Postoperative Nausea and VomitingNCT04726436
Dextrose Effect on Postoperative Nausea and Vomiting (PONV)
A study testing Dextrose 5% in water and Dextrose 10% in people with Postoperative Nausea and Vomiting, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study to assess which time and dose of dextrose solution more effective in decreasing postoperative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Dextrose 5% in water and Dextrose 10%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2021to 1 May 2021
- Phase
- Interventional
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female non-smokers adults (age 18-65 years)
- ASA I-II who were listed for elective surgery under general anesthesia (surgery which is risk for PONV).
Who cannot join
- Severe hypertension
- Coagulopathy
- Significant hepatic or renal disease
- Diabetes mellitus or abnormal blood glucose on the morning of surgery
- Withdrawal of consent
- Severe intraoperative hypotension requiring large volume intravascular fluid treatment
- Protocol violations including nitrous oxide administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Timing and Dosing of Dextrose Solution on Postoperative Nausea and Vomiting.
The aim of this study to assess which time and dose of dextrose solution more effective in decreasing postoperative nausea and vomiting.
Read the detailed description
All patients signed informed consent after excluding patients not candidate for the study.patients were divided to three groups, taking either 0.9% saline as control group(group C), dextrose 5%(group D5) or dextrose 10%(group D10).
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Dextrose 5% in water, Dextrose 10%, Saline placebo
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose 5% in waterOther
One hour before operation, patients were given dexrose 5%100/hour only for 2 hours to end at about middle of surgery
Dextrose 10%Other
One hour before operation, patients were given dexrose 10 %100/hour only for 2 hours to end at about middle of surgery
Saline placeboOther
Also called Normal saline
One hour before operation, patients were given normal saline100/hour only for 2 hours to end at about middle of surgery
| Study group | Role | What they receive |
|---|---|---|
| Dextrose 5% | Experimental | 100 mL/ hour of dextrose 5% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon to assess the timing and dosing of dextrose solution effect on PONV. Receives: Other: Dextrose 5% in water |
| Dextrose 10% | Experimental | 100 mL/ hour of dextrose 10% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon Receives: Other: Dextrose 10% |
| Saline placebo | Placebo comparator | 100 mL/ hour of normal saline were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon Receives: Other: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting within 24 hour
Number of participants who experienced PONV grade ≥2 as assessed by PONV score . The PACU nurses assessed and documented PONV using a Verbal Descriptive Scale, which correlates to visual analog nausea scores, with an objective measure of severity: 0 = no PONV: patient reports no nausea and has had no emesis episodes; 1 = mild PONV: patient reports nausea but declines antiemetic treatment; 2 = moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3 = severe PONV: nausea with any emesis episode (retching or vomiting). The score was obtained at 0, 30, 60, 90, and 120 minutes after PACU arrival; thus 5 scores were recorded during PACU stay. A 24-hour PONV assessment that elicited any nausea and emesis episode since PACU discharge was obtained by a blinded investigator by telephone or in person at the patient's bedside (delayed PONV).
Measured: 24hour after surgery
Secondary outcomes (2)
Number of doses of antiemetics required to control PONV.
Frequency of doses of antiemetics required to control postoperative nausea and vomiting, initial antiemetic treatment was 10 mg slow IV metoclopramide for occurred nausea or 4 mg IV ondansetron for occurred nausea \& vomiting or if the previous treatment failed for nausea
Measured: 24hour postoperative
Number of classes of antiemetics
Frequency of classes of antiemetics required to control postoperative nausea and vomiting, Initial antiemetic treatment was 10 mg slow IV metoclopramide for occurred nausea or 4 mg IV ondansetron for occurred nausea \& vomiting or if the previous treatment failed for nausea
Measured: 24 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start25 Jan 2021
- Primary completion1 Apr 2021
- Study completion1 May 2021
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 VomitingStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726436
- Sponsor's protocol ID
- Dextrose PONV
- Status last verified
- Aug 2021
- First submitted
- 24 Jan 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zorrilla-Vaca A, Marmolejo-Posso D, Stone A, Li J, Grant MC. Perioperative Dextrose Infusion and Postoperative Nausea and Vomiting: A Meta-analysis of Randomized Trials. Anesth Analg. 2019 Oct;129(4):943-950. doi: 10.1213/ANE.0000000000004019.
