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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-03-31

Brief Summary

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

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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.

Conditions

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Nausea and Vomiting, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Dexamethasone Group

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

5 mg I.V. Dexamethasone just before induction

10 ml/kg Ringer's lactate

Intervention Type DRUG

Intra-operative 10 ml/kg Ringer's lactate solution .

Dexamethasone and super-hydration Group

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

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

5 mg I.V. Dexamethasone just before induction

30 ml/kg Ringer's lactate

Intervention Type DRUG

Intra-operative 30 ml/kg Ringer's lactate solution .

Interventions

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Dexamethasone

5 mg I.V. Dexamethasone just before induction

Intervention Type DRUG

10 ml/kg Ringer's lactate

Intra-operative 10 ml/kg Ringer's lactate solution .

Intervention Type DRUG

30 ml/kg Ringer's lactate

Intra-operative 30 ml/kg Ringer's lactate solution .

Intervention Type DRUG

Other Intervention Names

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Decadron Normal hydration super-hydration

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No