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Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507387
Recruitment Status : Completed
First Posted : April 25, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Chao Xu, Xuzhou Medical University

Brief Summary:
Spinal anesthesia is the preferred anesthesia method in cesarean section to provide satisfactory analgesia and muscle relaxant with less impact on respiratory system. However, hypotension often occurred due to the block of sympathetic nerve, causing maternal decline of frontal lobe oxygenation, nausea vomit and the decrease of uteroplacental perfusion. Several measures are used to prevent or treat hypotension caused by spinal anesthesia: prehydration, limb compression, left lateral tilt of operation tables or usage of vasopressors. In the past decade, the most recommended vasopressor to prevent or treat hypotension in spinal anesthesia in cesarean section was phenylephrine, an α-adrenergic receptor, maintaining maternal blood pressure and fetal acid-base state. In clinical work, there are two ways to use phenylephrine : intravenous method with less onset time (several seconds and duration (several minutes) and intramuscular method with longer onset time (10-15 minutes) and duration (1 hour). Many trials demonstrated the protective effect of preventive intravenous phenylephrine on maternal hemodynamics and neonatal acid-base status. However, few trials reported the effect of preventive intramuscular phenylephrine on cesarean section under spinal anesthesia.

Condition or disease Intervention/treatment Phase
Elective Cesarean Section Spinal Anesthesia Drug: Phenylephrine Drug: Normal saline Drug: Bupivacaine Not Applicable

Detailed Description:
Hypotension often occurred in parturients undergoing cesarean section in spinal anesthesia. This study aims to determine whether preventive intramuscular phenylephrine can better the fetal acid-base state and maternal hemodynamics.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Tiral
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018


Arm Intervention/treatment
Experimental: Intramuscular phenylephrine group
Patients in intramuscular phenylephrine group will receive spinal anesthesia with bupivacaine. 5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.
Drug: Phenylephrine
5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed .
Other Name: Metasympatol

Drug: Normal saline
1ml 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia and after the subarachnoid injection is completed.
Other Name: Physiological saline

Drug: Bupivacaine
All patients will receive spinal anesthesia with bupivacaine.
Other Name: Marcaine

Active Comparator: Intravenous phenylephrine group
Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed.
Drug: Phenylephrine
5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed .
Other Name: Metasympatol

Drug: Normal saline
1ml 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia and after the subarachnoid injection is completed.
Other Name: Physiological saline

Drug: Bupivacaine
All patients will receive spinal anesthesia with bupivacaine.
Other Name: Marcaine

Placebo Comparator: Placebo group
Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia. 1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.
Drug: Phenylephrine
5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed .
Other Name: Metasympatol

Drug: Normal saline
1ml 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia and after the subarachnoid injection is completed.
Other Name: Physiological saline

Drug: Bupivacaine
All patients will receive spinal anesthesia with bupivacaine.
Other Name: Marcaine




Primary Outcome Measures :
  1. Umbilical artery potential of hydrogen (pH) [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer


Secondary Outcome Measures :
  1. Umbilical venous potential of hydrogen (pH) [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  2. Umbilical artery base excess [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  3. Umbilical venous base excess [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  4. Umbilical artery partial pressure of oxygen (PaO2) [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  5. Umbilical venous partial pressure of oxygen (PaO2) [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  6. Umbilical artery partial pressure of carbon dioxide (PaCO2) [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  7. Umbilical venous partial pressure of carbon dioxide (PaCO2) [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  8. Umbilical artery lactate [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  9. Umbilical venous lactate [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  10. Umbilical artery glucose [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  11. Umbilical venous glucose [ Time Frame: after the baby is delivered ]
    detected by a blood gase analyzer

  12. Incidence of fetal acidosis [ Time Frame: after the baby is delivered ]
    Umbilical artery pH value<7.20

  13. Incidence of hypotension [ Time Frame: intraoperative ]
    decrease of systolic blood pressure>20% baseline values

  14. Incidence of hypertension [ Time Frame: intraoperative ]
    increase of systolic blood pressure>20% baseline values

  15. Incidence of bradycardia [ Time Frame: intraoperative ]
    heart rate <50 bpm

  16. Incidence of nausea or vomit [ Time Frame: intraoperative ]
    observed by the anesthesiologist



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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:

  1. Age 18 years to 40 years.
  2. Elective cesarean section
  3. American Society of Anesthesiologists (ASA) grade from I to Ⅱ, height from 150 cm to 180 cm, BMI<40kg/m2
  4. Singleton pregnancy
  5. Without pregnancy complications

Exclusion Criteria:

  1. Multiple pregnancy
  2. Preoperative bradycardia
  3. Coagulation dysfunction
  4. Parturients with hypertension, diabetes, eclampsia and other pregnancy complications.

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): NCT03507387


Locations
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China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Sponsors and Collaborators
Xuzhou Medical University
Investigators
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Principal Investigator: Chao Xu, M.D. The Affiliated Hospital of Xuzhou Medical University
Publications of Results:

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Responsible Party: Chao Xu, Principal Investigator, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03507387    
Other Study ID Numbers: XYFY2018-KL010-01
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: July 5, 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 Chao Xu, Xuzhou Medical University:
Intramuscular
Phenylephrine
Additional relevant MeSH terms:
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Phenylephrine
Oxymetazoline
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents