Nausea and Vomiting, PostoperativePhase 2NCT02726308
Dexamethasone With Super-hydration for Prevention of Postoperative Nausea and Vomiting
A Phase 2 study testing Dexamethasone, 10 ml/kg Ringer's lactate and 30 ml/kg Ringer's lactate in people with Nausea and Vomiting, Postoperative, run by Assiut University at 1 site in Egypt.
Trial summary
Postoperative nausea and vomiting (PONV) are the most common and distressing side effects following Laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Nausea and Vomiting, Postoperative
- What is being tested?
- Dexamethasone, 10 ml/kg Ringer's lactate and 30 ml/kg Ringer's lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- May 2015to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II aged Elective laparoscopic cholecystectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Postoperative nausea and vomiting (PONV) are the most common and distressing side effects following Laparoscopic cholecystectomy
Read the 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.
- Conditions
- Nausea and Vomiting, Postoperative
- Being tested
- Dexamethasone, 10 ml/kg Ringer's lactate, 30 ml/kg Ringer's lactate
- Keywords
- Dexamethasone, Super-hydration, Laparoscopic Cholecystectomy, Nausea, Vomiting, Postoperative
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Decadron
5 mg I.V. Dexamethasone just before induction
10 ml/kg Ringer's lactateDrug
Also called Normal hydration
Intra-operative 10 ml/kg Ringer's lactate solution .
30 ml/kg Ringer's lactateDrug
Also called super-hydration
Intra-operative 30 ml/kg Ringer's lactate solution .
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Group | Active comparator | I.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution. Receives: Drug: Dexamethasone; Drug: 10 ml/kg Ringer's lactate |
| Dexamethasone and super-hydration Group | Active comparator | I.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution Receives: Drug: Dexamethasone; Drug: 30 ml/kg Ringer's lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within the first 24 hours postoperatively
Secondary outcomes (6)
Total number of patients who had nausea, vomiting or retching
Total number of patients who had nausea, vomiting or retching (number)
Measured: Within the first 24 hours postoperatively
Antiemetic usage
Total amount of ondansetron consumption (mg)
Measured: Within the first 24 hours postoperatively
Pain Score
A visual analogue scale (appropriate score)
Measured: Within the first 24 hours postoperatively
Total analgesic consumption
I.V Pethidine (mg)
Measured: Within the first 24 hours postoperatively
Incidence of wound infection
Number of patients
Measured: Within the first week postoperatively
Incidence of delayed wound healing
Number of patients
Measured: Within the first week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- sayed abd elshafy, MD, Principal investigator, associate professor of anesthesia and critical care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726308
- Sponsor's protocol ID
- IRB0000871550
- Status last verified
- Mar 2016
- First submitted
- 29 Mar 2016
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02726308
- Acronym / sponsor ID
- IRB0000871550
- Conditions
- Nausea and Vomiting, Postoperative
- Keywords
- Dexamethasone, Super-hydration, Laparoscopic Cholecystectomy, Nausea, Vomiting, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Group | Active comparator | Drug: Dexamethasone, Drug: 10 ml/kg Ringer's lactateI.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution. |
| Dexamethasone and super-hydration Group | Active comparator | Drug: Dexamethasone, Drug: 30 ml/kg Ringer's lactateI.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I or II aged Elective laparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Decadron5 mg I.V. Dexamethasone just before induction | Drug | Dexamethasone Group, Dexamethasone and super-hydration Group |
| 10 ml/kg Ringer's lactateAlso: Normal hydrationIntra-operative 10 ml/kg Ringer's lactate solution . | Drug | Dexamethasone Group |
| 30 ml/kg Ringer's lactateAlso: super-hydrationIntra-operative 30 ml/kg Ringer's lactate solution . | Drug | Dexamethasone and super-hydration Group |
Primary outcome
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)
6 secondary outcomes
Total number of patients who had nausea, vomiting or retching
Time frame: Within the first 24 hours postoperatively
Antiemetic usage
Time frame: Within the first 24 hours postoperatively
Pain Score
Time frame: Within the first 24 hours postoperatively
Total analgesic consumption
Time frame: Within the first 24 hours postoperatively
Incidence of wound infection
Time frame: Within the first week postoperatively
Incidence of delayed wound healing
Time frame: Within the first week postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Nausea and Vomiting, Postoperative
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sayed abd elshafy, MD principal investigator
associate professor of anesthesia and critical care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone, 10 ml/kg Ringer's lactate and 30 ml/kg Ringer's lactate in people with Nausea and Vomiting, Postoperative, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Nausea and Vomiting (PONV) (time frame: Within the first 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2016.