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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alfentanil | Drug | 20 mikrogr/kg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 min after the application of the induction agent (propofol) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | during cricoidpressure application (continues for 15 sec) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magnus Wattwil, MD PhD | Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University | Örebro | 21740 | Sweden |
Original data can be available by contacting the principal investigator
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| ID | Term |
|---|---|
| D015760 | Alfentanil |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| saline | Drug | The amount of saline will be equal the amount (in ml) of the study-drug (alfentanil)in order to keep it blinded. |
|
| 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. | 1min after the opioid/placebo injection |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |