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The incidence of postoperative nausea and vomiting (PONV) after general anesthesia is up to 30% when inhalational anesthetics are used with no prophylaxis. This makes PONV one of the most common complaints following surgery under general anesthesia, together with postoperative pain.
This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups:
Group 1: Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia.
Group 2: Patients will receive 10 mg metoclopramide before induction of general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual therapy | Experimental | Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia |
|
| Monotherapy | Active Comparator | Patients will receive 10 mg metoclopramide before induction of general anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual therapy | Other | combination of 10 mg metoclopramide with 4 mg ondansetron |
| |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative nausea and vomiting | The Primary aim of this study is to compare the effect of prophylactic combination therapy (dual therapy) metoclopramide-ondansetron vs. ondansetron monotherapy for the treatment of postoperative nausea and vomiting after laparoscopic cholecystectomy. This will be assessed through a questionnaire with yes or no question where yes indicates the presence of nausea or vomiting and no indicating the absence of nausea or vomiting. | 36 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon satisfaction | Assess surgeon satisfaction with anesthesia using a questionnaire named "the Surgeon Satisfaction with Anesthesia Services Scales". The questionnaire uses a scale: 1-strongly disagree, 2- disagree, 3- agree, 4- strongly agree | 36 hours postoperatively |
| Patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoher Naja, MD | Makassed General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Makassed General Hospital | Beirut | Lebanon |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D000080903 | Dual Anti-Platelet Therapy |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000758 | Anesthesia |
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| Monotherapy |
| Other |
10 mg metoclopramide |
|
| General anesthesia | Other | Induction of general anesthesia will be performed followed by endotracheal intubation. |
|
Assess patient satisfaction with anesthesia using the Iowa Satisfaction Anesthesia scale which measures patient satisfaction through a scale: strongly disagree, disagree, undecided, agree and strongly agree |
| 36 hours postoperatively |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D000760 |
| Anesthesia and Analgesia |