Current SmokersNCT02266212
A Study on Analgesia and Related Outcomes for Patients With Tabacco Smoking
A study testing 5 ml arterial blood in people with Current Smokers and Past Smokers, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among current, past and non smokers are determined by comparing and analyzing frequency distributions. To determine whether smokers require more post operative opiate analgesics than others. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Current Smokers, Past Smokers, Never Smokers
- What is being tested?
- 5 ml arterial blood
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2011to Sep 2012
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing elective general surgery are assigned to current smokers（n=100） or past smokers（n=100） or never smokers（n=100） according to the questionnaires "Fagerstrom test for nicotine dependence" 1 day prior to the surgery.
Who cannot join
- the patients undergoing major thoracic cardiovascular surgery
- the patients with significant lung lesion
- the patients with conscious disturbance
- the patients with allergic history to morphine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Implications of Tobacco Smoking on Acute Postoperative Pain: A Prospective Observational Study
Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among current, past and non smokers are determined by comparing and analyzing frequency distributions. To determine whether smokers require more post operative opiate analgesics than others. Multivariate analysis will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. Our previous related study showed that the smoker male patients consumed more analgesics than those without smoking, but the female group showed the similar findings. However, the case number, especially the female cases, is underpowered. Investigators hope to increase the case number to have a better statistical and clinical significance.
- Conditions
- Current Smokers, Past Smokers, Never Smokers
- Being tested
- 5 ml arterial blood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 ml arterial bloodProcedure or surgery
A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).
| Study group | Role | What they receive |
|---|---|---|
| Smoke | Active comparator | Fagerstrom test for nicotine dependence Receives: Procedure: 5 ml arterial blood |
| Pain | Active comparator | pain during post-operation Day1 to Day4 Receives: Procedure: 5 ml arterial blood |
| Morphine | Active comparator | Morphine consumption during post-operation Day1 to Day4 Receives: Procedure: 5 ml arterial blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fagerstrom test for nicotine dependence
Measured: Post-operation Day1 to Day4
Secondary outcomes (1)
Differences in pain intensity between the three groups after postoperative analgesia.
Patients will give a pain score from 0 to 10. 10 is the most painful score.
Measured: Post-operation Day1 to Day4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Current SmokersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Yi Chia, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266212
- Sponsor's protocol ID
- VGHKS101-016
- Status last verified
- Oct 2023
- First submitted
- 10 Sep 2014
- Last updated
- 27 Oct 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implications of Tobacco Smoking on Acute Postoperative Pain: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02266212
- Acronym / sponsor ID
- VGHKS101-016
- Conditions
- Current Smokers, Past Smokers, Never Smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Oct 2014 (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.
Numbers of postoperative PCA(Patient-Controlled Analgesia) related side effects among current, past and non smokers are determined by comparing and analyzing frequency distributions. To determine whether smokers require more post operative opiate analgesics than others. Multivariate analysis will be performed to identify the major and the minor factors predicting the use of postoperative pain therapy. Our previous related study showed that the smoker male patients consumed more analgesics than those without smoking, but the female group showed the similar findings. However, the case number, especially the female cases, is underpowered. Investigators hope to increase the case number to have a better statistical and clinical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Smoke | Active comparator | Procedure: 5 ml arterial bloodFagerstrom test for nicotine dependence |
| Pain | Active comparator | Procedure: 5 ml arterial bloodpain during post-operation Day1 to Day4 |
| Morphine | Active comparator | Procedure: 5 ml arterial bloodMorphine consumption during post-operation Day1 to Day4 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective general surgery are assigned to current smokers（n=100） or past smokers（n=100） or never smokers（n=100） according to the questionnaires "Fagerstrom test for nicotine dependence" 1 day prior to the surgery.
Key exclusion criteria (4 listed)
- the patients undergoing major thoracic cardiovascular surgery
- the patients with significant lung lesion
- the patients with conscious disturbance
- the patients with allergic history to morphine
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 ml arterial bloodA sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg). | Procedure or surgery | Morphine, Pain, Smoke |
Primary outcome
Fagerstrom test for nicotine dependence
Time frame: Post-operation Day1 to Day4
1 secondary outcome
Differences in pain intensity between the three groups after postoperative analgesia.
Time frame: Post-operation Day1 to Day4
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 27 Oct 2023.
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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 5 ml arterial blood in people with Current Smokers and Past Smokers, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 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: finished, as of the sponsor's last update on 27 Oct 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 Taiwan. 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?
Fagerstrom test for nicotine dependence (time frame: Post-operation Day1 to Day4). 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 27 Oct 2023.