The Effect of an Opioid on the Lower Esophageal Sphincter During Anesthesia Induction
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lower Esophageal Sphincter |
Drug: alfentanil Drug: saline |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Effect of Alfentanil on the Lower Esophageal Sphincter During Anesthesia Induction - a Study in Volunteers |
- 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) ] [ Designated as safety issue: Yes ]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.
- Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter. [ Time Frame: during cricoidpressure application (continues for 15 sec) ] [ Designated as safety issue: Yes ]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.
- Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter. [ Time Frame: 1min after the opioid/placebo injection ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 16 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 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.
|
Drug: alfentanil
20 mikrogr/kg
Other Name: alfentanil = rapifen
|
|
Placebo Comparator: 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.
|
Drug: saline
The amount of saline will be equal the amount (in ml) of the study-drug (alfentanil)in order to keep it blinded.
Other Name: saline
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy volunteer 18-40 years old
- Informed,signed and dated consent
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: Rebecca Ahlstrand, MD | +46196021000 | rebecca.ahlstrand@orebroll.se |
| Contact: Sven-Egron Thörn, MD PhD | +46196021000 | sven-egron.thorn@orebroll.se |
| Sweden | |
| Örebro University | Recruiting |
| Örebro, Sweden, 21740 | |
| Contact: Rebecca Ahlstrand, MD +46196021000 rebecca.ahlstrand@orebroll.se | |
| Contact: SvenEgron Thörn, MD,PhD +46196021000 sven-egron.thorn@orebroll.se | |
| Sub-Investigator: Rebecca Ahlstrand, MD | |
| Sub-Investigator: Sven-Egron Thörn, MD PhD | |
| Principal Investigator: | Magnus Wattwil, MD PhD | Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden |
More Information
No publications provided
| Responsible Party: | Magnus Wattwil MD PhD, Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden |
| ClinicalTrials.gov Identifier: | NCT01199458 History of Changes |
| Other Study ID Numbers: | EudraCT nr: 2010-020697-41 |
| Study First Received: | September 8, 2010 |
| Last Updated: | September 10, 2010 |
| Health Authority: | Sweden: Regional Ethical Review Board Sweden: Medical Products Agency |
Keywords provided by University Hospital Orebro:
|
Lower Esophageal Sphincter Barrier pressure |
Additional relevant MeSH terms:
|
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Alfentanil Analgesics, Opioid Anesthetics Narcotics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anesthetics, Intravenous Anesthetics, General |
ClinicalTrials.gov processed this record on May 22, 2013