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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
  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

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

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) ] [ 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.


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) ] [ 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199458

Contacts
Contact: Rebecca Ahlstrand, MD +46196021000 rebecca.ahlstrand@orebroll.se
Contact: Sven-Egron Thörn, MD PhD +46196021000 sven-egron.thorn@orebroll.se

Locations
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         
Sponsors and Collaborators
University Hospital Orebro
Investigators
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:
Alfentanil
Anesthetics
Analgesics
Analgesics, Opioid
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014