PubMed 30649067
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Timing and Dosing of Dextrose Solution on Postoperative Nausea and Vomiting.
- ClinicalTrials.gov ID
- NCT04726436
- Acronym / sponsor ID
- Dextrose PONV
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 27 Jan 2021 (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 aim of this study to assess which time and dose of dextrose solution more effective in decreasing postoperative nausea and vomiting.
Detailed description
All patients signed informed consent after excluding patients not candidate for the study.patients were divided to three groups, taking either 0.9% saline as control group(group C), dextrose 5%(group D5) or dextrose 10%(group D10).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dextrose 5% | Experimental | Other: Dextrose 5% in water100 mL/ hour of dextrose 5% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon to assess the timing and dosing of dextrose solution effect on PONV. |
| Dextrose 10% | Experimental | Other: Dextrose 10%100 mL/ hour of dextrose 10% were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon |
| Saline placebo | Placebo comparator | Other: Saline placebo100 mL/ hour of normal saline were given starting 1 hour before operation and continue till approximately middle of surgery by communicating with surgeon |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female non-smokers adults (age 18-65 years)
- ASA I-II who were listed for elective surgery under general anesthesia (surgery which is risk for PONV).
Key exclusion criteria (7 listed)
- Severe hypertension
- Coagulopathy
- Significant hepatic or renal disease
- Diabetes mellitus or abnormal blood glucose on the morning of surgery
- Withdrawal of consent
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 |
|---|---|---|
| Dextrose 5% in waterOne hour before operation, patients were given dexrose 5%100/hour only for 2 hours to end at about middle of surgery | Other | Dextrose 5% |
| Dextrose 10%One hour before operation, patients were given dexrose 10 %100/hour only for 2 hours to end at about middle of surgery | Other | Dextrose 10% |
| Saline placeboAlso: Normal salineOne hour before operation, patients were given normal saline100/hour only for 2 hours to end at about middle of surgery | Other | Saline placebo |
Primary outcome
Postoperative nausea and vomiting within 24 hour
Time frame: 24hour after surgery
Number of participants who experienced PONV grade ≥2 as assessed by PONV score . The PACU nurses assessed and documented PONV using a Verbal Descriptive Scale, which correlates to visual analog nausea scores, with an objective measure of severity: 0 = no PONV: patient reports no nausea and has had no emesis episodes; 1 = mild PONV: patient reports nausea but declines antiemetic treatment; 2 = moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3 = severe PONV: nausea with any emesis episode (retching or vomiting). The score was obtained at 0, 30, 60, 90, and 120 minutes after PACU arrival; thus 5 scores were recorded during PACU stay. A 24-hour PONV assessment that elicited any nausea and emesis episode since PACU discharge was obtained by a blinded investigator by telephone or in person at the patient's bedside (delayed PONV).
2 secondary outcomes
Number of doses of antiemetics required to control PONV.
Time frame: 24hour postoperative
Number of classes of antiemetics
Time frame: 24 hour postoperative
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 30 Aug 2021.
- Background: PubMed 30649067Zorrilla-Vaca A, Marmolejo-Posso D, Stone A, Li J, Grant MC. Perioperative Dextrose Infusion and Postoperative Nausea and Vomiting: A Meta-analysis of Randomized Trials. Anesth Analg. 2019 Oct;129(4):943-950. doi: 10.1213/ANE.0000000000004019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose 5% in water and Dextrose 10% in people with Postoperative Nausea and Vomiting, 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 2 inclusion and 7 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 30 Aug 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 within 24 hour (time frame: 24hour after surgery). 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 NCT04726436, 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 30 Aug 2021.