Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients

Study Overview
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Brief Summary
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compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients and in normal weight patients.

Detailed Description
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compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients. compare the effectiveness of dexamethasone given in 4 mg and 8 mg doses in obese patients with 4 mg doses of dexamethasone in normal weight patients. 4 mg iv dexamethasone will be administered to normal weight patients at induction of anesthesia. This group will be classified as the control group. In obese patients (BMI>30 kg/m2), one group will receive 4 mg dexamethasone and other group will receive 8 mg dexamethasone at induction. Patients will receive general anesthesia with volatile anesthetics and tramadol will be administered IV at the end of surgery. Postoperative nausea and vomiting, postoperative pain, blood glucose, wound infection, time to oral intake, hospital stay will be compared.

Official Title
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Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Dexamethasone 4 mg IV-control
* Drug: Dexamethasone 4 mg IV
* Drug: Dexamethasone 8 mg IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High risk patients for postoperative nausea and vomiting: Female No smoking BMI =18.5-24.9 for control group BMI >30 for other groups undergo laparoscopic cholecystectomy Exclusion Criteria: Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>patients with BMI=18.5-24.9 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis. | Drug: Dexamethasone 4 mg IV-control<br>* dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to normal weight patients.<br>|
| Active Comparator: 4 mg<br>patients with BMI>30 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis. | Drug: Dexamethasone 4 mg IV<br>* dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients<br>|
| Active Comparator: 8 mg<br>patients with BMI>30 kg/m2 will be received 8 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis. | Drug: Dexamethasone 8 mg IV<br>* dexamethasone 8 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative nausea and vomiting (PONV) | The primary outcome is the overall incidence of PONV during the ﬁrst 24 h, deﬁned as any episode of vomiting or nausea.Nausea will be measured using an 11-point verbal rating scale (VRS) running from 0 (no nausea) to 10 (the worst nausea imaginable). We will deﬁne severe PONV as nausea with a score of at least 4 on the VRS, or vomiting. | PONV scores wİll be record during the ﬁrst 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain: 11-point VRS | Pain intensity will be measured using a simple 11-point VRS running from 0 (no pain) to 10 (unbearable pain), at rest and on mobilisation (asking the patient to cough). | Pain will be assessed during the ﬁrst 24 hours | 
| oral intake | patients will be asked first oral fluid intake time charge criteria. | during the ﬁrst 24 hours | 
| blood glucose | Fingerprick capillary blood glucose concentrations will be measured | at 6 and 10 hours after administration of dexamethasone | 
| Length of Hospital Stay | the time will be recorded when patients are discharged home | during the ﬁrst 24 hours | 
| wound infection | Patients will be telephone on the 30th postoperative day and questioned in terms of wound infection | postoperative 30th day |