A COMPARATIVE STUDY BETWEEN 1MG AND 3 MG OF GRANISETRON IN THE PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING IN STRABISMUS OPHTHALMIC SURGERIES DURING GENERAL ANESTHESIA

NCT04918862 | Completed Phase 3 DMC

• 1 other identifier: MS-380-2020
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators aim to determine the optimal dose of granisetron in strabismus ophthalmic surgeries under general anesthesia to prevent postoperative nausea and vomiting

Conditions

1mg Vs 3 mg of Granisetron

Outcome Measures

Primary Outcomes (1)

• The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative

  The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative

  Up to 24 hours

Secondary Outcomes (4)

• Detection of the optimal dose of granisetrone

  Up to 24 hours

• Detection of either attacks of nausea and vomiting occurred post operatively or not. •

  Post operatively over the first 24 hrs postoperative .

• Blood Pressure

  Up to 24 hours

• Heart Rate

  Up to 24 hours

Study Arms (2)

Granisetron 1 mg

ACTIVE COMPARATOR

Granisetron 1 mg: 105 patients received 1mg granisetron

Drug: Granisetron

Granisetron 3 mg

ACTIVE COMPARATOR

Granisetron 3 mg: 105 patients received 3mg granisetron

Drug: Granisetron

Interventions

Granisetron DRUG

210 patients were enrolled, divided into two groups \[Granisetron 1 mg: 105 patients received 1mg granisetron, Granisetron 3 mg: 105 patients received 3mg granisetron\]. The two groups were compared in demographic characteristics (age, gender, weight, and height), hemodynamic parameters (MAP and HR), and duration of surgery

Also known as: Granisetron in the prevention of postoperative nausea and vomiting in strabismus ophthalmic surgeries during general anesthesia.

Granisetron 1 mg; Granisetron 3 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients \> 18 years old.
• ASA I and II.
• Patients scheduled for strabismus surgery.

You may not qualify if:

• ASA class \> II.
• Patients with known hypersensitivity or contraindication to any of the study medications.
• Patients who had chronic nausea and vomiting or experienced retching, vomiting, moderate to severe nausea in the preoperative day.
• Patients who had received an antiemetic drug in the preoperative day.
• Patients with a body mass index ≥36.
• Pregnant or breast feeding female patient.
• Patients with gastrointestinal diseases.
• Patients with a history of motion sickness, diabetes mellitus, and GIT pathology (gastritis, hematemesis, peptic ulcer).

Sponsors & Collaborators

• Cairo University: lead
• Mohamed Yousry Mohamed: collaborator
• Tamer Fayez Safan: collaborator
• Tamer Mohamed Khair: collaborator
• Mohamed, Ahmed A., M.D.: collaborator
• Islam Mohamed Sayed: collaborator

Study Sites (1)

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Granisetron

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

Study Officials

• Ahmed A Mohamed, M.D

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Model Details: 210 patients were recruited and allocated randomly to receive either granisetron 1.0mg (n =105) or granisetron 3.0mg (n =105). The two groups were compared regarding: demographic data of the patients, hemodynamic parameters including mean arterial pressure and heart rate and percentage of patients with no complain of postoperative nausea and vomiting at first 24 hours.

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 9, 2021
• Study Start: January 8, 2021
• Primary Completion: May 9, 2021
• Study Completion: May 18, 2021
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

EG (1)