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Cyclizine Vs. Dexamethasone for Nausea and Vomiting Following Intrathecal Morphine in Cases of Cesarean Section

Primary Purpose

Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female
  • 18 to 45 years old
  • Parturient
  • ASA I-II
  • Full Term

Exclusion Criteria:

  • Women who has obstetric complications.
  • Women with evidence of foetal compromise.
  • Patients who have gastro-intestinal diseases.
  • Administration of anti-emetic drugs within 24 hours before operation.
  • Patients who have hyperemesis gravidarium

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Dexamethasone

    Cyclizine

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Post operative nausea and vomiting after intrathecal morphine by using PONV intensity scale.
    Nausea and vomiting were recorded as present or absent, All measurements and ratings were completed at the time when patients rated their PONV intensity. We also recorded factors known to be associated with the risk of developing PONV, including known risk factors for PONV.

    Secondary Outcome Measures

    Change in postoperative pain (assessed by VAS ).
    0 meaning no pain at all, and 10 described as the worst pain experienced.

    Full Information

    First Posted
    March 26, 2019
    Last Updated
    April 25, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03931135
    Brief Title
    Cyclizine Vs. Dexamethasone for Nausea and Vomiting Following Intrathecal Morphine in Cases of Cesarean Section
    Official Title
    Comparison Between Cyclizine and Dexamethasone for Prevention of Nausea and Vomiting After Intrathecal Morphine in Patients Undergoing Cesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2019 (Anticipated)
    Primary Completion Date
    October 31, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Comparing between cyclizine and dexamethasone in preventing PONV after CS under spinal anesthesia with spinal opiate.
    Detailed Description
    Postoperative nausea and vomiting (PONV) is defined as any nausea, retching, or vomiting occurring during the first 24-48 h after surgery in patients. PONV is one of the most common causes of patient dissatisfaction after anesthesia, with reported incidences of 30% in all post-surgical patients and up to 80% in high-risk patients. In addition, PONV is regularly rated in preoperative surveys, as the anesthesia outcome the patient would most like to avoid. While suture dehiscence, aspiration of gastric contents, esophageal rupture, and other serious complications associated with PONV are rare, nausea and vomiting is still an unpleasant and all-too-common postoperative morbidity that can delay patient discharge from the post-anesthesia care unit and increase unanticipated hospital admissions in outpatients. There are many well-established risk factors for PONV which are classified in two classes: A) Patient related risk factors: Female gender is consistently the strongest risk factor for PONV, female patient are three times more likely than men to suffer from PONV. For adult patient, age is a statistically, though not clinically, relevant risk factor, with the incidence of PONV decreasing as patients age. For pediatric patients, however, age increases the risk of post-operative vomiting (POV), such that children older than 3 years have been shown to have an increased risk of POV compared with children younger than 3 years. Obesity is a strong risk factor for PONV: patients with body mass index (BMI) more than 30 have the double risk of PONV. Non-smoking status roughly doubles the patient's risk of PONV. The specific mechanism underlying smoking's protective effect is unknown ,but one of the most commonly believed theories is that polycyclic aromatic hydrocarbons in cigarette smoke induce cytochrome P450 enzyme which increase the metabolism of emetogenic volatile anesthetics. History of gastrointestinal disease as gastritis, gastric ulcer or duodenal ulcer increases the risk for PONV. History of motion sickness, Meniere's disease or previous PONV indicates a general susceptibility to PONV. B) Anesthesia related risk factors: The use of volatile anesthetics is associated with a two-fold increase in the risk of PONV, with risk increasing in a dose dependent manner. Intraoperative and postoperative opioid use increases the risk of PONV in a dose dependent manner by the mechanism of reducing muscle tone and peristaltic activity, thereby delaying gastric emptying, inducing distention, and triggering the vomiting reflex. The duration of anesthesia can help predict the patient's risk of PONV, since the duration of anesthesia describes the patient's exposure to emetogenic stimuli like volatile anesthetics and intraoperative opioids. Anti-emetic drugs used to treat PONV: The first line is classified into three classes: serotonin antagonists (e.g. ondansetron), corticosteroids (e.g. dexamethasone), and dopamine antagonists (e.g. droperidol) have similar efficacy against PONV, with a relative risk reduction of about 25%. Moreover, they act independently and when used in combination, have additiveeffects. Dexamethasone : it can be effective in preventing PONV in adults and children. Compared with other operative medications, dexamethasone has equal or even better efficacy in reducing the incidence of PONV and has the advantages of low cost and longer effectiveness as well. The mechanism of the antiemetic action of dexamethasone is still not clearly known. Glucocorticoids receptors are found in nucleus of the solitary tract, the raphe nucleus and the area postrema and all are associated with regulating nausea and vomiting. Dexamethasone may affect PONV by modulating neurotransmission or receptor density in these nuclei. Clinically, dexamethasone as a preventive drug against PONV has not caused fatal outcome; therefore, it is generally considered to be an effective and safe anti-emetic. Nevertheless, its use in this regard may lead to adverse effects, principally postoperative hyperglycemia and infection. The second line is Cyclizine: a histamine H1 antagonist given by mouth or parenterally for control of postoperative and drug-induced nausea and vomiting and in motion sickness. additionally, it has been used in management of vertigo in diseases affecting the vestibular apparatus. Although the mechanism by which cyclizine exerts its antiemetic and antivertigo effects has not been fully elucidated, its central anticholinergic properties are partially responsible. It also possesses anticholinergic, antihistaminic, central nervous system depressant and local anesthetic effects. cyclizine is metabolized to its N-demethylated derivative , norcyclizine , which has little antihistaminic activity compared to cyclizine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dexamethasone
    Arm Type
    Active Comparator
    Arm Title
    Cyclizine
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section
    Intervention Description
    The first group (Dexamethasone) will receive 8 mg IV dexamethasone within 1-2 minutes after the umbilical cord is clamped. The second group (Cyclizine) will receive 50 mg cyclizine within 1-2 minutes after the umbilical cord is clamped
    Primary Outcome Measure Information:
    Title
    Change in Post operative nausea and vomiting after intrathecal morphine by using PONV intensity scale.
    Description
    Nausea and vomiting were recorded as present or absent, All measurements and ratings were completed at the time when patients rated their PONV intensity. We also recorded factors known to be associated with the risk of developing PONV, including known risk factors for PONV.
    Time Frame
    Change in severity of nausea and vomiting 30 minutes , 3 hours, 6 hours after intervention
    Secondary Outcome Measure Information:
    Title
    Change in postoperative pain (assessed by VAS ).
    Description
    0 meaning no pain at all, and 10 described as the worst pain experienced.
    Time Frame
    Immediatly before and after intervention, 30 minutes after intervention, 3 hours after intervention, 6 hours

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Female 18 to 45 years old Parturient ASA I-II Full Term Exclusion Criteria: Women who has obstetric complications. Women with evidence of foetal compromise. Patients who have gastro-intestinal diseases. Administration of anti-emetic drugs within 24 hours before operation. Patients who have hyperemesis gravidarium
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mina Habib, Principal Investigator
    Phone
    +201092644868
    Email
    micheale14@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Cyclizine Vs. Dexamethasone for Nausea and Vomiting Following Intrathecal Morphine in Cases of Cesarean Section

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