Comp Granisetron Midazolam Comb in Lap Children

Postoperative Nausea and Vomiting Clinical Trial

Official title:

Comparison of Granisetron Versus Midazolam and Thier Combination for Prophylaxis of Postoperative Nausea and Vomiting in Laparoscopic Surgery in Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03483350
• Other study ID #: Gmpl
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 13, 2018
• Last updated: March 28, 2018
• Start date: March 2018
• Est. completion date: January 2019

Study information

• Verified date: March 2018
• Source: Assiut University
• Contact: Zein ElAbideen Zareh Hassan Zareh Hassan, MD
• Phone: 01005187371
• Email: zein20002002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Granisetron
Ampoule
• Midazolam
Ampoule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramèr 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vomiting score	Have you vomited?; 0 - No, 1 - Once, 2 - Twice, 3 - Three or more time	for48hours(two day)
Secondary	Nausea score	Have you experienced feeling of nausea (an unsettled feeling in the stomach and slight urge to vomit); 0-No 1-Yes	for48hours(two day)