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Intrathecal Atropine vs IV Metoclopramide for Nausea & Vomiting During CS

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ClinicalTrials.gov Identifier: NCT03932578
Recruitment Status : Completed
First Posted : April 30, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Mansoura University

Brief Summary:
The aim of this study is to evaluate the prophylactic use of low dose atropine and comparing it to metoclopramide for reducing intraoperative nausea and vomiting during cesarean section under spinal anesthesia

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: Atropine sulfate Drug: Metoclopramide Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Intrathecal Atropine Versus Intravenous Metoclopramide for Prevention of Nausea and Vomiting During Caesarian Section Under Spinal Anesthesia
Actual Study Start Date : May 5, 2019
Actual Primary Completion Date : August 28, 2019
Actual Study Completion Date : August 28, 2019

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Arm Intervention/treatment
Active Comparator: Atropine group
Patients will receive IV study solution which is 2 ml saline 0.9% as a placebo + intrathecal study solution which is a premised solution of 2.5 ml of 0.5% hyperbaric bupivacaine, 25 μg fentanyl and 100 μg of a 1 mg/ml preservative-free atropine sulfate solution
Drug: Atropine sulfate
Patients will receive intrathecal 100 μg of a 1 mg/ml preservative-free atropine sulfate solution

Active Comparator: Metoclopramide group
Patients in will receive IV study solution which is metoclopramide 10 mg in 2 ml + intrathecal study solution which is a premised solution of 2.5 ml of 0.5% hyperbaric bupivacaine, 25 μg fentanyl and 100 μg of preservative-free saline 0.9% as a placebo
Drug: Metoclopramide
Patients will receive IV metoclopramide 10 mg in 2 ml




Primary Outcome Measures :
  1. Intraoperative nausea and vomiting (IONV) [ Time Frame: During CS ]
    Spontaneous reporting of IONV by patients, as well as any clinical manifestations (retching or vomiting) and any requests for antiemetic medication will be considered as episodes of NV

  2. Postoperative nausea and vomiting (PONV) [ Time Frame: 12 hours after CS ]
    Spontaneous reporting of PONV by patients during scheduled interviews, as well as any clinical manifestations (retching or vomiting) and any requests for antiemetic medication will be considered as episodes of NV


Secondary Outcome Measures :
  1. Time of requiring antiemetics [ Time Frame: Until 12 hours postoperatively ]
    The time of the first request for antiemetic drugs

  2. Number of requiring antiemetics [ Time Frame: Until 12 hours postoperatively ]
    The number of requests for antiemetic drugs



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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:

  • Patients with ASA physical status class I or II; indications for CS other than fetal or maternal pathology and surgery scheduled for within 4 days of physiological term will be included in this study

Exclusion Criteria:

  • Height < 150 or > 180 cm
  • Body mass index (BMI) >35 kg/m2
  • Active labor or emergency CS
  • Emesis gravidarum
  • Multifetal pregnancy
  • Fetal distress
  • Associated medical problem with pregnancy (as hypertension, diabetes mellitus, hepatic impairment or renal impairment)
  • Obstetric problem (as placenta previa or placental abruption)
  • Contraindication for central neuraxial block
  • History of adverse reaction to any study medication
  • History of antiemetic drug use
  • Refusal to undergo regional 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): NCT03932578


Locations
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Egypt
Mansoura University Hospital
Mansoura, Dakahlia, Egypt, 35111
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Tamer Elmetwally, MD Mansoura University
Study Chair: Mohamed S Abdelhafez, MD Mansoura University

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT03932578     History of Changes
Other Study ID Numbers: MSA10
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After publication and forever
Access Criteria: Contact to corresponding author

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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 Mansoura University:
Cesarean section
Nausea and vomiting
Spinal Anesthesia
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Atropine
Metoclopramide
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents