Comp Granisetron Midazolam Comb in Lap Children

NCT03483350 | Unknown Phase 3

• 1 other identifier: Gmpl
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Vomiting score

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

  for48hours(two day)

Secondary Outcomes (1)

• Nausea score

  for48hours(two day)

Study Arms (3)

1- 1st group

EXPERIMENTAL

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

2- 2nd

EXPERIMENTAL

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

3- 3rd group

EXPERIMENTAL

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; Drug: Midazolam

Interventions

Granisetron DRUG

Ampoule

1- 1st group; 3- 3rd group

Midazolam DRUG

Ampoule

2- 2nd; 3- 3rd group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 12818945 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Granisetron; Midazolam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzodiazepines; Benzazepines

Central Study Contacts

Zein ElAbideen Zareh Hassan Zareh Hassan, MD

CONTACT

01005187371; zein20002002@yahoo.com

Dr.Wesam Nashat Ali, MD

CONTACT

01002416772; wesamnashat12015@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesiology Assiut University

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 30, 2018
• Study Start: March 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: January 1, 2019
• Last Updated: March 30, 2018

Record last verified: 2018-03