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| Name | Class |
|---|---|
| Mohamed Yousry Mohamed | UNKNOWN |
| Tamer Fayez Safan | UNKNOWN |
| Tamer Mohamed Khair | UNKNOWN |
| Mohamed, Ahmed A., M.D. |
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Investigators aim to determine the optimal dose of granisetron in strabismus ophthalmic surgeries under general anesthesia to prevent postoperative nausea and vomiting
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granisetron 1 mg | Active Comparator | Granisetron 1 mg: 105 patients received 1mg granisetron |
|
| Granisetron 3 mg | Active Comparator | Granisetron 3 mg: 105 patients received 3mg granisetron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of the optimal dose of granisetrone | Detection of the optimal dose of granisetrone/mg | Up to 24 hours |
| Detection of either attacks of nausea and vomiting occurred post operatively or not. • |
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Inclusion Criteria:
• Adult patients > 18 years old.
Exclusion Criteria:
• ASA class > II.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed A Mohamed, M.D | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed Abdalla Mohamed | Cairo | 11451 | Egypt |
Till Submission
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| INDIV |
| Islam Mohamed Sayed | UNKNOWN |
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.
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Computer-generated sequence will be used for randomization and opaque envelopes will be used for concealment
|
|
Detection of either attacks of nausea and vomiting occurred post operatively or not
| Post operatively over the first 24 hrs postoperative . |
| Blood Pressure | Blood Pressure measurment mmHg | Up to 24 hours |
| Heart Rate | Heart Rate measurment beat /minute | Up to 24 hours |
| ID | Term |
|---|---|
| D017829 | Granisetron |
| ID | Term |
|---|---|
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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