search
Back to results

Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

Primary Purpose

Akathisia, Nausea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
metoclopramide 10 mg
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Akathisia focused on measuring metoclopramide, akathisia, nausea, vomiting, antiemetic, improvement of nausea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients 18 through 65 years of age and 50-90 kg of weight who presented to the ED with primary or secondary complaints of moderate to severe nausea who not use of commonly accepted antiemetic within the previous 24 hours were eligible for this study.
  • Their peripheral oxygen saturation level was 90% or over while respirating room air and free of any respiratory problems.

Exclusion Criteria:

  • Patients with mild symptoms of nausea
  • Altered mental status
  • Abnormal vital signs
  • Any known allergy to the metoclopramide
  • Previously enrolled in the study
  • Known renal failure or insufficiency
  • GIS hemorrhage, ileus and/or perforation
  • Women who were pregnant and lactating
  • Those with a history of epilepsy
  • Admitted to the ED due to acute psychiatric symptoms
  • Restless legs syndrome
  • Parkinson
  • Organic brain disease
  • Phaeochromocytoma
  • Patient with alcohol
  • Anticholinergic, sedative, hypnotic, trankilizan, digoxin, cimetidine, tetracycline and levo-dopa use
  • Presence of severe agitation akathisia can not be evaluated and uncooperative individuals.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    2 minutes bolus infusion

    15 minutes slow infusion

    Arm Description

    Outcomes

    Primary Outcome Measures

    akathisia and nausea scores

    Secondary Outcome Measures

    Full Information

    First Posted
    February 16, 2010
    Last Updated
    February 16, 2010
    Sponsor
    Pamukkale University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01069536
    Brief Title
    Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2007 (undefined)
    Primary Completion Date
    March 2007 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pamukkale University

    4. Oversight

    5. Study Description

    Brief Summary
    Study Objective: The purpose of this study is to compare the effects of metoclopramide administration in bolus versus slow infusion medications in ED patients complaining of nausea for the determination of the therapeutic effect and prevention of akathisia. Methods: This was a prospective, randomized, double-blind trial. The investigation was held between 01 March 2007 and 01 May 2008, in the Emergency Department of Pamukkale University Faculty of Medicine. The patients with moderate to severe nausea randomized and divided into two groups as for the previously planned administration type of drug. Ten mg metoclopramide was administered in one group with slow infusion (SIG) in 15 minutes, via 2 minutes bolus infusion (BIG) into the other group. Whole procedure was observed, akathisia and nausea scores and vital changes were recorded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Akathisia, Nausea
    Keywords
    metoclopramide, akathisia, nausea, vomiting, antiemetic, improvement of nausea

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    2 minutes bolus infusion
    Arm Type
    Active Comparator
    Arm Title
    15 minutes slow infusion
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    metoclopramide 10 mg
    Primary Outcome Measure Information:
    Title
    akathisia and nausea scores

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients 18 through 65 years of age and 50-90 kg of weight who presented to the ED with primary or secondary complaints of moderate to severe nausea who not use of commonly accepted antiemetic within the previous 24 hours were eligible for this study. Their peripheral oxygen saturation level was 90% or over while respirating room air and free of any respiratory problems. Exclusion Criteria: Patients with mild symptoms of nausea Altered mental status Abnormal vital signs Any known allergy to the metoclopramide Previously enrolled in the study Known renal failure or insufficiency GIS hemorrhage, ileus and/or perforation Women who were pregnant and lactating Those with a history of epilepsy Admitted to the ED due to acute psychiatric symptoms Restless legs syndrome Parkinson Organic brain disease Phaeochromocytoma Patient with alcohol Anticholinergic, sedative, hypnotic, trankilizan, digoxin, cimetidine, tetracycline and levo-dopa use Presence of severe agitation akathisia can not be evaluated and uncooperative individuals.

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

    We'll reach out to this number within 24 hrs