Postoperative Nausea and Vomiting (PONV)Phase 3NCT06847594
An Evaluation the Effect of Superhydration Versus Dextrose 10% for Prevention of Post Operative Nausea and Vomiting After Laparoscopic Cholecystectomy (Prospective Randomised Controlled Study)
A Phase 3 study testing ringer lactate (20ml/kg) and Dextrose 10% in people with Postoperative Nausea and Vomiting (PONV), run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if Dextrose 10% or superhydration works to prevent postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy. . Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting (PONV)
- What is being tested?
- ringer lactate (20ml/kg) and Dextrose 10%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Feb 2024to 10 Oct 2024
- Phase
- Phase 3
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 21- 60 years
- Patients with ASA classification I and II
Who cannot join
- Declining to give written informed consent.
- Patients with morbid obesity (BMI > 40).
- ASA classification III-V.
- Sever hypertension and heart failure.
- Significant hepatic or renal disorder.
- Patients with diagnosed diabetes mellitus type 1 or type 2.
- Patients with history of PONV currently receiving steroids or antiemetics.
- Pregnant or menstruating patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Superhydration Versus Dextrose 10% for Prevention of Post Operative Nausea and Vomiting After Laparoscopic Cholecystectomy (Prospective Randomised Controlled Study)
The goal of this clinical trial is to learn if Dextrose 10% or superhydration works to prevent postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
. The main questions it aims to answer are:
Read more
Does Dextrose 10% or superhydration lower the number of times participants gets an episode of nausea and vomititng after laparoscopic cholecystectomy surgery? Researchers will compare Dextrose 10% versus superhydration to a placebo (a look-alike substance that contains no drug) to see if glucose 10% or superhydation can work to prevent postoperative nausea and vomiting.
Participants will:
Take Dextrose 10% or superhydration or a placebo in the operation monitored for 4 hours after surgery to check on their nausea and vomiting state
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Being tested
- ringer lactate (20ml/kg), Dextrose 10%
- Keywords
- postoperative nausea and vomiting, nausea, vomiting, laparoscopic cholecystectomy, superhydration, glucose 10%, dextrose 10%
- 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.
ringer lactate (20ml/kg)Drug
Also called Superhydration
ringer lactate 20 ml/kg over the first 90 to 120 minutes after induction intraoperatively
Dextrose 10%Drug
Dextrose 10% 250 ml over 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Superhydration group receiving 20 ml/kg | Active comparator | Group Ringer Lactate planned to receive ringer lactate 20 ml/kg over the first 90 to 120 minutes Receives: Drug: ringer lactate (20ml/kg) |
| Dextrose group receiving Dextrose 10% | Experimental | Group Dextrose planned to receive Dextrose 10% 250 ml over 60 minutes added to 3 ml/kg/Hr ringer lactate as intraoperative fluid maintenance Receives: Drug: Dextrose 10% |
| control group receiving 3ml/kg/hr | No intervention | Group control planned to receive ringer lactate with rate 3ml /kg /Hr as intraoperative fluid maintenance added to the loading dose according to Ain Shams Anesthesia and Critical care department protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of Post operative nausea and vomiting in the study treatment groups
Measured: Postoperative 4 hours stay in PACU
Secondary outcomes (4)
Frequency of vomiting episodes
Measured: Postoperative 4 hours stay in PACU
Measurement of PONV severity scores
Severity of PONV was assessed using a 4-point Verbal Descriptive Scale (VDS) which consists of:
Score 0= no PONV: no complaint of nausea or vomiting; Score 1= mild PONV: patient complains from nausea but doesn't need antiemetic treatment.
Score 2= moderate PONV: patient complains from nausea and need antiemetic treatment; Score 3= severe PONV: patient complains from nausea with episode of vomiting requiring antiemetic treatment.
PONV scores were obtained every half hour
Measured: Postoperative 4 hours stay in PACU
Time from extubation till discharge from PACU
Measured: From the moment of extubation till the moment of discharge from PACU with patient being completely vitally stable and nausea and vomiting free , assessed to be from 4 to 8 hours
total antiemetic medication consumption
Severity of PONV was assessed using a 4-point Verbal Descriptive Scale (VDS) which consists of:
Score 0= no PONV: no complaint of nausea or vomiting; Score 1= mild PONV: patient complains from nausea but doesn't need antiemetic treatment.
Score 2= moderate PONV: patient complains from nausea and need antiemetic treatment; Score 3= severe PONV: patient complains from nausea with episode of vomiting requiring antiemetic treatment.
PONV scores were obtained every half hour, Rescue antiemetic granisetron 1 mg IV was given when VDS scores were 2 or more. Medications were given only after excluding other causes of PONV such as hypovolemia, hypotension, hypoxia. The total number of doses of antiemetics used were obtained every half hour from the time of entry to the PACU for 4 hours
Measured: Postoperative period 4 hours stay in PACU. ( if the patient needed to stay for longer duration in the PACU for any medical reason then any antiemetic used in this period will be recorded as well )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start25 Feb 2024
- Primary completion25 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and Vomiting (PONV)Studies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aya H. M. Ahmad, Assistant professor, MD, Principal investigator, Ain Shams University Faculty of MedicineWael A. M. Abdelwahab, Assistant professor, MD, Principal investigator, Ain Shams University Faculty of MedicineMohamed A. Elgendy, Assistant professor, MD, Study director, Ain Shams University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847594
- Sponsor's protocol ID
- FMASU MS129/2024
- Status last verified
- Dec 2024
- First submitted
- 15 Jan 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD that will be shared will be Age, Sex, BMI, ASA score , operation duration and anesthesia duration , PONV severity score, nausea and vomiting frequency , total antiemetic usage intra and postoperative in the PACU and time needed to discharge from the PACU
Publications
Stephenson SJ, Jiwanmall M, Cherian NE, Kamakshi S, Williams A. Reduction in post-operative nausea and vomiting (PONV) by preoperative risk stratification and adherence to a standardized anti emetic prophylaxis protocol in the day-care surgical population. J Family Med Prim Care. 2021 Feb;10(2):865-870. doi: 10.4103/jfmpc.jfmpc_1692_20. Epub 2021 Feb 27.
