Comp Granisetron Midazolam Comb in Lap Children

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03483350

Collaborator

(none)

Enrollment

Arms

10.1

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: Granisetron Drug: Midazolam	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Vomiting score [for48hours(two day)]
Have you vomited? 0 - No, 1 - Once, 2 - Twice, 3 - Three or more time

Secondary Outcome Measures

Nausea score [for48hours(two day)]
Have you experienced feeling of nausea (an unsettled feeling in the stomach and slight urge to vomit) 0-No 1-Yes

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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