Postoperative Nausea and Vomiting
Conditions
Brief summary
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
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.
Interventions
DRUGDexamethasone 4 mg IV-control
dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to normal weight patients.
DRUGDexamethasone 4 mg IV
dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
DRUGDexamethasone 8 mg IV
dexamethasone 8 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
Sponsors
Diskapi Yildirim Beyazit Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative nausea and vomiting (PONV) | PONV scores wİll be record during the first 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain: 11-point VRS | Pain will be assessed during the first 24 hours | 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). |
| oral intake | during the first 24 hours | patients will be asked first oral fluid intake time charge criteria. |
| blood glucose | at 6 and 10 hours after administration of dexamethasone | Fingerprick capillary blood glucose concentrations will be measured |
| Length of Hospital Stay | during the first 24 hours | the time will be recorded when patients are discharged home |
| wound infection | postoperative 30th day | Patients will be telephone on the 30th postoperative day and questioned in terms of wound infection |
Countries
Turkey (Türkiye)
Contacts
Primary ContactBahar SAKIZCI UYAR
Outcome results
None listed