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

Phase 2
Completed
Conditions
Nausea and Vomiting, Postoperative
Interventions
Drug: 10 ml/kg Ringer's lactate
Drug: 30 ml/kg Ringer's lactate
Registration Number
NCT02726308
Lead Sponsor
Assiut University
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Dexamethasone Group10 ml/kg Ringer's lactateI.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution.
Dexamethasone and super-hydration Group30 ml/kg Ringer's lactateI.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution
Dexamethasone GroupDexamethasoneI.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution.
Dexamethasone and super-hydration GroupDexamethasoneI.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution
Primary Outcome Measures
NameTimeMethod
Postoperative Nausea and Vomiting (PONV)Within the first 24 hours postoperatively

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)

Secondary Outcome Measures
NameTimeMethod
Antiemetic usageWithin the first 24 hours postoperatively

Total amount of ondansetron consumption (mg)

Total analgesic consumptionWithin the first 24 hours postoperatively

I.V Pethidine (mg)

Pain ScoreWithin the first 24 hours postoperatively

A visual analogue scale (appropriate score)

Incidence of delayed wound healingWithin the first week postoperatively

Number of patients

Total number of patients who had nausea, vomiting or retchingWithin the first 24 hours postoperatively

Total number of patients who had nausea, vomiting or retching (number)

Incidence of wound infectionWithin the first week postoperatively

Number of patients

Trial Locations

Locations (1)

Faculty of Medicine

🇪🇬

Assiut, Egypt

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