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

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

Study Overview

• Status: Completed
• Conditions: Nausea and Vomiting, Postoperative
• Intervention / Treatment: Drug: Dexamethasone; Drug: 10 ml/kg Ringer's lactate; Drug: 30 ml/kg Ringer's lactate

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexamethasone Group; I.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution.	Drug: Dexamethasone; 5 mg I.V. Dexamethasone just before induction; Other Names: Decadron; Drug: 10 ml/kg Ringer's lactate; Intra-operative 10 ml/kg Ringer's lactate solution .; Other Names: Normal hydration
Active Comparator: Dexamethasone and super-hydration Group; I.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution	Drug: Dexamethasone; 5 mg I.V. Dexamethasone just before induction; Other Names: Decadron; Drug: 30 ml/kg Ringer's lactate; Intra-operative 30 ml/kg Ringer's lactate solution .; Other Names: super-hydration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Nausea and Vomiting (PONV)	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)	Within the first 24 hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: sayed abd elshafy, MD, associate professor of anesthesia and critical care

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Estimate): April 1, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Dexamethasone; Postoperative; Laparoscopic Cholecystectomy; Super-hydration
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: IRB0000871550

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided