
    the measure of acidity or alkalinity of any solution on a logarithmic scale on which 7 is neutral, lower values are more acid and higher values more alkaline.
  • Vomiting [ Time Frame: 90 minutes after spinal anesthesia ]
    The percent of patients with vomiting
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Norepinephrine Bolus Doses for Management of Hypotension During Cesarean Delivery
Official Title  ICMJE Norepinephrine for Management of Post-spinal Hypotension During Cesarean Delivery: a Randomized, Controlled, Comparison of Two Bolus Doses
Brief Summary In this study the investigators will compare the efficacy and side effects of two doses of norepinephrine bolus (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during Cesarean delivery.
Detailed Description

Maternal hypotension after subarachnoid block is a frequent and deleterious complication during cesarean delivery. Although prophylaxis against hypotension using vasopressors had become a standard recommendation; the incidence of hypotension is still ∼ 20% . Thus; management of maternal hypotension using vasopressor boluses is usually needed .

The commonly used vasopressors during cesarean delivery are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and fetal acidosis. Phenylephrine had been the first line for prevention and management of maternal hypotension; however, its use might result in bradycardia and decreased maternal cardiac output .

Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. Norepinephrine was introduced for use during cesarean delivery with promising results . Few previous studies investigated the efficacy of Norepinephrine infusion for prevention of maternal hypotension. A dose-response study had investigated the best dose of Norepinephrine for prevention of maternal hypotension. In the aforementioned dose-response study, a dose of 6 mcg was reported as the best dose for prophylaxis against maternal hypotension.

No studies had investigated the best bolus dose of norepinephrine for management of a maternal hypotensive episode. In this study the investigators will investigate the efficacy and side effects of two doses of norepinephrine bolus doses (6 mcg and 10 mcg) in management of maternal hypotensive episode after subarachnoid block during cesarean delivery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cesarean Section Complications
  • Spinal Anesthetic Toxicity
Intervention  ICMJE
  • Drug: Norepinephrine 6 mcg
    An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.
    Other Name: Levophed
  • Drug: Norepinephrine 10 mcg
    An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.
    Other Name: Levophed
  • Drug: Bupivacaine Hydrochloride
    Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg
    Other Name: Marcaine
  • Drug: Norepinephrine infusion
    Prophylactic norepinephrine infusion will be started after subarachnoid block
    Other Name: Levophed
Study Arms  ICMJE
  • Experimental: Norepinephrine 6 mcg
    Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion
    Interventions:
    • Drug: Norepinephrine 6 mcg
    • Drug: Bupivacaine Hydrochloride
    • Drug: Norepinephrine infusion
  • Active Comparator: Norepinephrine 10 mcg
    Mothers in this group will receive a bolus of Norepinephrine 10 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride under prophylactic Norepinephrine infusion
    Interventions:
    • Drug: Norepinephrine 10 mcg
    • Drug: Bupivacaine Hydrochloride
    • Drug: Norepinephrine infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2018)
86
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2018)
50
Estimated Study Completion Date  ICMJE July 1, 2019
Estimated Primary Completion Date June 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • pregnant women
  • scheduled for cesarean delivery

Exclusion Criteria:

  • patients with severe cardiac dysfunction
  • patients with low blood pressure
  • patients with ante-partum bleeding
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Amin, Lecturer +201227476617 sarahamin_22@hotmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03712111
Other Study ID Numbers  ICMJE N-71-2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ahmed Hasanin, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmed Hasanin, Professor Assistant professor of anesthesia
PRS Account Cairo University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP