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

Assiut University

Status and phase: Completed; Phase 2

Conditions: Nausea and Vomiting, Postoperative

Treatments: Drug: 30 ml/kg Ringer's lactate; Drug: 10 ml/kg Ringer's lactate; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02726308

IRB0000871550

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Dexamethasone Group

Active Comparator group

Description:

I.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution.

Treatment:

Drug: Dexamethasone

Drug: 10 ml/kg Ringer's lactate

Dexamethasone and super-hydration Group

Active Comparator group

Description:

I.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution

Treatment:

Drug: Dexamethasone

Drug: 30 ml/kg Ringer's lactate