The Effect of an Opioid on the Lower Esophageal Sphincter During Anesthesia Induction

Lower Esophageal Sphincter Clinical Trial

Official title:

The Effect of Alfentanil on the Lower Esophageal Sphincter During Anesthesia Induction - a Study in Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199458
• Other study ID #: EudraCT nr: 2010-020697-41
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2010
• Last updated: November 8, 2016
• Start date: September 2010
• Est. completion date: October 2010

Study information

• Verified date: September 2010
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Medical Products Agency
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Lower Esophageal Sphincter

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Sweden	Örebro University	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes
Secondary	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	Yes