Lower Esophageal SphincterPhase 4NCT01199458
The Effect of an Opioid on the Lower Esophageal Sphincter During Anesthesia Induction
A Phase 4 study testing alfentanil and saline in people with Lower Esophageal Sphincter, run by Region Örebro County at 1 site in Sweden.
Trial summary
This study evaluates the effects of adding an opioid (alfentanil) during anesthesia induction with respect to the barrierpressure in the esophagogastric junction. The secondary aim was to investigate whether the effect of cricoid pressure influences the barrierpressure. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Esophageal Sphincter
- What is being tested?
- alfentanil and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Oct 2010
- 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
- Healthy volunteer 18-40 years old
- Informed,signed and dated consent
Who cannot join
- Pharyngoesophageal dysfunction
- Gastro/intestinal-,cardiovascular-,lung- or neurologic disease
- Ongoing medication
- Allergy to alfentanil, propofol, soya or peanuts
- Pregnancy or breast-feeding
- BMI>30
- Participation in other clinical trial -ongoing or during last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Alfentanil on the Lower Esophageal Sphincter During Anesthesia Induction - a Study in Volunteers
This study evaluates the effects of adding an opioid (alfentanil) during anesthesia induction with respect to the barrierpressure in the esophagogastric junction.
The secondary aim was to investigate whether the effect of cricoid pressure influences the barrierpressure.
Read the detailed description
During anesthesia induction and tracheal intubation one major concern is to avoid passive regurgitation of gastric content and aspiration.
The lower esophageal sphincter is a muscle located at the distal end of the esophagus. It plays an important role in creating a barrier between the stomach and the esophagus. The term "barrierpressure" is defined as the pressure difference between the lower esophageal sphincter pressure and the pressure in the stomach (intragastric pressure).
There are studies showing that opioids given iv/im, in the vein or in the muscle, may decrease the pressure in the lower esophageal sphincter and hereby increase the risk of aspiration.
Nevertheless,other studies shows that opioids are still frequently given to patients during anesthesia induction. This is done in order to prevent the cardiovascular response to (the painful) intubation which can often be seen as an equally high risk for the patient as the risk of aspiration.
In light of the above description, the investigators are planning a study in volunteers with the primary aim of investigating the effects of an opioid (alfentanil) on the pressures in the lower esophageal sphincter.
Another safety measure taken during anesthesia induction is the so called "cricoid pressure". This is based on the theory that passive regurgitation of gastric content may be prevented by occluding the esophagus by pressing on the cricoid cartilage. However, there are studies indicating that the application of cricoid pressure also may decrease the tonus of the lower esophageal sphincter.
The secondary aim of the study is to investigate the effect of cricoid pressure application on the pressure in the lower esophageal sphincter.
Measurements are being done using high-resolution solid-state manometry.
- Conditions
- Lower Esophageal Sphincter
- Being tested
- alfentanil, saline
- Keywords
- Lower Esophageal Sphincter, Barrier pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alfentanilDrug
Also called alfentanil = rapifen
20 mikrogr/kg
salineDrug
The amount of saline will be equal the amount (in ml) of the study-drug (alfentanil)in order to keep it blinded.
| Study group | Role | What they receive |
|---|---|---|
| opioid | Active comparator | Preoxygenation for 5 min. Injection of opioid (alfentanil 20 mikrogr/kg iv) after 2 min:Injection of induction drug(propofol 2-2.5mg/kg) after anesthesia induction: Application of cricoid pressure for 15 sec. Receives: Drug: alfentanil |
| placebo | Placebo comparator | Preoxygenation for 5 min. Injection of saline iv. after 2 min:Injection of induction drug(propofol 2-2.5mg/kg) after anesthesia induction: Application of cricoid pressure for 15 sec. Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.
Pressure variations in the lower esophageal sphincter will be measured continuously during the whole study. Registrations will be saved in the computer-software. Predetermined time points will be marked on the registrations for later evaluation.
Measured: 1 min after the application of the induction agent (propofol)
Secondary outcomes (2)
Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.
Pressure variations in the lower esophageal sphincter will be measured continuously during the whole study. Registrations will be saved in the computer-software. Predetermined time points will be marked on the registrations for later evaluation.
Measured: during cricoidpressure application (continues for 15 sec)
Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.
Pressure variations in the lower esophageal sphincter will be measured continuously during the whole study. Registrations will be saved in the computer-software. Predetermined time points will be marked on the registrations for later evaluation.
