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Completed

NCT Number: 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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Granisetron

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

Other names: Granisetron in the prevention of postoperative nausea and vomiting in strabismus ophthalmic surgeries during general anesthesia.

Primary outcomes

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

    Time frame: Up to 24 hours

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

Secondary outcomes

  1. Detection of the optimal dose of granisetrone

    Time frame: 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. •

    Time frame: Post operatively over the first 24 hrs postoperative .

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

  3. Blood Pressure

    Time frame: Up to 24 hours

    Blood Pressure measurment mmHg

  4. Heart Rate

    Time frame: Up to 24 hours

    Heart Rate measurment beat /minute

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2021
Registry last updated
Jun 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.