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
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
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
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
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
background
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Comp Granisetron Midazolam Comb in Lap Children
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