Post-operative Patients Treated by TramadolCYTRAMNCT00952159
CYTRAM (Cytochrome P450, Tramadol)
An observational study of Post-operative Patients Treated by Tramadol, run by University Hospital, Caen at 4 sites in France.
Trial summary
Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on genotyping. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Patients Treated by Tramadol
- What is being tested?
- Monitoring seric concentrations of O-demethyl-tramadol and tramadol
- How many people
- 301 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2010to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post-operative patients treated by tramadol
Who may be able to join
- age > 18 years, post-operative patient treated with intravenous tramadol
- Caucasian origin
- take of blood at H24 and H48 in the post-operative monitoring
Who cannot join
- patient having already been included in the study
- patient taking opioid drugs before surgery
- patient taking one or more drugs inhibiting the CYP2D6 before or during surgery
- pregnancy or breast feeding patients having one or more contraindications for taking tramadol in post-operative analgesia
- hepatocellular incapacity (TP < 70%)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Private Clinic Saint-Martin
Caen, 14000
Caen University Hospital
Caen, 14033
Créteil University Hospital
Créteil
Rouen University Hospital
Rouen, 76000
About this study
Official title: Validation of a New Method to Detect CYP2D6 Poor Metabolizers by Monitoring Seric Concentrations of O-demethyl-tramadol and Tramadol to Make a Ratio in Comparison With Genotyping in Post-operative Patients Treated With Intravenous Tramadol
Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on genotyping. Up to now, CYP2D6 pharmacogenetics has been restricted to the field of research, in spite of poor metabolizer profile concerns 5 to 10 % of caucasian population. Nevertheless, the polymorphism of CYP2D6 is responsible for the metabolism of many drugs, particularly of two opioids involved in pain management: codeine and tramadol, their metabolites representing the most effective part of the drug effect. So prescribing codeine or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain management.
O-demethyl-tramadol, the metabolite of tramadol via CYP2D6, is important to consider because its analgesic effect is 2 to 4 times more potent than tramadol.
Read more
The investigators propose to phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype, and to find a threshold to determine poor metabolizers. As already described, genotyping CYP2D6 will use a rapid detection method of the alleles implicated in poor metabolizer status (CYP2D6*3, *4, *5 et *6) in a Caucasian population. Sampling will be executed at two times (H24 and H48 after surgery) and only with blood (three EDTA tubes) during the post-operative monitoring of the patients. This study is likely to include 320 post-operative patients treated with intravenous tramadol during one year in three university hospitals centers (CHU of Caen, Creteil and Rouen).
The first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response, this method should be liked to improve pain management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.
- Being tested
- Monitoring seric concentrations of O-demethyl-tramadol and tramadol
- Keywords
- tramadol, CYP2D6, O-demethyl-tramadol, poor metabolizer, genotyping, phenotyping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring seric concentrations of O-demethyl-tramadol and tramadolBiological
The first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response, this method should be liked to improve pain management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.
| Study group | Role | What they receive |
|---|---|---|
| Not Poor metabolizer | Not described Receives: Biological: Monitoring seric concentrations of O-demethyl-tramadol and tramadol | |
| Poor metabolizer | Not described Receives: Biological: Monitoring seric concentrations of O-demethyl-tramadol and tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype, and to find a threshold to determine poor metabolizers.
Measured: H24 and H48 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 Aug 2009 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionJun 2011
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 Post-operative Patients Treated by TramadolStudies 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
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Investigators
- Blandine de la Gastine, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952159
- Sponsor's protocol ID
- 2009-A00380-57
- Other IDs
- 09-013
- Acronym
- CYTRAM
- Status last verified
- Jul 2011
- First submitted
- 3 Aug 2009
- Last updated
- 4 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Percevault S, De La Gastine B, Varin L, Richard N, Fobe F, Plaud B, Daccache G, Compere V, Parienti JJ, Coquerel A, Loilier M, Bleyzac N, Bourguignon L, Lelong-Boulouard V, Goutelle S. Influence of CYP2D6 phenotype on the pharmacokinetics and pharmacodynamics of tramadol in patients treated for post-operative pain management. Anaesth Crit Care Pain Med. 2026 May;45(3):101781. doi: 10.1016/j.accpm.2026.101781. Epub 2026 Mar 4.
