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Norepinephrine Addition in Spinal Anesthesia of Caesarean Section (NASA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626454
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hany M Yassin, MD, Fayoum University Hospital

Brief Summary:
The objective is to compare efficacy of prophylactic norepinephrine bolus versus Infusion in prevention of hypotension which occurs frequently after spinal anesthesia for caesarean section. The authors hypothesize that prophylactic norepinephrine bolus is as effective as infusion in Prevention of hypotension after spinal anesthesia in caesarean section

Condition or disease Intervention/treatment Phase
Hypotension Drug-Induced Drug: Norepinephrine Bolus Drug: Norepinephrine infusion Drug: Normal Saline Flush, 0.9% Injectable Solution Drug: Normal Saline 0.9% Infusion Solution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

An anesthesia resident who will not be involved with the conduct of the study will prepare and label the drug in the syringes according to the randomization codes.

An investigator who will not be involved in subsequent patient care or assessment will open the topmost of 300 opaque sequentially numbered envelopes. One 50 ml and one 10 ml will be labeled as study drug and the 50 ml syringe will be connected to a syringe infusion pump. These two "study drug" syringes will be a part of double dummy technique to facilitate blindness. In group B, 50 ml syringe will contain saline, and 10 ml syringe will contain norepinephrine (.6 µg/ml). In group I, 50 ml syringe will contain norepinephrine (6 µg/ml) with, and 10 ml syringe will contain saline. Participant in both groups will receive bolus from 10 ml syringe over 30 seconds and infusion dose of 1 ml/kg/h simultaneously to expedite blinding.

Primary Purpose: Prevention
Official Title: Efficacy and Safety of Prophylactic Norepinephrine Addition in Prevention of Hypotension During Spinal Anesthesia for Caesarean Delivery: A Randomized Trial
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group B
'Norepinephrine bolus' of 6 µg plus Normal Saline 0.9% Infusion Solution
Drug: Norepinephrine Bolus
'Norepinephrine Bitartarte' bolus of 6 µg/mL for 30 seconds immediately after intrathecal injection
Other Name: NORB

Drug: Normal Saline 0.9% Infusion Solution
50 ml syringe with normal saline infuse at a rate 1ml/kg/h immediately after intrathecal injection
Other Name: NORSI

Active Comparator: group I
'Norepinephrine infusion' 6 µg/kg/h plus 'Normal Saline Flush, 0.9% Injectable Solution
Drug: Norepinephrine infusion
an infusion of 6 µg/mL norepinephrine that was started at 6 µg/kg/h immediately after intrathecal injection
Other Name: NORI

Drug: Normal Saline Flush, 0.9% Injectable Solution
10 ml normal saline in syringe for bolus for 30 seconds immediately after intrathecal injection
Other Name: NORSB




Primary Outcome Measures :
  1. Incidence of hypotension [ Time Frame: 5 to 15 minutes after giving spinal anesthesia ]
    less than 80% baseline blood pressure


Secondary Outcome Measures :
  1. Baseline heart rate [ Time Frame: 3 minutes before giving spinal anesthesia ]
    in beats/min

  2. Baseline mean blood pressure [ Time Frame: 3 minutes before giving spinal anesthesia ]
    in mmHg

  3. Baseline systolic blood pressure [ Time Frame: 3 minutes before giving spinal anesthesia ]
    in mmHg

  4. Anesthesia to delivery time [ Time Frame: from immediately after giving anesthesia until delivery of fetus by surgeon ]
    in minutes

  5. Incision to delivery time [ Time Frame: in time of beginning of surgical incision of skin until delivery of fetus by surgeon ]
    in minutes

  6. Uterine incision to delivery time [ Time Frame: in time of beginning of uterine incision until delivery of fetus by surgeon ]
    in seconds

  7. Presence of Nausea [ Time Frame: 30 minutes ]
    Presence of nausea in patients from induction of spinal anesthesia to delivery of the fetus.

  8. Presence of vomiting [ Time Frame: 30 minutes ]
    Presence of vomiting in patients from induction of spinal anesthesia to delivery of the fetus.

