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Completed

NCT Number: NCT02726308

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

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

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Key information

Conditions

Nausea and Vomiting, Postoperative Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

5 mg I.V. Dexamethasone just before induction

Other names: Decadron

10 ml/kg Ringer's lactate

Drug

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

Other names: Normal hydration

30 ml/kg Ringer's lactate

Drug

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

Other names: super-hydration

Primary outcomes

  1. Postoperative Nausea and Vomiting (PONV)

    Time frame: 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 outcomes

  1. Total number of patients who had nausea, vomiting or retching

    Time frame: Within the first 24 hours postoperatively

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

  2. Antiemetic usage

    Time frame: Within the first 24 hours postoperatively

    Total amount of ondansetron consumption (mg)

  3. Pain Score

    Time frame: Within the first 24 hours postoperatively

    A visual analogue scale (appropriate score)

  4. Total analgesic consumption

    Time frame: Within the first 24 hours postoperatively

    I.V Pethidine (mg)

  5. Incidence of wound infection

    Time frame: Within the first week postoperatively

    Number of patients

  6. Incidence of delayed wound healing

    Time frame: Within the first week postoperatively

    Number of patients

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 1, 2016
Registry last updated
Apr 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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