Back to resultsDexamethasone With Super-hydration for Prevention of Postoperative Nausea and Vomiting
Primary Purpose
Nausea and Vomiting, Postoperative
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dexamethasone
10 ml/kg Ringer's lactate
30 ml/kg Ringer's lactate
Sponsored by
About this trial
This is an interventional prevention trial for Nausea and Vomiting, Postoperative focused on measuring Dexamethasone, Super-hydration, Laparoscopic Cholecystectomy, Nausea, Vomiting, Postoperative
Eligibility Criteria
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
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dexamethasone Group
Dexamethasone and super-hydration Group
Arm Description
I.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution.
I.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Total number of patients who had nausea, vomiting or retching
Total number of patients who had nausea, vomiting or retching (number)
Antiemetic usage
Total amount of ondansetron consumption (mg)
Pain Score
A visual analogue scale (appropriate score)
Total analgesic consumption
I.V Pethidine (mg)
Incidence of wound infection
Number of patients
Incidence of delayed wound healing
Number of patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02726308
Brief Title
Dexamethasone With Super-hydration for Prevention of Postoperative Nausea and Vomiting
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Postoperative
Keywords
Dexamethasone, Super-hydration, Laparoscopic Cholecystectomy, Nausea, Vomiting, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone Group
Arm Type
Active Comparator
Arm Description
I.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution.
Arm Title
Dexamethasone and super-hydration Group
Arm Type
Active Comparator
Arm Description
I.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
5 mg I.V. Dexamethasone just before induction
Intervention Type
Drug
Intervention Name(s)
10 ml/kg Ringer's lactate
Other Intervention Name(s)
Normal hydration
Intervention Description
Intra-operative 10 ml/kg Ringer's lactate solution .
Intervention Type
Drug
Intervention Name(s)
30 ml/kg Ringer's lactate
Other Intervention Name(s)
super-hydration
Intervention Description
Intra-operative 30 ml/kg Ringer's lactate solution .
Primary Outcome Measure Information:
Title
Postoperative Nausea and Vomiting (PONV)
Description
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)
Time Frame
Within the first 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Total number of patients who had nausea, vomiting or retching
Description
Total number of patients who had nausea, vomiting or retching (number)
Time Frame
Within the first 24 hours postoperatively
Title
Antiemetic usage
Description
Total amount of ondansetron consumption (mg)
Time Frame
Within the first 24 hours postoperatively
Title
Pain Score
Description
A visual analogue scale (appropriate score)
Time Frame
Within the first 24 hours postoperatively
Title
Total analgesic consumption
Description
I.V Pethidine (mg)
Time Frame
Within the first 24 hours postoperatively
Title
Incidence of wound infection
Description
Number of patients
Time Frame
Within the first week postoperatively
Title
Incidence of delayed wound healing
Description
Number of patients
Time Frame
Within the first week postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sayed abd elshafy, MD
Organizational Affiliation
associate professor of anesthesia and critical care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Dexamethasone With Super-hydration for Prevention of Postoperative Nausea and Vomiting
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