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Trial record 24 of 536 for:    decongestants

Manging Post Spinal Hypotension During Elective Cesarean Section (EpiEph)

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ClinicalTrials.gov Identifier: NCT03704909
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Ben marzouk Sofiene, University Tunis El Manar

Brief Summary:
Spinal anesthesia is the gold standard technique for elective cesarean section. It helps to avoid risks regarding airway management and provides effective neuraxial postoperative analgesia, enabling quicker maternal recovery. Cesarean section normally require an anesthetic block at T4 level. So that maternal hypotension is reported to occur in up to 80%. This can result in significant morbidity for both the mother and fetus.The purpose of this study is to determine if epinephrine is as effective and safe compared to ephedrine for maintaining arterial blood pressure during elective cesarean section under spinal anesthesia. All participants will receive spinal anesthesia with a local anesthetic and sufentanil. This study plans to enroll 140 healthy pregnant women. Patients will be randomly assigned according to a computer generated system to be in one of two groups.

Condition or disease Intervention/treatment Phase
Hypotension Drug: Adrenaline Drug: Ephedrine Phase 4

Detailed Description:

Its a prospective double-blinded controlled trial. All participants gave a written informed consent. One hundred and twenty healthy women, ASA II, with singleton pregnancies at term scheduled for elective cesarean section under spinal anesthesia are targeted for the study. They are randomized to receive either epinephrine or ephedrine. Upon arrival in the operating room, parturient was placed in the supine position with 15° left lateral tilt with routine monitoring (HR, non-invasive BP, pulse oximetry, electrocardiography). Baseline BP and HR were computed as the mean of three consecutive BP and HR readings respectively at 1-minute intervals. Study participants will receive a standard spinal anesthetic consisting of 0.5% hyperbaric bupivacaine (2 mL) plus sufentanil (5 µg) at L3-4 vertebral interspace.

Group A (for adrenaline group): received a prophylactic intravenous (i.v) bolus of Epinephrine 0.15µg/Kg at time of SA. In this group, rescue boluses of Epinephrine 0.15µg/Kg, were given if maternal BP decreased more than 20% from the baseline value.

Group E (for ephedrine group): received a prophylactic i.v bolus of Ephedrine 0.1mg/Kg at time of SA. In this group, rescue boluses of Ephedrine 0.1mg/Kg, were given if maternal BP decreased more than 20% from the baseline value. Once the spinal injection was performed a rapid intravenous (i.v.) coload with 15mL/Kg of isotonic saline solution was started through a 16 G i.v. cannula (by turning the i.v. infusion to maximum and using a pressure bag inflated to 150 mmHg). A prophylactic bolus of vasopressor was administered at the end of spinal injection. After performing anesthesia, the parturient was immediately replaced in the supine position with a 15° left lateral table tilt until delivery of the infant. Prior to surgical incision, the spinal sensory level will be tested to the bilateral T6-T4 dermatomal level. Sensory block level was checked by cold-hot test and the Modified Bromage Scale was used for the assessment of motor block. The surgery was allowed when the sensory block level reached D4. Both the patient and the researcher's assistant (who will collect data) will be blinded as to the administered Epinephrine or Ephedrine bolus. Supplemental oxygen will be given only when the pulse oximeter reading decreased below 95%. After delivery, 5 IU of oxytocin diluted in 20 ml of isotonic saline solution were slowly injected over 1 minute. Then an i.v infusion was given (10 IU/500ml of isotonic saline solution at a flow rate of 28 drops/min).

Heart rate (beats/min), systolic, mean and diastolic blood pressure (mmHg) will be recorded every 1 min after spinal injection until the end of surgery. The incidence of hypotension (defined as a reduction in SBP of >20% from baseline determined just before the administration of spinal anesthesia) will be recorded. Reactive hypertension (defined as a rise of SBP >20% of baseline) will also be recorded. Bradycardia (defined as HR <50 beats/min) will be recorded. Tachycardia (defined as a HR >140 beats/min) will also be recorded. Umbilical blood samples will be obtained by clamping it on both sides and a gas analysis will be performed to determine fetal pH, HCO3-, base excess and lactates. Furthermore, Apgar scores at 1 and 5 minutes after delivery will be recorded by the attending pediatrician, who will be unaware of the vasopressor used. The study will end when cesarean section is completed and the patient is transferred to the post-operative care unit.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Managing Post Spinal Hypotension During Elective Cesarean Section: Epinephrine Versus Ephedrine, a Randomized Double-blinded Controlled Trial
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018


Arm Intervention/treatment
Active Comparator: Group Adrenaline: Group A
All parturients received a prophylactic i.v bolus of Epinephrine 0.15µg/Kg at time of SA. In this group, rescue boluses of Epinephrine 0.15µg/Kg, will be given if maternal BP decreased more than 20% from the baseline value.
Drug: Adrenaline
i.v bolus of adrenaline 0.15µg/Kg rescue boluses of adrenaline 0.15µg/Kg
Other Name: epinehrine

Active Comparator: Group Ephedrine: Group E
All parturients received a prophylactic i.v bolus of Ephedrine 0.1mg/Kg at time of SA. In this group, rescue boluses of Ephedrine 0.1mg/Kg, will be given if maternal BP decreased more than 20% from the baseline value.E
Drug: Ephedrine
i.v bolus of Ephedrine 0.1mg/Kg rescue boluses of Ephedrine 0.1mg/Kg




Primary Outcome Measures :
  1. delta SBP (D) [ Time Frame: at the end of intrathecal injection until delivery ]
    difference between baseline and the lowest systolic blood pressure.

  2. delta MBP (D) [ Time Frame: at the end of intrathecal injection until delivery ]
    difference between baseline and the lowest mean blood pressure.


Secondary Outcome Measures :
  1. delta SBP (S) [ Time Frame: at the end of intrathecal injection until the end of surgery ]
    difference between baseline and the lowest systolic blood pressure.

  2. delta MBP (S) [ Time Frame: at the end of intrathecal injection until the end of surgery ]
    difference between baseline and the lowest mean blood pressure.

  3. time to onset of first post spinal hypotension episode [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    first episode of hypotension after spinal anesthesia induction

  4. Incidence of post spinal hypotension [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    a decrease of SBP >20% of baseline

  5. Vasopressor consumption [ Time Frame: from the end of intrathecal injection until delivery. ]
    cumulative dose of vasopressor consumption

  6. Vasopressor consumption [ Time Frame: from the end of intrathecal injection until the end of surgery. ]
    cumulative dose of vasopressor consumption

  7. number of rescue boluses [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    number of rescue boluses before and after delivery

  8. incidence of hypertension [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    a rise of SBP >20% of baseline

  9. tachycardia [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    heart rate>140 beats/min

  10. incidence of arrythmia [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    incidence of arrhythmic events

  11. incidence of bradycardia [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    heart rate (HR) < 50 beats/min

  12. use of atropine [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    cumulative dose, if needed

  13. incidence of nausea and vomiting [ Time Frame: At time of surgery (right after spinal anesthesia until end of surgery) ]
    Measure will be done according to a simple scale: 0= no nausea and vomiting; 1= nausea or vomiting

  14. foetal gas analysis: pH, Lactates, HCO3-, BE [ Time Frame: At time of birth ]
    fetal cord blood analysis will be done immediately after delivery

  15. APGAR score [ Time Frame: at 1 and 5 minutes after birth ]
    range from 0 to 10,incorporates five elements: respiratory effort, heart rate, reflex irritability, muscle tone, and color A score of 0 to 3 indicates a severely depressed neonate, whereas a score of 7 to 10 is considered normal.



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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:

  • ASA II
  • BMI>18 and <35 Kg/m2
  • full term parturients with singleton pregnancy
  • scheduled of elective cesarean section under spinal anesthesia

Non-inclusion criteria:

  • Patient refusal.
  • ASA > II
  • Preexisting or pregnancy-induced hypertension
  • The use of cardiac medication or medication for BP control.
  • Cardiovascular or cerebrovascular disease.
  • Multiple pregnancy.
  • Suspicion of abnormal placentation.
  • Known fetal abnormalities or fetal distress.
  • CS under general anesthesia.
  • Active labor.
  • Emergency.
  • Allergy to any of the medications used in the study.

Exclusion Criteria:

  • Hemodynamic instability that is not in relationship with SA (occurrence of a surgical per-operative complication e.g. bleeding by placental insertion abnormality or a uterine atony).
  • An abnormal extension of the anesthetic block defined as a sensory block level > D4.
  • SA failure.
  • The need to convert to general anesthesia.

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): NCT03704909


Locations
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Tunisia
Tunis maternity and neonatology center,
Tunis, Tunisia, 1007
Sponsors and Collaborators
Ben marzouk Sofiene
Investigators
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Study Chair: HAYEN MAGHREBIG, PROFESSOR UNIVERSITY OF TUNIS EL MANAR

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Responsible Party: Ben marzouk Sofiene, clinical associate professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03704909     History of Changes
Other Study ID Numbers: Adrenaline
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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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 Ben marzouk Sofiene, University Tunis El Manar:
Epinephrine, Ephedrine, cesarean section, spinal anesthesia

Additional relevant MeSH terms:
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Ephedrine
Nasal Decongestants
Hypotension
Vascular Diseases
Cardiovascular Diseases
Epinephrine
Racepinephrine
Pseudoephedrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Central Nervous System Stimulants