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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01199458
First Posted: September 13, 2010
Last Update Posted: November 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Region Örebro County
  Purpose

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.


Condition Intervention Phase
Lower Esophageal Sphincter Drug: alfentanil Drug: saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Alfentanil on the Lower Esophageal Sphincter During Anesthesia Induction - a Study in Volunteers

Resource links provided by NLM:


Further study details as provided by Region Örebro County:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.


Enrollment: 17
Study Start Date: September 2010
Study Completion Date: October 2010
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.

Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199458


Locations
Sweden
Örebro University
Örebro, Sweden, 21740
Sponsors and Collaborators
Region Örebro County
Investigators
Principal Investigator: Magnus Wattwil, MD PhD Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden
  More Information

Responsible Party: Region Örebro County
ClinicalTrials.gov Identifier: NCT01199458     History of Changes
Other Study ID Numbers: EudraCT nr: 2010-020697-41
First Submitted: September 8, 2010
First Posted: September 13, 2010
Last Update Posted: November 9, 2016
Last Verified: September 2010
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Original data can be available by contacting the principal investigator

Keywords provided by Region Örebro County:
Lower Esophageal Sphincter
Barrier pressure

Additional relevant MeSH terms:
Anesthetics
Alfentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General