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
Condition: 1mg Vs 3 mg of Granisetron
MeSH terms: Strabismus; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 3

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
    

Intervention name(s): Granisetron
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Granisetron in the prevention of postoperative nausea and vomiting in strabismus ophthalmic surgeries during general anesthesia.
Intervention MeSH terms: Granisetron
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.
Masking: Single (Participant)
Primary purpose: Prevention