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Comp Granisetron Midazolam Comb in Lap Children

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ClinicalTrials.gov Identifier: NCT03483350
Recruitment Status : Not yet recruiting
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Wesam Nashat Ali, Assiut University

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.


Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Granisetron Drug: Midazolam Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Granisetron Versus Midazolam and Thier Combination for Prophylaxis of Postoperative Nausea and Vomiting in Laparoscopic Surgery in Children
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1- 1st group
1- 1st group will include 30 patients will receive intravenous granisetron 10 μg/kg after induction of anesthesia and before start of surgery
Drug: Granisetron
Ampoule

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

Experimental: 3- 3rd group
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
Drug: Granisetron
Ampoule

Drug: Midazolam
Ampoule




Primary Outcome Measures :
  1. Vomiting score [ Time Frame: for48hours(two day) ]

    Have you vomited?

    0 - No, 1 - Once, 2 - Twice, 3 - Three or more time



Secondary Outcome Measures :
  1. Nausea score [ Time Frame: for48hours(two day) ]

    Have you experienced feeling of nausea (an unsettled feeling in the stomach and slight urge to vomit)

    0-No 1-Yes




Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03483350


Contacts
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Contact: Zein ElAbideen Zareh Hassan Zareh Hassan, MD 01005187371 zein20002002@yahoo.com
Contact: Dr.Wesam Nashat Ali, MD 01002416772 wesamnashat12015@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Wesam Nashat Ali, Lecturer of anesthesiology Assiut University, Assiut University
ClinicalTrials.gov Identifier: NCT03483350     History of Changes
Other Study ID Numbers: Gmpl
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Midazolam
Granisetron
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents