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

NCT ID: NCT04918862

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-08
• Study Completion Date: 2021-05-18

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

Conditions

1mg Vs 3 mg of Granisetron

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Granisetron 1 mg

Granisetron 1 mg: 105 patients received 1mg granisetron

Group Type: ACTIVE_COMPARATOR

Granisetron

Intervention Type: 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

Granisetron 3 mg

Granisetron 3 mg: 105 patients received 3mg granisetron

Group Type: ACTIVE_COMPARATOR

Granisetron

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Granisetron in the prevention of postoperative nausea and vomiting in strabismus ophthalmic surgeries during 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mohamed Yousry Mohamed

UNKNOWN

Sponsor Role: collaborator

Tamer Fayez Safan

UNKNOWN

Sponsor Role: collaborator

Tamer Mohamed Khair

UNKNOWN

Sponsor Role: collaborator

Mohamed, Ahmed A., M.D.

INDIV

Sponsor Role: collaborator

Islam Mohamed Sayed

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdalla

Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed A Mohamed, M.D

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Ahmed Abdalla Mohamed

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-380-2020

Identifier Type: -

Identifier Source: org_study_id