CholelithiasisPhase 4NCT00674713
Effect of Acupuncture on Postoperative Nausea and Vomiting
A Phase 4 study testing Acupuncture, Ondansetron and Physiological saline solution in people with Cholelithiasis, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
The aim of the study is to investigate if P6 acupuncture made after induction of general anaesthesia might be effective for the prevention of PONV as ondansetron and if the acupuncture-ondansetron combination could enhance single therapy efficacy in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Acupuncture, Ondansetron and Physiological saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2006to Sep 2007
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ASA I-II scheduled for elective laparoscopic cholecystectomy.
Who cannot join
- Patient's refusal
- Patients with history of carpal tunnel syndrome or eczema at P6 point
- Pregnant patients
- Female patients in a phase of the menstrual cycle other than premenstrual, nausea and vomiting within 24 hours before anaesthesia
- Known allergy to anti-inflammatory drugs, opioids and ondansetron.
- Patients with a pre-existing chronic pain disorder or with a gastrointestinal disease.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate if P6 acupuncture made after induction of general anaesthesia might be effective for the prevention of PONV as ondansetron and if the acupuncture-ondansetron combination could enhance single therapy efficacy in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Cholelithiasis
- Being tested
- Acupuncture, Ondansetron, Physiological saline solution, Sham acupuncture, Acupuncture at P6 point
- Keywords
- Patients undergoing laparoscopic cholecystectomy for cholelithiasis
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
OndansetronDrug
Physiological saline solutionDrug
Sham acupunctureOther
OndansetronDrug
Acupuncture at P6 pointOther
Physiological saline solutionDrug
Sham acupunctureOther
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients receiving acupuncture at P6 point plus physiological saline solution Receives: Other: Acupuncture; Drug: Physiological saline solution |
| B | Active comparator | Patients receiving ondansetron plus sham acupuncture Receives: Drug: Ondansetron; Other: Sham acupuncture |
| C | Other | Patients receiving ondansetron plus acupuncture at P6 point Receives: Drug: Ondansetron; Other: Acupuncture at P6 point |
| D | Placebo comparator | Patients receiving physiological saline solution plus sham acupuncture Receives: Drug: Physiological saline solution; Other: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting
Measured: 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2008 (estimated)
- Study startJan 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Investigators
- Germano De Cosmo, MD, Principal investigator, Catholic University of Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00674713
- Sponsor's protocol ID
- 1014/05
- Status last verified
- May 2008
- First submitted
- 5 May 2008
- Last updated
- 8 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acupuncture on Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT00674713
- Acronym / sponsor ID
- 1014/05
- Conditions
- Cholelithiasis
- Keywords
- Patients undergoing laparoscopic cholecystectomy for cholelithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 8 May 2008 (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.
The aim of the study is to investigate if P6 acupuncture made after induction of general anaesthesia might be effective for the prevention of PONV as ondansetron and if the acupuncture-ondansetron combination could enhance single therapy efficacy in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Acupuncture, Drug: Physiological saline solutionPatients receiving acupuncture at P6 point plus physiological saline solution |
| B | Active comparator | Drug: Ondansetron, Other: Sham acupuncturePatients receiving ondansetron plus sham acupuncture |
| C | Other | Drug: Ondansetron, Other: Acupuncture at P6 pointPatients receiving ondansetron plus acupuncture at P6 point |
| D | Placebo comparator | Drug: Physiological saline solution, Other: Sham acupuncturePatients receiving physiological saline solution plus sham acupuncture |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ASA I-II scheduled for elective laparoscopic cholecystectomy.
Key exclusion criteria (6 listed)
- Patient's refusal
- Patients with history of carpal tunnel syndrome or eczema at P6 point
- Pregnant patients
- Female patients in a phase of the menstrual cycle other than premenstrual, nausea and vomiting within 24 hours before anaesthesia
- Known allergy to anti-inflammatory drugs, opioids and ondansetron.
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 |
|---|---|---|
| Acupuncture | Other | A |
| Ondansetron | Drug | B |
| Physiological saline solution | Drug | A |
| Sham acupuncture | Other | B |
| Ondansetron | Drug | C |
| Acupuncture at P6 point | Other | C |
| Physiological saline solution | Drug | D |
| Sham acupuncture | Other | D |
Primary outcome
postoperative nausea and vomiting
Time frame: 24 postoperative hours
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 8 May 2008.
Related trials for Cholelithiasis
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Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
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Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
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Electrosurgical Patterns and Learning Curve in Elective 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.
Germano De Cosmo, MD principal investigator
Catholic University of Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acupuncture, Ondansetron and Physiological saline solution in people with Cholelithiasis, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 6 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 8 May 2008. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (time frame: 24 postoperative hours). 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 8 May 2008.