PubMed 41791456
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Method to Detect CYP2D6 Poor Metabolizers by Monitoring Seric Concentrations of O-demethyl-tramadol and Tramadol to Make a Ratio in Comparison With Genotyping in Post-operative Patients Treated With Intravenous Tramadol
- ClinicalTrials.gov ID
- NCT00952159
- Acronym / sponsor ID
- CYTRAM / 2009-A00380-57
- Keywords
- tramadol, CYP2D6, O-demethyl-tramadol, poor metabolizer, genotyping, phenotyping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Aug 2009 (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.
Many methods to detect CYP2D6 poor metabolizers have been validated. Some of them are based on phenotyping (metabolism of dextromethorphan or debrisoquine) and some others on genotyping. Up to now, CYP2D6 pharmacogenetics has been restricted to the field of research, in spite of poor metabolizer profile concerns 5 to 10 % of caucasian population. Nevertheless, the polymorphism of CYP2D6 is responsible for the metabolism of many drugs, particularly of two opioids involved in pain management: codeine and tramadol, their metabolites representing the most effective part of the drug effect. So prescribing codeine or tramadol in a patient poor metabolizer for the CYP2D6 is likely to be ineffective in pain management.
O-demethyl-tramadol, the metabolite of tramadol via CYP2D6, is important to consider because its analgesic effect is 2 to 4 times more potent than tramadol.
The investigators propose to phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype, and to find a threshold to determine poor metabolizers. As already described, genotyping CYP2D6 will use a rapid detection method of the alleles implicated in poor metabolizer status (CYP2D6*3, *4, *5 et *6) in a Caucasian population. Sampling will be executed at two times (H24 and H48 after surgery) and only with blood (three EDTA tubes) during the post-operative monitoring of the patients. This study is likely to include 320 post-operative patients treated with intravenous tramadol during one year in three university hospitals centers (CHU of Caen, Creteil and Rouen).
The first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response, this method should be liked to improve pain management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Not Poor metabolizer | – | Biological: Monitoring seric concentrations of O-demethyl-tramadol and tramadol |
| Poor metabolizer | – | Biological: Monitoring seric concentrations of O-demethyl-tramadol and tramadol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-operative patients treated by tramadol
Key inclusion criteria (3 listed)
- age > 18 years, post-operative patient treated with intravenous tramadol
- Caucasian origin
- take of blood at H24 and H48 in the post-operative monitoring
Key exclusion criteria (5 listed)
- patient having already been included in the study
- patient taking opioid drugs before surgery
- patient taking one or more drugs inhibiting the CYP2D6 before or during surgery
- pregnancy or breast feeding patients having one or more contraindications for taking tramadol in post-operative analgesia
- hepatocellular incapacity (TP < 70%)
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 |
|---|---|---|
| Monitoring seric concentrations of O-demethyl-tramadol and tramadolThe first aim of this study is the validation of monitoring seric concentrations of O-demethyl-tramadol and tramadol to make the ratio in order to detect CYP2D6 poor metabolizers in therapeutic situation, comparing the result with genotyping. The finding of a poor metabolizer status in a patient will make the choice of analgesic drugs easier, avoiding tramadol and codeine. The final objective of this research is to be able to determine the CYP2D6 phenotype in a patient treated by tramadol without a good analgesia. By a single take of blood and a rapid response, this method should be liked to improve pain management. Furthermore, CYP2D6 phenotyping is interesting for the patient because many other drugs depend on this way of metabolism. | Biological | Not Poor metabolizer, Poor metabolizer |
Primary outcome
To phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype, and to find a threshold to determine poor metabolizers.
Time frame: H24 and H48 after surgery
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 4 Jul 2011.
- Derived from this study: PubMed 41791456Percevault S, De La Gastine B, Varin L, Richard N, Fobe F, Plaud B, Daccache G, Compere V, Parienti JJ, Coquerel A, Loilier M, Bleyzac N, Bourguignon L, Lelong-Boulouard V, Goutelle S. Influence of CYP2D6 phenotype on the pharmacokinetics and pharmacodynamics of tramadol in patients treated for post-operative pain management. Anaesth Crit Care Pain Med. 2026 May;45(3):101781. doi: 10.1016/j.accpm.2026.101781. Epub 2026 Mar 4.
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.
Blandine de la Gastine, MD principal investigator
University Hospital, Caen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Patients Treated by Tramadol, run by University Hospital, Caen at 4 sites in France.
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 3 inclusion and 5 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 4 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
To phenotype CYP2D6 in post-operative patients treated by tramadol by monitoring seric concentrations of O-demethyl tramadol and tramadol to make a ratio in comparison with genotype, and to find a threshold to determine poor metabolizers. (time frame: H24 and H48 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 NCT00952159, 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 4 Jul 2011.