Clinical trial NCT04918862: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 1mg Vs 3 mg of Granisetron
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Mohamed Yousry Mohamed
name: Tamer Fayez Safan
name: Tamer Mohamed Khair
name: Mohamed, Ahmed A., M.D.
name: Islam Mohamed Sayed
First posted: 2021-06-09
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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

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

Eligibility criteria: 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).

Primary outcomes:
measure: The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Detection of the optimal dose of granisetrone
timeFrame: Up to 24 hours
measure: Detection of either attacks of nausea and vomiting occurred post operatively or not. •
timeFrame: Post operatively over the first 24 hrs postoperative .
measure: Blood Pressure
timeFrame: Up to 24 hours
measure: Heart Rate
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
Study officials:
affiliation: Cairo University
name: Ahmed A Mohamed, M.D
role: PRINCIPAL_INVESTIGATOR
References: