Postoperative Nausea and VomitingNCT05932160
Effect of Intravenous Dextrose on PONV in Patients Undergoing Gynecological Laparoscopy
A study testing 5% glucose and lactated ringers in people with Postoperative Nausea and Vomiting, run by Weifang Medical University at 1 site in China.
Trial summary
This study is to explore the relationship between intravenous infusion of dextrose during emergence from anesthesia and the incidence of PONV in patients undergoing gynecology laparoscopy (GL). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- 5% glucose and lactated ringers
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Dec 2023
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II;
- Performing gynecologic laparoscopic procedures under general anesthesia;
Who cannot join
- age <18 or >75
- severe hypertension,diabetes mellitus, significant hepatic or renal disease
- inability to follow protocol
- refusal to participant
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiang Liu
Weifang, Shandong, 265100
Jiang Liu, B.S, 17667192336, Time1987fx@163.com
About this study
Official title: Research Investigator
This study is to explore the relationship between intravenous infusion of dextrose during emergence from anesthesia and the incidence of PONV in patients undergoing gynecology laparoscopy (GL).
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- 5% glucose, lactated ringers
- Keywords
- PONV
- 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.
5% glucoseOther
Also called 5% dextrose
Patients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU.
lactated ringersOther
Patients in the control group were infused intravenously with lactated ringers (500 ml/h) in the PACU.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | Patients in the experimental group were infused intravenously with 5% dextrose (400 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator. Receives: Other: 5% glucose |
| Control group | Active comparator | Patients in the control group were infused intravenously with ringer lactate solution (400 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator. Receives: Other: lactated ringers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting
The severity and incidence of PONV at 0.5 hours postoperatively.
Measured: Measured at 0.5 hours postoperatively.
Postoperative nausea and vomiting
The severity and incidence of PONV at 2 hours postoperatively.
Measured: Measured at 2 hours postoperatively.
Postoperative nausea and vomiting
The severity and incidence of PONV at 24 hours postoperatively.
Measured: Measured at 24 hours postoperatively.
Secondary outcomes (6)
Consumption of postoperative analgesic
Record the type and dosage of postoperative analgesic within 24 hours after surgery.
Measured: Approximately 24 hours after surgery.
Postoperative pain response
The Visual Analog Score was used to assess pain response at 0.5 hours postoperatively.
The score ranges from 0 (pain free or no pain) to 10 (worst pain).
Measured: Measured at 0.5 hours postoperatively.
Postoperative pain response
The Visual Analog Score was used to assess pain response at 2 hours postoperatively.
The score ranges from 0 (pain free or no pain) to 10 (worst pain).
Measured: Measured at 2 hours postoperatively.
Postoperative pain response
The Visual Analog Score was used to assess pain response at 24 hours postoperatively.
The score ranges from 0 (pain free or no pain) to 10 (worst pain).
Measured: Measured at 24 hours postoperatively.
Recovery time of PACU
Record PACU recovery time in hours. The criteria for discharge from PACU was the achievement of a modified Aldrete score ≥ 9.
Measured: Approximately 24 hours after surgery.
Consumption of postoperative rescue antiemetic
Record the type and dosage of postoperative rescue antiemetic within 24 hours after surgery.
Measured: Approximately 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Jun 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weifang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Liu, Weifang Medical University
- Investigators
- Jiang Liu, B.S, Principal investigator, Weifang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932160
- Sponsor's protocol ID
- 2023YX104
- Status last verified
- Nov 2023
- First submitted
- 6 Jun 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu J, Zhang F, Cheng L, Zheng H, Ma R, Wang X, Fang S, Liu Y. Is Intravenous Dextrose Infusion During Emergence From Anesthesia Effective in Improving the PONV in Gynecologic Laparoscopy? A Randomized Controlled Trial. J Minim Invasive Gynecol. 2024 Apr;31(4):285-294. doi: 10.1016/j.jmig.2024.01.006. Epub 2024 Jan 17.
PubMed 38237658
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Investigator
- ClinicalTrials.gov ID
- NCT05932160
- Acronym / sponsor ID
- 2023YX104
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- PONV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Weifang Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 6 Jul 2023 (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.
This study is to explore the relationship between intravenous infusion of dextrose during emergence from anesthesia and the incidence of PONV in patients undergoing gynecology laparoscopy (GL).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Other: 5% glucosePatients in the experimental group were infused intravenously with 5% dextrose (400 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator. |
| Control group | Active comparator | Other: lactated ringersPatients in the control group were infused intravenously with ringer lactate solution (400 ml/h) in the PACU. The study outcomes were collected at three assessment periods, 0-0.5 h, 0.5-6 h, 6-24 h, after anesthesia by an independent investigator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I or II;
- Performing gynecologic laparoscopic procedures under general anesthesia;
Key exclusion criteria (4 listed)
- age <18 or >75
- severe hypertension,diabetes mellitus, significant hepatic or renal disease
- inability to follow protocol
- refusal to participant
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 |
|---|---|---|
| 5% glucoseAlso: 5% dextrosePatients in the experimental group were infused intravenously with 5% dextrose (500 ml/h) in the PACU. | Other | Experimental group |
| lactated ringersPatients in the control group were infused intravenously with lactated ringers (500 ml/h) in the PACU. | Other | Control group |
Primary outcome
Postoperative nausea and vomiting
Time frame: Measured at 0.5 hours postoperatively.
The severity and incidence of PONV at 0.5 hours postoperatively.
Postoperative nausea and vomiting
Time frame: Measured at 2 hours postoperatively.
The severity and incidence of PONV at 2 hours postoperatively.
Postoperative nausea and vomiting
Time frame: Measured at 24 hours postoperatively.
The severity and incidence of PONV at 24 hours postoperatively.
6 secondary outcomes
Consumption of postoperative analgesic
Time frame: Approximately 24 hours after surgery.
Postoperative pain response
Time frame: Measured at 0.5 hours postoperatively.
Postoperative pain response
Time frame: Measured at 2 hours postoperatively.
Postoperative pain response
Time frame: Measured at 24 hours postoperatively.
Recovery time of PACU
Time frame: Approximately 24 hours after surgery.
Consumption of postoperative rescue antiemetic
Time frame: Approximately 24 hours after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 38237658Liu J, Zhang F, Cheng L, Zheng H, Ma R, Wang X, Fang S, Liu Y. Is Intravenous Dextrose Infusion During Emergence From Anesthesia Effective in Improving the PONV in Gynecologic Laparoscopy? A Randomized Controlled Trial. J Minim Invasive Gynecol. 2024 Apr;31(4):285-294. doi: 10.1016/j.jmig.2024.01.006. Epub 2024 Jan 17.
- Individual participant dataSharing planned: No
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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.
Jiang Liu, B.S principal investigator
Weifang Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5% glucose and lactated ringers in people with Postoperative Nausea and Vomiting, run by Weifang Medical University at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Liu, B.S (17667192336, Time1987fx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomiting (time frame: Measured at 0.5 hours postoperatively.). The study lists 3 primary outcomes in all. 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 NCT05932160, 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 7 Nov 2023.