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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04918862
• Collaborator: Mohamed Yousry Mohamed (Other), Tamer Fayez Safan (Other), Tamer Mohamed Khair (Other), Mohamed, Ahmed A., M.D. (Other), Islam Mohamed Sayed (Other)
• Enrollment: 210
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.3
• Patients Per Site Per Month: 49.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
1mg Vs 3 mg of Granisetron	Drug: Granisetron	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Single (Participant)
• Masking Description: Computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Jan 8, 2021
• Actual Primary Completion Date: May 9, 2021
• Actual Study Completion Date: May 18, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative [Up to 24 hours]

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

Secondary Outcome Measures

1. Detection of the optimal dose of granisetrone [Up to 24 hours]

   Detection of the optimal dose of granisetrone/mg

2. Detection of either attacks of nausea and vomiting occurred post operatively or not. • [Post operatively over the first 24 hrs postoperative .]

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

3. Blood Pressure [Up to 24 hours]

   Blood Pressure measurment mmHg

4. Heart Rate [Up to 24 hours]

   Heart Rate measurment beat /minute

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abdalla Mohamed	Cairo		Egypt	11451

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Ahmed A Mohamed, M.D, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Abdalla, Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University, Cairo University
• ClinicalTrials.gov Identifier: NCT04918862
• Other Study ID Numbers: MS-380-2020
• First Posted: Jun 9, 2021
• Last Update Posted: Jun 21, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Strabismus; Vomiting; Postoperative Nausea and Vomiting; Granisetron

Study Results

No Results Posted as of Jun 21, 2021