The Effect of an Opioid on the Lower Esophageal Sphincter During Anesthesia Induction
NCT ID: NCT01199458
Last Updated: 2016-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
17 participants
INTERVENTIONAL
2010-09-30
2010-10-31
Brief Summary
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The secondary aim was to investigate whether the effect of cricoid pressure influences the barrierpressure.
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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opioid
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.
alfentanil
20 mikrogr/kg
placebo
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.
saline
The amount of saline will be equal the amount (in ml) of the study-drug (alfentanil)in order to keep it blinded.
Interventions
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alfentanil
20 mikrogr/kg
saline
The amount of saline will be equal the amount (in ml) of the study-drug (alfentanil)in order to keep it blinded.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed,signed and dated consent
Exclusion Criteria
* 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.
18 Years
40 Years
ALL
Yes
Sponsors
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Region Örebro County
OTHER
Responsible Party
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Principal Investigators
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Magnus Wattwil, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden
Locations
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Örebro University
Örebro, , Sweden
Countries
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Other Identifiers
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EudraCT nr: 2010-020697-41
Identifier Type: -
Identifier Source: org_study_id