Measured: 1min after the opioid/placebo injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Esophageal SphincterStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Wattwil, MD PhD, Principal investigator, Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199458
- Sponsor's protocol ID
- EudraCT nr: 2010-020697-41
- Status last verified
- Sep 2010
- First submitted
- 8 Sep 2010
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Original data can be available by contacting the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alfentanil on the Lower Esophageal Sphincter During Anesthesia Induction - a Study in Volunteers
- ClinicalTrials.gov ID
- NCT01199458
- Acronym / sponsor ID
- EudraCT nr: 2010-020697-41
- Conditions
- Lower Esophageal Sphincter
- Keywords
- Lower Esophageal Sphincter, Barrier pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 13 Sep 2010 (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.
This study evaluates the effects of adding an opioid (alfentanil) during anesthesia induction with respect to the barrierpressure in the esophagogastric junction.
The secondary aim was to investigate whether the effect of cricoid pressure influences the barrierpressure.
Detailed description
During anesthesia induction and tracheal intubation one major concern is to avoid passive regurgitation of gastric content and aspiration.
The lower esophageal sphincter is a muscle located at the distal end of the esophagus. It plays an important role in creating a barrier between the stomach and the esophagus. The term "barrierpressure" is defined as the pressure difference between the lower esophageal sphincter pressure and the pressure in the stomach (intragastric pressure).
There are studies showing that opioids given iv/im, in the vein or in the muscle, may decrease the pressure in the lower esophageal sphincter and hereby increase the risk of aspiration.
Nevertheless,other studies shows that opioids are still frequently given to patients during anesthesia induction. This is done in order to prevent the cardiovascular response to (the painful) intubation which can often be seen as an equally high risk for the patient as the risk of aspiration.
In light of the above description, the investigators are planning a study in volunteers with the primary aim of investigating the effects of an opioid (alfentanil) on the pressures in the lower esophageal sphincter.
Another safety measure taken during anesthesia induction is the so called "cricoid pressure". This is based on the theory that passive regurgitation of gastric content may be prevented by occluding the esophagus by pressing on the cricoid cartilage. However, there are studies indicating that the application of cricoid pressure also may decrease the tonus of the lower esophageal sphincter.
The secondary aim of the study is to investigate the effect of cricoid pressure application on the pressure in the lower esophageal sphincter.
Measurements are being done using high-resolution solid-state manometry.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid | Active comparator | Drug: alfentanilPreoxygenation for 5 min. Injection of opioid (alfentanil 20 mikrogr/kg iv) after 2 min:Injection of induction drug(propofol 2-2.5mg/kg) after anesthesia induction: Application of cricoid pressure for 15 sec. |
| placebo | Placebo comparator | Drug: salinePreoxygenation for 5 min. Injection of saline iv. after 2 min:Injection of induction drug(propofol 2-2.5mg/kg) after anesthesia induction: Application of cricoid pressure for 15 sec. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteer 18-40 years old
- Informed,signed and dated consent
Key exclusion criteria (7 listed)
- Pharyngoesophageal dysfunction
- Gastro/intestinal-,cardiovascular-,lung- or neurologic disease
- Ongoing medication
- Allergy to alfentanil, propofol, soya or peanuts
- Pregnancy or breast-feeding
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 |
|---|---|---|
| alfentanilAlso: alfentanil = rapifen20 mikrogr/kg | Drug | opioid |
| salineThe amount of saline will be equal the amount (in ml) of the study-drug (alfentanil)in order to keep it blinded. | Drug | placebo |
Primary outcome
Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.
Time frame: 1 min after the application of the induction agent (propofol)
Pressure variations in the lower esophageal sphincter will be measured continuously during the whole study. Registrations will be saved in the computer-software. Predetermined time points will be marked on the registrations for later evaluation.
2 secondary outcomes
Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.
Time frame: during cricoidpressure application (continues for 15 sec)
Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.
Time frame: 1min after the opioid/placebo injection
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 9 Nov 2016.
- Individual participant dataSharing planned: Yes. Original data can be available by contacting the principal investigator
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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.
Magnus Wattwil, MD PhD principal investigator
Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing alfentanil and saline in people with Lower Esophageal Sphincter, run by Region Örebro County at 1 site 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 2 inclusion and 7 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 9 Nov 2016. 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 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?
Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter. (time frame: 1 min after the application of the induction agent (propofol)). 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 9 Nov 2016.