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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University Hospital Orebro.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01199458
First received: September 8, 2010
Last updated: September 10, 2010
Last verified: September 2010

September 8, 2010
September 10, 2010
September 2010
October 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01199458 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effect of an Opioid on the Lower Esophageal Sphincter During Anesthesia Induction
The Effect of Alfentanil on the Lower Esophageal Sphincter During Anesthesia Induction - a Study in Volunteers

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Lower Esophageal Sphincter
  • Drug: alfentanil
    20 mikrogr/kg
    Other Name: alfentanil = rapifen
  • 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
  • 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.
    Intervention: Drug: alfentanil
  • 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.
    Intervention: Drug: saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact: Rebecca Ahlstrand, MD +46196021000 rebecca.ahlstrand@orebroll.se
Contact: Sven-Egron Thörn, MD PhD +46196021000 sven-egron.thorn@orebroll.se
Sweden
 
NCT01199458
EudraCT nr: 2010-020697-41
Yes
Magnus Wattwil MD PhD, Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden
University Hospital Orebro
Not Provided
Principal Investigator: Magnus Wattwil, MD PhD Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden
University Hospital Orebro
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP