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Completed

NCT Number: NCT01199458

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Örebro University

Örebro, 21740, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

alfentanil

Drug

20 mikrogr/kg

Other names: alfentanil = rapifen

Saline

Drug

The amount of saline will be equal the amount (in ml) of the study-drug (alfentanil)in order to keep it blinded.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.

    Time frame: during cricoidpressure application (continues for 15 sec)

    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. Changes in barrierpressure (in mmHg) in the area of the lower esophageal sphincter.

    Time frame: 1min after the opioid/placebo injection

    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.

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 13, 2010
Registry last updated
Nov 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.