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Trial record 16 of 536 for:    decongestants

Ephedrine and Phenylephrine for Spinal Hypotension

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ClinicalTrials.gov Identifier: NCT03047109
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
MOHAMED F. MOSTAFA, Assiut University

Brief Summary:

Spinal anesthesia is widely used as the procedure of choice for cesarean delivery. In comparison to epidural anesthesia it is faster, easier to perform, patients are more comfortable, complication rates are lower, and it is more cost effective. Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women.

Spinal block causes peripheral vasodilation and venous pooling, which may result in maternal hypotension. Maternal hypotension after spinal anesthesia for cesarean delivery, without prophylactic measures, has a very high incidence (80%-100%). Even though highly investigated, spinal induced hypotension remains a major concern, and it has been referred to as the "Holy Grail" of obstetric anesthesia. The detrimental effects of the spinal induced hypotension are maternal and fetal. Maternal effects are nausea, vomiting and dizziness. Hypotension results in reduced uterine and intervillous blood flow with potential fetal hypoxia and acidosis.

Treatment and prevention of hypotension has been the subject of much investigation and controversy. Prophylactic measures include: 1) left lateral tilt, 2) fluid preload, 3) vasopressors,4) low dose spinal anesthesia. A 15° left lateral tilt is used routinely during cesarean section, to prevent aorto-caval compression, however it is not sufficient as a sole method. Left uterine displacement is achieved by tilting the operating table or by placing a wedge under the woman's hip. Aorto-caval compression also may increase the spread of spinal anesthesia. Among the non-pharmacological interventions studied to minimize the incidence of hypotension sitting the patient up for up to 7 min after CSE anesthesia for cesarean section reduced intraoperative ephedrine requirement without affecting the success of the spinal anesthetic. In contrast, sitting up for 9 min resulted in the need for rescue epidural anesthesia without additional benefit.

Phenylephrine Treatment of vascular failure in shock, shock-like states, drug-induced hypotension or hypersensitivity; correction of paroxysmal supraventricular tachycardia; prolongation of spinal anesthesia; vasoconstriction in regional analgesia; maintenance of adequate level of BP during spinal and inhalation anesthesia. It has a number of important attributes for treating spinal hypotension: (i) as an alpha-adrenergic agonist, its mechanism of action directly addresses the decrease in systemic vascular resistance following spinal anesthesia;(ii) phenylephrine has a faster onset of action compared with ephedrine; (iii) ephedrine is associated with a five-fold increased risk of fetal acidosis; and (iv) ephedrine is more likely to cross the placenta and increase concentrations of lactate, glucose, and catecholamines in the fetal circulation compared with phenylephrine. However, phenylephrine used alone may be accompanied by maternal bradycardia and does not benefit from widespread clinical experience, as does ephedrine do. Thus, phenylephrine has not yet become popular, particularly for prophylactic use. Clinical experience suggests that phenylephrine may be useful in addition to ephedrine when the latter fails to correct hypotension.

Ephedrine sulphate is a potent sympathomimetic that stimulates both α and β receptors and has clinical uses related to both actions. Its peripheral actions, which it owes in part to the release of norepinephrine, simulate responses that are obtained when adrenergic nerves are stimulated. These include an increase in blood pressure, stimulation of heart muscle, constriction of arterioles.


Condition or disease Intervention/treatment Phase
Spinal Hypotension Drug: Phenylephrine Drug: Ephedrine Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Ephedrine Versus Phenylephrine Infusion for Prevention of Spinal Hypotension During Cesarean Section: Effect on Maternal Cardiodynamics and Fetal Circulation: Randomized Double-blind Study
Actual Study Start Date : February 7, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019


Arm Intervention/treatment
Active Comparator: Group P
Patients will receive Phenylephrine 30 µg/minute by syringe pump infusion for 30 minutes.
Drug: Phenylephrine
50 patients will receive Phenylephrine 30 µg/minute by syringe pump infusion for 30 minutes.

Active Comparator: Group E
Patients will receive Ephedrine 3 mg/ minute by syringe pump infusion for 30 minutes.
Drug: Ephedrine
50 patients will receive Ephedrine 3 mg/ minute by syringe pump infusion for 30 minutes.




Primary Outcome Measures :
  1. Maternal Cardiac Output [ Time Frame: 30 minutes ]
    maternal cardiac output will be done using non-invasive thoracic bio-impedance monitor


Secondary Outcome Measures :
  1. Uterine Blood Flow Indices [ Time Frame: 30 minutes ]
    uterine blood flow indices will be done using Doppler

  2. Complications [ Time Frame: 2 hours ]
    Percentage of patients with any complications will be recorded and treated



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 20-35 years.
  • ASA physical I-II
  • Singleton term pregnancy.
  • Elective cesarean section.

Exclusion Criteria:

  • Parturient refusal.
  • Women with history of cardiac, respiratory, renal, neurologic or endocrine diseases.
  • Women with known allergy to amide local anesthetics or any medications used in the study.
  • Any contraindications to regional anesthesia e.g. coagulopathy.
  • Pre-eclampsia.
  • Fetal abnormalities.
  • Emergency surgeries.
  • Failed or unsatisfactory spinal block.

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): NCT03047109


Contacts
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Contact: MOHAMED F. MOSTAFA, MD 01001123062 ext 002 mo7_fathy@yahoo.com
Contact: HAMDY A. YOUSSEF, MD 01090008490 ext 002 hamdyayoussef@yahoo.com

Locations
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Egypt
Assiut university hospital Recruiting
Assiut, Egypt, 71515
Contact: MOHAMED F MOSTAFA, ND    01001123062 ext 002    mo7_fathy@yahoo.com   
Contact: HAMDY A YOUSSEF, MD    01090008490 ext 002    hamdyayoussef@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: HAMDY A. YOUSSEF, MD Assiut University

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Responsible Party: MOHAMED F. MOSTAFA, Lecturer of Anesthesia and Intensive Care, Assiut University
ClinicalTrials.gov Identifier: NCT03047109     History of Changes
Other Study ID Numbers: Phenylephrine Hypotension
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 MOHAMED F. MOSTAFA, Assiut University:
Ephedrine
Phenylephrine
Spinal Hypotension
Cesarean Section
Maternal Cardiodynamics

Additional relevant MeSH terms:
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Ephedrine
Nasal Decongestants
Hypotension
Vascular Diseases
Cardiovascular Diseases
Phenylephrine
Oxymetazoline
Pseudoephedrine
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Stimulants
Bronchodilator Agents
Anti-Asthmatic Agents