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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02726308

Enrollment

100

Registered

2016-04-01

Start date

2015-05-31

Completion date

2016-03-31

Last updated

2016-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting, Postoperative

Keywords

Dexamethasone, Super-hydration, Laparoscopic Cholecystectomy, Nausea, Vomiting, Postoperative

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.

Interventions

DRUGDexamethasone

5 mg I.V. Dexamethasone just before induction

DRUG10 ml/kg Ringer's lactate

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

DRUG30 ml/kg Ringer's lactate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026