Opioid Induced Swallowing DisordersPhase 4NCT01495377
Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration
A Phase 4 study testing Remifentanil, Technetium and Dynamometer (Jamar) in people with Opioid Induced Swallowing Disorders, run by Region Örebro County at 2 sites in Sweden.
Trial summary
The purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Induced Swallowing Disorders
- What is being tested?
- Remifentanil, Technetium and Dynamometer (Jamar)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2012to May 2012
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 40 year old healthy volunteers from both sexes.
- Have signed and dated Informed Consent.
- Willing and able to comply with the protocol for the duration of the trial.
Who cannot join
- Pharyngoesophageal dysfunction
- Anamnesis of pharyngoesophageal dysfunction
- Known history of cardiac, pulmonary or neurological disease
- Ongoing medication
- Allergies to or history of reaction to naloxone, remifentanil, fentanyl analogues or other ingredients
- History of reaction to products containing human albumine
Show all 9Show fewer
- Pregnancy or breast feeding
- BMI > 30
- Previous participation in a medical clinical trial where opioid has been used or have during last 30 days participated in any other medicinal clinical trial or in a trial where follow-up in not completed
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
University Hospital in Örebro
Örebro, 701 85
Örebro University Hospital
Örebro, 70185
About this study
Official title: Does Opioid Induced Swallowing Difficulty Lead to Elevated Risk for Pulmonary Aspiration?
The purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.
Read the detailed description
Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in icu-patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. In these circumstances inability to clear the pharynx by swallowing may increase risk for aspiration.In a previous study ( not yet published) we showed that remifentanil induce subjective swallowing difficulties in healthy volunteers and the aim of this study is to determine weather remifentanil infusion in healthy non-intubated volunteers increase risk for pulmonary aspiration. To assess this question we are going to study 14 volunteers who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 60 minutes at one occasion and an equal amount of saline at the other. Radioactive Technetium colloid solution is parallelly infused through a pliable catheter transnasally. After remifentanil infusion is stopped the transnasal catheter is removed and the volunteer is asked to swallow water to clear the remaining radioactivity from upper gastrointestinal tract. Thereafter lung scanning with a gamma camera is performed. Through which mechanism remifentanil cause swallowing difficulties is not known.To determine weather remifentanil induce general muscle weakness in volunteers measurements of grip strength using Jamar dynamometer are performed before, during and 15 minutes after remifentanil infusion.
- Conditions
- Opioid Induced Swallowing Disorders
- Being tested
- Remifentanil, Placebo, Technetium, Dynamometer (Jamar)
- Keywords
- swallowing difficulties, remifentanil, pulmonary aspiration, scintigraphy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva, ATC-code: N01AH06
Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)
PlaceboDrug
Also called Saline, ACT-code: B05XA03
Infusion fluid, solution 9 mg/ml ( hydrogenic solution )
TechnetiumDrug
Also called Nanocol, ACT-code: V09DB01
37-40 MBq( effective dose 0,7 mSv) 99Tc albumin colloid in a volume of 6 ml, infusion velocity 0,1 ml/min via a transnasal catheter
Dynamometer (Jamar)Device
Also called Jamar dynamometer
portable hydraulic hand dynamometer to assess grip strength.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Active comparator | Not described Receives: Drug: Remifentanil |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Technetium | Experimental | Not described Receives: Drug: Technetium |
| Dynamometer | Experimental | Not described Receives: Device: Dynamometer (Jamar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactivity evident in lungs imaged using a gamma camera
Measured: one study occasion takes two hours and a gamma camera scan is taken in the end of the occasion
Secondary outcomes (1)
Grip strength measured with Jamar dynamometer
Jamar dynamometer is positioned in the dominant hand att maximal grip strength contraction is taken three times, the mean value is used for the analysis.
Measured: volunteers are studied during two hours during which grip strength is measured three times
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Induced Swallowing DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johanna Savilampi, Region Örebro County
- Investigators
- magnus wattwil, MD, PhD, Study chair, University Hospital in Örebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495377
- Sponsor's protocol ID
- JS003
- Status last verified
- Aug 2012
- First submitted
- 9 Dec 2011
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Opioid Induced Swallowing Difficulty Lead to Elevated Risk for Pulmonary Aspiration?
- ClinicalTrials.gov ID
- NCT01495377
- Acronym / sponsor ID
- JS003
- Conditions
- Opioid Induced Swallowing Disorders
- Keywords
- swallowing difficulties, remifentanil, pulmonary aspiration, scintigraphy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Dec 2011 (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 purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.
Detailed description
Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in icu-patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. In these circumstances inability to clear the pharynx by swallowing may increase risk for aspiration.In a previous study ( not yet published) we showed that remifentanil induce subjective swallowing difficulties in healthy volunteers and the aim of this study is to determine weather remifentanil infusion in healthy non-intubated volunteers increase risk for pulmonary aspiration. To assess this question we are going to study 14 volunteers who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 60 minutes at one occasion and an equal amount of saline at the other. Radioactive Technetium colloid solution is parallelly infused through a pliable catheter transnasally. After remifentanil infusion is stopped the transnasal catheter is removed and the volunteer is asked to swallow water to clear the remaining radioactivity from upper gastrointestinal tract. Thereafter lung scanning with a gamma camera is performed. Through which mechanism remifentanil cause swallowing difficulties is not known.To determine weather remifentanil induce general muscle weakness in volunteers measurements of grip strength using Jamar dynamometer are performed before, during and 15 minutes after remifentanil infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Active comparator | Drug: Remifentanil |
| Placebo | Placebo comparator | Drug: Placebo |
| Technetium | Experimental | Drug: Technetium |
| Dynamometer | Experimental | Device: Dynamometer (Jamar) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 - 40 year old healthy volunteers from both sexes.
- Have signed and dated Informed Consent.
- Willing and able to comply with the protocol for the duration of the trial.
Key exclusion criteria (9 listed)
- Pharyngoesophageal dysfunction
- Anamnesis of pharyngoesophageal dysfunction
- Known history of cardiac, pulmonary or neurological disease
- Ongoing medication
- Allergies to or history of reaction to naloxone, remifentanil, fentanyl analogues or other ingredients
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 |
|---|---|---|
| RemifentanilAlso: Ultiva, ATC-code: N01AH06Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min) | Drug | Remifentanil |
| PlaceboAlso: Saline, ACT-code: B05XA03Infusion fluid, solution 9 mg/ml ( hydrogenic solution ) | Drug | Placebo |
| TechnetiumAlso: Nanocol, ACT-code: V09DB0137-40 MBq( effective dose 0,7 mSv) 99Tc albumin colloid in a volume of 6 ml, infusion velocity 0,1 ml/min via a transnasal catheter | Drug | Technetium |
| Dynamometer (Jamar)Also: Jamar dynamometerportable hydraulic hand dynamometer to assess grip strength. | Device | Dynamometer |
Primary outcome
Radioactivity evident in lungs imaged using a gamma camera
Time frame: one study occasion takes two hours and a gamma camera scan is taken in the end of the occasion
1 secondary outcome
Grip strength measured with Jamar dynamometer
Time frame: volunteers are studied during two hours during which grip strength is measured three times
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 22 Aug 2012.
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.
magnus wattwil, MD, PhD study chair
University Hospital in Örebro
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil, Technetium and Dynamometer (Jamar) in people with Opioid Induced Swallowing Disorders, run by Region Örebro County at 2 sites in Sweden.
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 9 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 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Radioactivity evident in lungs imaged using a gamma camera (time frame: one study occasion takes two hours and a gamma camera scan is taken in the end of the occasion). 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 22 Aug 2012.