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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

Primary Purpose

1mg Vs 3 mg of Granisetron

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Granisetron
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for 1mg Vs 3 mg of Granisetron

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Ahmed Abdalla Mohamed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Granisetron 1 mg

Granisetron 3 mg

Arm Description

Granisetron 1 mg: 105 patients received 1mg granisetron

Granisetron 3 mg: 105 patients received 3mg granisetron

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Detection of the optimal dose of granisetrone
Detection of the optimal dose of granisetrone/mg
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
Blood Pressure
Blood Pressure measurment mmHg
Heart Rate
Heart Rate measurment beat /minute

Full Information

First Posted
May 20, 2021
Last Updated
June 16, 2021
Sponsor
Cairo University
Collaborators
Mohamed Yousry Mohamed, Tamer Fayez Safan, Tamer Mohamed Khair, Mohamed, Ahmed A., M.D., Islam Mohamed Sayed
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1. Study Identification

Unique Protocol Identification Number
NCT04918862
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 8, 2021 (Actual)
Primary Completion Date
May 9, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Mohamed Yousry Mohamed, Tamer Fayez Safan, Tamer Mohamed Khair, Mohamed, Ahmed A., M.D., Islam Mohamed Sayed

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
1mg Vs 3 mg of Granisetron

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Granisetron 1 mg
Arm Type
Active Comparator
Arm Description
Granisetron 1 mg: 105 patients received 1mg granisetron
Arm Title
Granisetron 3 mg
Arm Type
Active Comparator
Arm Description
Granisetron 3 mg: 105 patients received 3mg granisetron
Intervention Type
Drug
Intervention Name(s)
Granisetron
Other Intervention Name(s)
Granisetron in the prevention of postoperative nausea and vomiting in strabismus ophthalmic surgeries during general anesthesia.
Intervention Description
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
Primary Outcome Measure Information:
Title
The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative
Description
The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Detection of the optimal dose of granisetrone
Description
Detection of the optimal dose of granisetrone/mg
Time Frame
Up to 24 hours
Title
Detection of either attacks of nausea and vomiting occurred post operatively or not. •
Description
Detection of either attacks of nausea and vomiting occurred post operatively or not
Time Frame
Post operatively over the first 24 hrs postoperative .
Title
Blood Pressure
Description
Blood Pressure measurment mmHg
Time Frame
Up to 24 hours
Title
Heart Rate
Description
Heart Rate measurment beat /minute
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Mohamed, M.D
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Abdalla Mohamed
City
Cairo
ZIP/Postal Code
11451
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Till Submission

Learn more about this trial

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

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