HypothermiaNCT03122665
Effectiveness of Nefopam for Thermoregulation During Surgery
A study testing Nefopam Low dose and Nefopam High dose in people with Hypothermia, run by The Cleveland Clinic at 1 site in Switzerland.
Trial summary
Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypothermia
- What is being tested?
- Nefopam Low dose and Nefopam High dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2004to Jan 2006
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy volunteers ages 18-40
Who cannot join
- history of alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anesthesiology, University of Bern
Bern, Freiburgstrasses, 3010
About this study
Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia
Read the detailed description
Hypothermia, whether therapeutically induced or unintentional, triggers thermoregulatory defenses including vasoconstriction and shivering. Nefopam, a non-opioid, nonsteroidal centrally acting analgesic, has an opioid-sparing effect and anti-shivering potency without sedation, making it an ideal candidate to counteract thermoregulatory shivering.
Since complete compartmental pharmacokinetics (PK) are lacking this prospective, randomized, double-blind study in 8 volunteers was set to investigate the PK of arterial nefopam samples with non-linear mixed effect modelling. A two compartment mammillary model independent of covariates was found to describe the data best and could be implemented to drive automated pumps, achieving and maintaining a desired plasma concentration.
- Conditions
- Hypothermia
- Being tested
- Nefopam Low dose, Nefopam High dose
- Keywords
- Nefopam, Pharmacokinetics, Shivering,, Thermoregulation, Anesthesia
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nefopam Low doseDrug
Also called Low
Continuous intravenous infusion at 0.5 mg/ml for three hours.
Nefopam High doseDrug
Also called High
Continuous intravenous infusion at 1.0 mg/ml for three hours.
| Study group | Role | What they receive |
|---|---|---|
| Nefopam low dose | Active comparator | Nefopam continuous intravenous infusion at 0.5 mg/ml for three hours. Receives: Drug: Nefopam Low dose |
| Nefopam high dose | Active comparator | Nefopam continuous intravenous infusion at 1.0 mg/ml for three hours. Receives: Drug: Nefopam High dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
V1
Volume of distribution 1
Measured: three hours of infusion
V2
Volume of distribution2
Measured: three hours of infusion
CLel
Clearance
Measured: three hours of infusion
CLdist
Clearance distribution
Measured: three hours of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startAug 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- Volunteers given two doses of nefopam in a crossover protocol.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoires Biocodex (Montrouge, France)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122665
- Sponsor's protocol ID
- 180/03
- Status last verified
- Jun 2020
- First submitted
- 26 Oct 2016
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nefopam for Thermoregulation During Surgery
- ClinicalTrials.gov ID
- NCT03122665
- Acronym / sponsor ID
- 180/03
- Conditions
- Hypothermia
- Keywords
- Nefopam, Pharmacokinetics, Shivering,, Thermoregulation, Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Laboratoires Biocodex (Montrouge, France)
- Study start
- Aug 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 21 Apr 2017 (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.
Nefopam may help blunt thermoregulatory defenses, thus facilitating induction of therapeutic hypothermia
Detailed description
Hypothermia, whether therapeutically induced or unintentional, triggers thermoregulatory defenses including vasoconstriction and shivering. Nefopam, a non-opioid, nonsteroidal centrally acting analgesic, has an opioid-sparing effect and anti-shivering potency without sedation, making it an ideal candidate to counteract thermoregulatory shivering.
Since complete compartmental pharmacokinetics (PK) are lacking this prospective, randomized, double-blind study in 8 volunteers was set to investigate the PK of arterial nefopam samples with non-linear mixed effect modelling. A two compartment mammillary model independent of covariates was found to describe the data best and could be implemented to drive automated pumps, achieving and maintaining a desired plasma concentration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Volunteers given two doses of nefopam in a crossover protocol.
| Arm | Type | Receives |
|---|---|---|
| Nefopam low dose | Active comparator | Drug: Nefopam Low doseNefopam continuous intravenous infusion at 0.5 mg/ml for three hours. |
| Nefopam high dose | Active comparator | Drug: Nefopam High doseNefopam continuous intravenous infusion at 1.0 mg/ml for three hours. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal healthy volunteers ages 18-40
Key exclusion criteria (1 listed)
- history of alcohol or drug abuse
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 |
|---|---|---|
| Nefopam Low doseAlso: LowContinuous intravenous infusion at 0.5 mg/ml for three hours. | Drug | Nefopam low dose |
| Nefopam High doseAlso: HighContinuous intravenous infusion at 1.0 mg/ml for three hours. | Drug | Nefopam high dose |
Primary outcome
V1
Time frame: three hours of infusion
Volume of distribution 1
V2
Time frame: three hours of infusion
Volume of distribution2
CLel
Time frame: three hours of infusion
Clearance
CLdist
Time frame: three hours of infusion
Clearance distribution
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 18 Jun 2020.
- 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.
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 Nefopam Low dose and Nefopam High dose in people with Hypothermia, run by The Cleveland Clinic at 1 site in Switzerland.
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 1 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 18 Jun 2020. 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 Switzerland. 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?
V1 (time frame: three hours of infusion). The study lists 4 primary outcomes in all. 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 18 Jun 2020.