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

A Comparative Study of 1mg and 3 mg of Granisetron in the Prevention of Postoperative Nausea and Vomiting in Strabismus Ophthalmic Surgeries During General Anesthesia

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

Study Overview

• Status: Completed
• Conditions: 1mg Vs 3 mg of Granisetron
• Intervention / Treatment: Drug: Granisetron

Detailed Description

Postoperative nausea and vomiting (PONV) are common and distressing symptoms after surgery under general anesthesia. Despite advances in balanced anesthesia in recent decades, PONV can result in delayed discharge from the Post-Anesthesia Care Unit (PACU) recovery room, unexpected hospitalization and increase in medical costs.

The latest class of antiemetic for the prevention and treatment of PONV are the serotonin receptor antagonists (ondansetron, granisetron). These antiemetics do not have the negative effects of the older generations. Headache and dizziness are the main adverse effects of the serotonin receptor antagonists in the dosages used for PONV .

The FDA approved dose for the prevention of PONV is 1mg. This is based on a dose range study from Wilson and associates in which 0.1, 1.0, and 3.0 mg were associated with risk ratios for postoperative vomiting. The majority of studies on granisetron suggest that 3mg is superior to 1mg for the prevention of PONV, but those were published by a single center and there have been serious concerns about the validity of the data. In previous studies done on elective open abdominal surgery or vaginal hysterectomy but not in strabismus ophthalmic surgeries.

The ocular surgery associated with the highest incidence of PONV is strabismus surgery up to 85%. Vomiting after surgery is more likely 2-8hours than immediate postoperatively. Strabismus is a day case procedure and thus participants have to cope with emesis in the recovery room, or when traveling, or at home.

In this study, investigators compared two doses of granisetron in strabismus ophthalmic surgeries under general anesthesia

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Ahmed Abdalla Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Adult patients > 18 years old.

  • ASA I and II.
  • Patients scheduled for strabismus surgery.

Exclusion Criteria:

• • 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Granisetron 1 mg; Granisetron 1 mg: 105 patients received 1mg granisetron	Drug: Granisetron; 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; Other Names: Granisetron in the prevention of postoperative nausea and vomiting in strabismus ophthalmic surgeries during general anesthesia.
Active Comparator: Granisetron 3 mg; Granisetron 3 mg: 105 patients received 3mg granisetron	Drug: Granisetron; 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; Other Names: Granisetron in the prevention of postoperative nausea and vomiting in strabismus ophthalmic surgeries during general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of the optimal dose of granisetrone	Detection of the optimal dose of granisetrone/mg	Up to 24 hours
Detection of either attacks of nausea and vomiting occurred post operatively or not. •	Detection of either attacks of nausea and vomiting occurred post operatively or not	Post operatively over the first 24 hrs postoperative .
Blood Pressure	Blood Pressure measurment mmHg	Up to 24 hours
Heart Rate	Heart Rate measurment beat /minute	Up to 24 hours

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Mohamed, Ahmed A., M.D.; Mohamed Yousry Mohamed; Tamer Fayez Safan; Tamer Mohamed Khair; Islam Mohamed Sayed
• Investigators: Principal Investigator: Ahmed A Mohamed, M.D, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): May 9, 2021
• Study Completion (Actual): May 18, 2021

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Postoperative Complications; Signs and Symptoms, Digestive; Cranial Nerve Diseases; Ocular Motility Disorders; Nausea; Vomiting; Strabismus; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Serotonin Agents; Serotonin Antagonists; Granisetron
• Other Study ID Numbers: MS-380-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Till Submission

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No