Postoperative Nausea and VomitingNCT02944942
Risk Factors for Postoperative Nausea/Vomiting
An observational study of Postoperative Nausea and Vomiting, run by Khon Kaen University at 1 site in Thailand.
Trial summary
General anesthetic technique plays a key role in most surgical procedures. This technique has some complications especially postoperative nausea/vomiting (PONV). This complication can lead to serious problems. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- General anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2016to Feb 2017
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients undergoing elective surgery under general anesthesia
Who may be able to join
- ASA classification I-III
Who cannot join
- Incomplete or illegible medical records
- Patients who underwent cardio-thoracic surgery
- Patient who had chronic treatment with antiemetic drugs
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Srinagarind Hospital, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
About this study
Official title: Risk Factors for Postoperative Nausea/Vomiting After Implementation of Prophylaxis Guideline for High Risk Patients
General anesthetic technique plays a key role in most surgical procedures. This technique has some complications especially postoperative nausea/vomiting (PONV). This complication can lead to serious problems. Department of Anesthesiology has developed and implemented a PONV prophylaxis guideline for high risk PONV patients but PONV still remains.
Read the detailed description
Objective: To identify risk factors for PONV after implementation of PONV prophylaxis guideline.
Methods: This will be a retrospective analytic study. Relevant clinical data from medical records of adult patients undergoing general anesthesia in Srinagarind Hospital from November 2014 to February 2015 will be used to identify relevant risk factors.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- General anesthesia
- 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.
General anesthesiaProcedure or surgery
Patients undergoing general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Postoperative nausea and vomiting | Group 1: Patients undergoing general anesthesia with postoperative nausea and vomiting Group 2: Patients undergoing general anesthesia without postoperative nausea and vomiting Receives: Procedure: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting
Measured: through study completion, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Sirirat Tribuddharat, MD, Principal investigator, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944942
- Sponsor's protocol ID
- HE571413
- Status last verified
- Feb 2017
- First submitted
- 25 Oct 2016
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
PubMed 10485781Blanc VF, Ruest P, Milot J, Jacob JL, Tang A. Antiemetic prophylaxis with promethazine or droperidol in paediatric outpatient strabismus surgery. Can J Anaesth. 1991 Jan;38(1):54-60. doi: 10.1007/BF03009164.
PubMed 1989740Chatterjee S, Rudra A, Sengupta S. Current concepts in the management of postoperative nausea and vomiting. Anesthesiol Res Pract. 2011;2011:748031. doi: 10.1155/2011/748031. Epub 2011 Nov 3.
PubMed 22110499Doubravska L, Dostalova K, Fritscherova S, Zapletalova J, Adamus M. Incidence of postoperative nausea and vomiting in patients at a university hospital. Where are we today? Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2010 Mar;154(1):69-76. doi: 10.5507/bp.2010.012.
PubMed 20445713Jokinen J, Smith AF, Roewer N, Eberhart LH, Kranke P. Management of postoperative nausea and vomiting: how to deal with refractory PONV. Anesthesiol Clin. 2012 Sep;30(3):481-93. doi: 10.1016/j.anclin.2012.07.003. Epub 2012 Aug 14.
PubMed 22989590
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postoperative Nausea/Vomiting After Implementation of Prophylaxis Guideline for High Risk Patients
- ClinicalTrials.gov ID
- NCT02944942
- Acronym / sponsor ID
- HE571413
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 26 Oct 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.
General anesthetic technique plays a key role in most surgical procedures. This technique has some complications especially postoperative nausea/vomiting (PONV). This complication can lead to serious problems. Department of Anesthesiology has developed and implemented a PONV prophylaxis guideline for high risk PONV patients but PONV still remains.
Detailed description
Objective: To identify risk factors for PONV after implementation of PONV prophylaxis guideline.
Methods: This will be a retrospective analytic study. Relevant clinical data from medical records of adult patients undergoing general anesthesia in Srinagarind Hospital from November 2014 to February 2015 will be used to identify relevant risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative nausea and vomiting | – | Procedure: General anesthesiaGroup 1: Patients undergoing general anesthesia with postoperative nausea and vomiting Group 2: Patients undergoing general anesthesia without postoperative nausea and vomiting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective surgery under general anesthesia
Key inclusion criteria (1 listed)
- ASA classification I-III
Key exclusion criteria (3 listed)
- Incomplete or illegible medical records
- Patients who underwent cardio-thoracic surgery
- Patient who had chronic treatment with antiemetic drugs
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 |
|---|---|---|
| General anesthesiaPatients undergoing general anesthesia | Procedure or surgery | Postoperative nausea and vomiting |
Primary outcome
Postoperative nausea and vomiting
Time frame: through study completion, an average of 24 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 3 Mar 2017.
- Results publication: PubMed 10485781Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.
- Results publication: PubMed 1989740Blanc VF, Ruest P, Milot J, Jacob JL, Tang A. Antiemetic prophylaxis with promethazine or droperidol in paediatric outpatient strabismus surgery. Can J Anaesth. 1991 Jan;38(1):54-60. doi: 10.1007/BF03009164.
- Results publication: PubMed 22110499Chatterjee S, Rudra A, Sengupta S. Current concepts in the management of postoperative nausea and vomiting. Anesthesiol Res Pract. 2011;2011:748031. doi: 10.1155/2011/748031. Epub 2011 Nov 3.
- Results publication: PubMed 20445713Doubravska L, Dostalova K, Fritscherova S, Zapletalova J, Adamus M. Incidence of postoperative nausea and vomiting in patients at a university hospital. Where are we today? Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2010 Mar;154(1):69-76. doi: 10.5507/bp.2010.012.
- Results publication: PubMed 22989590Jokinen J, Smith AF, Roewer N, Eberhart LH, Kranke P. Management of postoperative nausea and vomiting: how to deal with refractory PONV. Anesthesiol Clin. 2012 Sep;30(3):481-93. doi: 10.1016/j.anclin.2012.07.003. Epub 2012 Aug 14.
- Individual participant dataSharing planned: No
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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.
Sirirat Tribuddharat, MD principal investigator
Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea and Vomiting, run by Khon Kaen University at 1 site in Thailand.
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 3 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 3 Mar 2017. 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 Thailand. 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?
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: through study completion, an average of 24 hours). 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 NCT02944942, which also lists 5 linked publications.
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 3 Mar 2017.