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Comp Granisetron Midazolam Comb in Lap Children

Primary Purpose

Postoperative Nausea and Vomiting

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Granisetron
Midazolam
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • This study will include children, scheduled for elective Laparoscopic surgery
  • Age 4-12 years
  • ASA I or II

Exclusion Criteria: Patients will be excluded who meet these criteria

  • Patient refusal
  • Any contraindication of laparoscopic surgery;as personal history of seizures, peripheral neurologic diseases, cardiac arrhythmias, liver disease, renal dysfunction and cardiac conduction abnormalises
  • Known allergy to the drugs included in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    1- 1st group

    2- 2nd

    3- 3rd group

    Arm Description

    1- 1st group will include 30 patients will receive intravenous granisetron 10 μg/kg after induction of anesthesia and before start of surgery

    2- 2nd group will include 30 patients will receive intravenous midazolam 50 μg/kg after induction of anesthesia and before start of surgery

    3- 3rd group will include 30 patients will receive combination intravenous granisetron 5 μg/kg with midazolam 25 μg/kg after induction of anesthesia and before start of surgery

    Outcomes

    Primary Outcome Measures

    Vomiting score
    Have you vomited? 0 - No, 1 - Once, 2 - Twice, 3 - Three or more time

    Secondary Outcome Measures

    Nausea score
    Have you experienced feeling of nausea (an unsettled feeling in the stomach and slight urge to vomit) 0-No 1-Yes

    Full Information

    First Posted
    February 13, 2018
    Last Updated
    March 28, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03483350
    Brief Title
    Comp Granisetron Midazolam Comb in Lap Children
    Official Title
    Comparison of Granisetron Versus Midazolam and Thier Combination for Prophylaxis of Postoperative Nausea and Vomiting in Laparoscopic Surgery in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    January 2019 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Postoperative nausea and vomiting (PONV) is one of the most common complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double those of adult patients. The physiology of PONV is complex and not perfectly understood. According to our current model, the brain structures involved in the pathophysiology of vomiting are distributed throughout the medulla oblongata of the brainstem, not centralized in an anatomically defined 'vomiting centre. Such structures include the chemoreceptor trigger zone (CRTZ), located at the caudal end of the fourth ventricle in the area postrema, and the nucleus tractus solitarius (NTS), located in the area postrema and lower pons.
    Detailed Description
    Postoperative nausea and vomiting (PONV) is one of the most common complications of general anesthesia in pediatrics. Pediatric rates of nausea and vomiting are approximately double those of adult patients. The physiology of PONV is complex and not perfectly understood. According to our current model, the brain structures involved in the pathophysiology of vomiting are distributed throughout the medulla oblongata of the brainstem, not centralized in an anatomically defined 'vomiting centre. Such structures include the chemoreceptor trigger zone (CRTZ), located at the caudal end of the fourth ventricle in the area postrema, and the nucleus tractus solitarius (NTS), located in the area postrema and lower pons. The CRTZ receives input from vagal afferents in the gastrointestinal tract, and it can also detect emetogenic toxins, metabolites, and drugs circulating in the blood and cerebrospinal fluid due to its lack of the bloodbrain barrier. Multiple neurotransmitter pathways are implicated in the physiology of nausea and vomiting. Enterochromaffin cells in the gastrointestinal tract release serotonin, and the vagus nerve communicates with the CRTZ via 5-HT3 receptors. The CRTZ communicates with the NTS primarily via dopamine-2 (D2) receptors. PONV may increase hospital expenditure by prolongation of hospital stay, and management of vomiting related complications such as dehydration, electrolyte disturbances, and pulmonary aspiration. Pediatric laparoscopic surgery is commonly associated with higher incidence of PONV. Mixtures of different classes of antiemetics have been used successfully to decrease the incidence of PONV but there was no agreement on the optimal combination. Granisetron a newer 5-HT3 antagonist has stronger receptor binding and has been found to be more potent and longer acting as antiemetic for preventing postoperative nausea and vomiting following laparoscopic surgery. Midazolam is commonly used as a premedication to relief anxiety. Midazolam given intravenously before the end of surgery was effective in decreasing the incidence of PONV. sub-hypnotic dose of midazolam was suggested that have a role in the management of PONV.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Nausea and Vomiting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1- 1st group
    Arm Type
    Experimental
    Arm Description
    1- 1st group will include 30 patients will receive intravenous granisetron 10 μg/kg after induction of anesthesia and before start of surgery
    Arm Title
    2- 2nd
    Arm Type
    Experimental
    Arm Description
    2- 2nd group will include 30 patients will receive intravenous midazolam 50 μg/kg after induction of anesthesia and before start of surgery
    Arm Title
    3- 3rd group
    Arm Type
    Experimental
    Arm Description
    3- 3rd group will include 30 patients will receive combination intravenous granisetron 5 μg/kg with midazolam 25 μg/kg after induction of anesthesia and before start of surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Granisetron
    Intervention Description
    Ampoule
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Intervention Description
    Ampoule
    Primary Outcome Measure Information:
    Title
    Vomiting score
    Description
    Have you vomited? 0 - No, 1 - Once, 2 - Twice, 3 - Three or more time
    Time Frame
    for48hours(two day)
    Secondary Outcome Measure Information:
    Title
    Nausea score
    Description
    Have you experienced feeling of nausea (an unsettled feeling in the stomach and slight urge to vomit) 0-No 1-Yes
    Time Frame
    for48hours(two day)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: This study will include children, scheduled for elective Laparoscopic surgery Age 4-12 years ASA I or II Exclusion Criteria: Patients will be excluded who meet these criteria Patient refusal Any contraindication of laparoscopic surgery;as personal history of seizures, peripheral neurologic diseases, cardiac arrhythmias, liver disease, renal dysfunction and cardiac conduction abnormalises Known allergy to the drugs included in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zein ElAbideen Zareh Hassan Zareh Hassan, MD
    Phone
    01005187371
    Email
    zein20002002@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dr.Wesam Nashat Ali, MD
    Phone
    01002416772
    Email
    wesamnashat12015@yahoo.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12818945
    Citation
    Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.
    Results Reference
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    Comp Granisetron Midazolam Comb in Lap Children

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