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Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

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: NCT04272567
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University

Brief Summary:
The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

Condition or disease Intervention/treatment Phase
Adverse Effect Drug: Norepinephrine Drug: Normal saline Not Applicable

Detailed Description:
Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial
Actual Study Start Date : March 28, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Control group
Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion
Drug: Normal saline
Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion
Other Name: NS

Experimental: 0.025 μg/kg/min group
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min).
Drug: Norepinephrine
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.
Other Name: Vasopressors

Experimental: 0.05 μg/kg/min group
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min).
Drug: Norepinephrine
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.
Other Name: Vasopressors

Experimental: 0.075 μg/kg/min group
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min).
Drug: Norepinephrine
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.
Other Name: Vasopressors

Experimental: 0.1 μg/kg/min group
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).
Drug: Norepinephrine
Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.
Other Name: Vasopressors




Primary Outcome Measures :
  1. The incidence of post-spinal anesthesia hypotension [ Time Frame: 1-15 minutes after spinal anesthesia. ]
    Systolic blood pressure (SBP) < 80% of the baseline


Secondary Outcome Measures :
  1. Overall stability of systolic blood pressure control versus baseline [ Time Frame: 1-15 minutes after spinal anesthesia. ]
    Evaluated by performance error (PE).

  2. Overall stability of heart rate control versus baseline [ Time Frame: 1-15 minutes after spinal anesthesia. ]
    Evaluated by performance error (PE).

  3. The incidence of severe post-spinal anesthesia hypotension. [ Time Frame: 1-15 minutes after spinal anesthesia. ]
    Systolic blood pressure (SBP) < 60% of the baseline.

  4. The incidence of nausea and vomiting. [ Time Frame: 1-15 minutes after spinal anesthesia. ]
    Presence of nausea and vomiting in patients after spinal anesthesia

  5. The incidence of bradycardia. [ Time Frame: 1-15 minutes after spinal anesthesia. ]
    Heart rate < 55 beats/min.

  6. The incidence of hypertension. [ Time Frame: 1-15 minutes after spinal anesthesia. ]
    Systolic blood pressure (SBP) >120% of the baseline.

  7. pH [ Time Frame: Immediately after delivery. ]
    From umbilical vein blood gases.

  8. Partial pressure of oxygen [ Time Frame: Immediately after delivery. ]
    From umbilical vein blood gases.

  9. Base excess [ Time Frame: Immediately after delivery. ]
    From umbilical vein blood gases.

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

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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-40 years
  • Primipara or multipara
  • Singleton pregnancy ≥37 weeks
  • American Society of Anesthesiologists physical status classification I to II
  • Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

  • Body height < 150 cm
  • Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
  • Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
  • Hemoglobin < 7g/dl
  • Fetal distress, or known fetal developmental anomaly

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): NCT04272567


Contacts
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Contact: Xinli Ni, Dr. 86-951-674-3252 xinlini6@nyfy.com.cn
Contact: Yi Chen, M.D. 86-951-674-3252 czzyxgp@163.com

Locations
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China, Ningxia
General Hospital of Ningxia Medical University Recruiting
Yinchuan, Ningxia, China, 750004
Contact: Xinli Ni, PhD, MD    +086 951-6743252    xinlii6@yahoo.com   
Sponsors and Collaborators
General Hospital of Ningxia Medical University
Investigators
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Study Chair: Xinli Ni, Dr. General Hospital of Ningxia Medical University
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Responsible Party: General Hospital of Ningxia Medical University
ClinicalTrials.gov Identifier: NCT04272567    
Other Study ID Numbers: Yi Chen-2020-1
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: February 2020

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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 General Hospital of Ningxia Medical University:
Norepinephrine
Hypotension
Cesarean section
Dose-finding
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Norepinephrine
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