  9. Incidence of hypertension [ Time Frame: 30 minutes ]
    Systolic blood pressure at or above 120% of baseline, from induction of spinal anesthesia to delivery of the fetus

  10. Occurence of bradycardia [ Time Frame: 30 minutes ]
    Heart rate less than 50 bpm, from induction of spinal anesthesia from induction of spinal anesthesia to delivery of the fetus

  11. Occurence of tachycardia [ Time Frame: 30 minutes ]
    Heart rate more than 120 bpm, from induction of spinal anesthesia from induction of spinal anesthesia to delivery of the fetus

  12. Upper sensory level of anesthetic block [ Time Frame: 3 minutes after giving spinal anesthesia ]
    assessment by pin prick

  13. Umbilical artery pH [ Time Frame: 1 minute after delivery ]
    from umbilical artery blood gases

  14. Umbilical vein pH [ Time Frame: 1 minute after delivery ]
    from umbilical vein blood gases

  15. Umbilical artery partial pressure of carbon dioxide [ Time Frame: 1 minute after delivery ]
    from umbilical artery blood gases

  16. Umbilical vein partial pressure of carbon dioxide [ Time Frame: 1 minute after delivery ]
    from umbilical vein blood gases

  17. Umbilical artery partial pressure of oxygen [ Time Frame: 1 minute after delivery ]
    from umbilical artery blood gases

  18. Umbilical vein partial pressure of oxygen [ Time Frame: 1 minute after delivery ]
    from umbilical vein blood gases

  19. Umbilical artery bicarbonate [ Time Frame: 1 minute after delivery ]
    from umbilical artery blood gases

  20. Umbilical artery base excess [ Time Frame: 1 minute after delivery ]
    from umbilical artery blood gases

  21. Umbilical vein bicarbonate [ Time Frame: 1 minute after delivery ]
    from umbilical vein blood gases

  22. Umbilical vein base excess [ Time Frame: 1 minute after delivery ]
    from umbilical vein blood gases

  23. APGAR score [ Time Frame: 1 minute after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

  24. APGAR score [ Time Frame: 5 minutes after delivery ]
    A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

  25. Rescue ephedrine dose [ Time Frame: every 2 minutes up to 30 minutes immediately after occurence of hypotension ]
    10 mg given intravenous

  26. first rescue ephedrine dose time [ Time Frame: 1 minute after giving rescue ephedrine ]
    in min

  27. Total used ephedrine dose [ Time Frame: 1 minute after correction of blood pressure ]
    in mg


Other Outcome Measures:
  1. Age [ Time Frame: 1 hour before operation once the patient recruited ]
    in years

  2. Weight [ Time Frame: 1 hour before operation once the patient recruited ]
    In kilograms

  3. Height [ Time Frame: 1 hour before operation once the patient recruited ]
    In meters

  4. BMI [ Time Frame: 1 hour before operation once the patient recruited ]
    In kilogram per square meter

  5. Gestational age [ Time Frame: 1 hour before operation once the patient recruited ]
    in weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 - 45 years
  • American Society of Anesthesiologists physical status classification II or III
  • Elective caesarean section under spinal anesthesia
  • Normal singleton pregnancy beyond 36 weeks gestation
  • Weight 50-100 kg, height 150-180 cm

Exclusion Criteria:

  • Patient refusal
  • Allergy or hypersensitivity to norepinephrine
  • Diabetes, excluding gestational diabetes
  • Preexisting or pregnancy-induced hypertension
  • Arrhythmia
  • Cerebrovascular disease
  • Known fetal abnormality or fetal distress
  • Any contraindication to spinal anesthesia
  • Use of monoamine oxidase inhibitors, triptyline or imipramine antidepressants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626454


Contacts
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Contact: Yasser S Mostafa, M.Sc. 01010509735 ext +2 ysm03@fayoum.edu.eg
Contact: Hany M Yassin, M.D. 01111363602 ext +2 hmyoo@fayoum.edu.eg

Locations
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Egypt
Fayoum University hospital Recruiting
Madīnat al Fayyūm, Faiyum Governorate, Egypt, 63514
Contact: Hany M Yassin, MD.    1111363602 ext +20    hmy00@fayoum.edu.eg   
Contact: Yasser S Mostafa, M.Sc.    1010509735 ext +20    ysm03@fayoum.edu.eg   
Sponsors and Collaborators
Fayoum University Hospital
Investigators
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Study Chair: Hany M Yassin, M.D. Fayoum University
Publications:

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Responsible Party: Hany M Yassin, MD, Associate professor of anesthesia, Fayoum University Hospital
ClinicalTrials.gov Identifier: NCT03626454    
Other Study ID Numbers: NASA2018
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hany M Yassin, MD, Fayoum University Hospital:
Norepinephrine, hypotension, spinal, caesarean section
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Norepinephrine
Pharmaceutical Solutions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents