Ahmed Abdalla Mohamed
Cairo, 11451, Egypt
NCT Number: NCT04918862
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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Notify Me18 year–60 year
All sexes
Interventional
Phase 3
Cairo, 11451, Egypt
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 24 hours
The percent of patients with total control of nausea and vomiting over the first 24 hrs postoperative
Time frame: Up to 24 hours
Detection of the optimal dose of granisetrone/mg
Time frame: Post operatively over the first 24 hrs postoperative .
Detection of either attacks of nausea and vomiting occurred post operatively or not
Time frame: Up to 24 hours
Blood Pressure measurment mmHg
Time frame: Up to 24 hours
Heart Rate measurment beat /minute
Cairo University
Other
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
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