Dexamethasone With Super-hydration for Prevention of Postoperative Nausea and Vomiting

Study Overview
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Brief Summary
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Postoperative nausea and vomiting (PONV) are the most common and distressing side effects following Laparoscopic cholecystectomy

Detailed Description
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In the operating room, standard monitors included electrocardiogram, noninvasive arterial blood pressure, arterial oxygen saturation, and end-tidal carbon dioxide were connected. All patients received standardized anesthetic technique. At the end of surgery, gastric contents were suctioned via an orogastric tube before extubation. Atropine and neostigmine (1/2.5 mg) was given slowly I.V. to antagonize the residual neuromuscular block. Then, the trachea was extubated. Then, patients were transferred to the post-anesthesia care unit in a stable condition. Patients were allowed to drink liquids as soon as requested.

Official Title
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Dexamethasone Alone Versus in Combination With Intra-operative Super-hydration for Prevention of Postoperative Nausea and Vomiting in Female Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Clinical Trial

Conditions
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Nausea and Vomiting, Postoperative

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: 10 ml/kg Ringer's lactate
* Drug: 30 ml/kg Ringer's lactate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I or II aged Elective laparoscopic cholecystectomy Exclusion Criteria: Steroids use within the last 3 days before surgery Antiemetic use within the last 3 days before surgery Opioids use within the last 3 days before surgery. Patients with liver, cardiac or renal diseases Patients with Pregnancy Patients with Bmi ˃ 30kg/m2 Patients with Delayed wound healing Open surgery

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone Group<br>I.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution. | Drug: Dexamethasone<br>* 5 mg I.V. Dexamethasone just before induction<br>* Other names: Decadron;Drug: 10 ml/kg Ringer's lactate<br>* Intra-operative 10 ml/kg Ringer's lactate solution .<br>* Other names: Normal hydration;|
| Active Comparator: Dexamethasone and super-hydration Group<br>I.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution | Drug: Dexamethasone<br>* 5 mg I.V. Dexamethasone just before induction<br>* Other names: Decadron;Drug: 30 ml/kg Ringer's lactate<br>* Intra-operative 30 ml/kg Ringer's lactate solution .<br>* Other names: super-hydration;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Nausea and Vomiting (PONV) | A nurse, who was unaware about the groups to which the patient belonged, evaluated patients at 0, 6, and 24 h after surgery for any symptoms of nausea, retching, or vomiting. PONV is classified as early, if occurring up to 6h after surgery, or late, if occurring between 6 h up to 24 postoperatively. A Verbal Descriptive Scale (VDS), was used to assess the severity of PONV: no PONV (grade 0), mild PONV (grade 1), moderate PONV (grade 2) and severe PONV (grade 3) | Within the first 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of patients who had nausea, vomiting or retching | Total number of patients who had nausea, vomiting or retching (number) | Within the first 24 hours postoperatively | 
| Antiemetic usage | Total amount of ondansetron consumption (mg) | Within the first 24 hours postoperatively | 
| Pain Score | A visual analogue scale (appropriate score) | Within the first 24 hours postoperatively | 
| Total analgesic consumption | I.V Pethidine (mg) | Within the first 24 hours postoperatively | 
| Incidence of wound infection | Number of patients | Within the first week postoperatively | 
| Incidence of delayed wound healing | Number of patients | Within the first week postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vomiting, Dexamethasone, Super-hydration, Laparoscopic Cholecystectomy, Nausea, Postoperative