PubMed 34041090
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superhydration Versus Dextrose 10% for Prevention of Post Operative Nausea and Vomiting After Laparoscopic Cholecystectomy (Prospective Randomised Controlled Study)
- ClinicalTrials.gov ID
- NCT06847594
- Acronym / sponsor ID
- FMASU MS129/2024
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Keywords
- postoperative nausea and vomiting, nausea, vomiting, laparoscopic cholecystectomy, superhydration, glucose 10%, dextrose 10%
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 26 Feb 2025 (actual)
- 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.
The goal of this clinical trial is to learn if Dextrose 10% or superhydration works to prevent postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
. The main questions it aims to answer are:
Does Dextrose 10% or superhydration lower the number of times participants gets an episode of nausea and vomititng after laparoscopic cholecystectomy surgery? Researchers will compare Dextrose 10% versus superhydration to a placebo (a look-alike substance that contains no drug) to see if glucose 10% or superhydation can work to prevent postoperative nausea and vomiting.
Participants will:
Take Dextrose 10% or superhydration or a placebo in the operation monitored for 4 hours after surgery to check on their nausea and vomiting state
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Superhydration group receiving 20 ml/kg | Active comparator | Drug: ringer lactate (20ml/kg)Group Ringer Lactate planned to receive ringer lactate 20 ml/kg over the first 90 to 120 minutes |
| Dextrose group receiving Dextrose 10% | Experimental | Drug: Dextrose 10%Group Dextrose planned to receive Dextrose 10% 250 ml over 60 minutes added to 3 ml/kg/Hr ringer lactate as intraoperative fluid maintenance |
| control group receiving 3ml/kg/hr | No intervention | –Group control planned to receive ringer lactate with rate 3ml /kg /Hr as intraoperative fluid maintenance added to the loading dose according to Ain Shams Anesthesia and Critical care department protocol |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age: 21- 60 years
- Patients with ASA classification I and II
Key exclusion criteria (8 listed)
- Declining to give written informed consent.
- Patients with morbid obesity (BMI > 40).
- ASA classification III-V.
- Sever hypertension and heart failure.
- Significant hepatic or renal disorder.
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 |
|---|---|---|
| ringer lactate (20ml/kg)Also: Superhydrationringer lactate 20 ml/kg over the first 90 to 120 minutes after induction intraoperatively | Drug | Superhydration group receiving 20 ml/kg |
| Dextrose 10%Dextrose 10% 250 ml over 60 minutes | Drug | Dextrose group receiving Dextrose 10% |
Primary outcome
To compare the incidence of Post operative nausea and vomiting in the study treatment groups
Time frame: Postoperative 4 hours stay in PACU
4 secondary outcomes
Frequency of vomiting episodes
Time frame: Postoperative 4 hours stay in PACU
Measurement of PONV severity scores
Time frame: Postoperative 4 hours stay in PACU
Time from extubation till discharge from PACU
Time frame: From the moment of extubation till the moment of discharge from PACU with patient being completely vitally stable and nausea and vomiting free , assessed to be from 4 to 8 hours
total antiemetic medication consumption
Time frame: Postoperative period 4 hours stay in PACU. ( if the patient needed to stay for longer duration in the PACU for any medical reason then any antiemetic used in this period will be recorded as well )
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 26 Feb 2025.
- Results publication: PubMed 34041090Stephenson SJ, Jiwanmall M, Cherian NE, Kamakshi S, Williams A. Reduction in post-operative nausea and vomiting (PONV) by preoperative risk stratification and adherence to a standardized anti emetic prophylaxis protocol in the day-care surgical population. J Family Med Prim Care. 2021 Feb;10(2):865-870. doi: 10.4103/jfmpc.jfmpc_1692_20. Epub 2021 Feb 27.
- Individual participant dataSharing planned: Yes. The IPD that will be shared will be Age, Sex, BMI, ASA score , operation duration and anesthesia duration , PONV severity score, nausea and vomiting frequency , total antiemetic usage intra and postoperative in the PACU and time needed to discharge from the PACU
Related trials for Postoperative Nausea and Vomiting (PONV)
Not yet recruitingObservational study
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
Aya H. M. Ahmad, Assistant professor, MD principal investigator
Ain Shams University Faculty of Medicine
Wael A. M. Abdelwahab, Assistant professor, MD principal investigator
Ain Shams University Faculty of Medicine
Mohamed A. Elgendy, Assistant professor, MD study director
Ain Shams University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ringer lactate (20ml/kg) and Dextrose 10% in people with Postoperative Nausea and Vomiting (PONV), run by Ain Shams 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 2 inclusion and 8 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 26 Feb 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To compare the incidence of Post operative nausea and vomiting in the study treatment groups (time frame: Postoperative 4 hours stay in PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06847594, which also lists 1 linked publication.
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 26 Feb 2025.