Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries

Study Overview
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Brief Summary
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To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic gynacological surgeries.

Detailed Description
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Postoperative nausea and vomiting (PONV) is frequently encountered in the surgical recovery room. Laparoscopic surgery is one important risk factor for increased incidence of PONV. Gabapentin, an anticonvulsant with known postoperative analgesic properties, has shown some activity against PONV. Results from clinical trials evaluating the anti-emetic efficacy of gabapentin are conflicting. Aprepitant, a neurokinin-1 (NK1) receptor antagonist, blockades the central effects of substance P. Substance P is a neurotransmitter found in central areas associated with emesis such as the dorsal vagal complex and area postrema.

Official Title
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Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: dexamethasone
* Drug: Gabapentin
* Drug: Aprepitant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • ASA physical status I and II aged between 18 and 45 yrs. They undergo Laproscopic gynacological surgeries under general anesthesia. Exclusion Criteria: Central or peripheral neurological pathologies. History of drug abuse, chronic pain, or psychiatric disorders. Pregnant women Patients who took sedatives, antiemetics, or antipruritics within 24 hrs of operation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexamethasone<br>intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia; | Drug: dexamethasone<br>* dexamethasone 8 mg iv 2 minutes before induction of anesthesia<br>* Other names: Decadron;|
| Active Comparator: gapabentin<br>oral gabapentin 600 mg 1 hour before induction of anesthesia | Drug: dexamethasone<br>* dexamethasone 8 mg iv 2 minutes before induction of anesthesia<br>* Other names: Decadron;Drug: Gabapentin<br>* oral gabapentin 600 mg 1 hour before induction of anesthesia<br>* Other names: Neurontin;|
| Active Comparator: Aprepitant<br>aprepitan 80mg 1 hour before induction of anesthesia. | Drug: dexamethasone<br>* dexamethasone 8 mg iv 2 minutes before induction of anesthesia<br>* Other names: Decadron;Drug: Aprepitant<br>* oral aprepitan 80mg 1 hour before induction of anesthesia.<br>* Other names: Emend;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence (%) of postoperative nausea and vomiting | The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU. | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non invasive blood pressure | Noninvasive blood pressure measured immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery | intra-operative from induction of general anesthesia till end of surgery. | 
| heart rate | heart rate recorded immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery | Intra-operative from induction of anesthesia till end of surgery. | 
| side effects | Side effects of given drugs will be treated and recorded | 24 h postoperative. |