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

NCT01199458 | Completed Phase 4 DMC

• 1 other identifier: EudraCT nr: 2010-020697-41
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Esophageal Sphincter

Keywords

Lower Esophageal Sphincter; Barrier pressure

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

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

  during cricoidpressure application (continues for 15 sec)

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

  1min after the opioid/placebo injection

Study Arms (2)

opioid

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

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

Interventions

alfentanil DRUG

20 mikrogr/kg

Also known as: alfentanil = rapifen

opioid

saline DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteer 18-40 years old
• Informed,signed and dated consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Örebro University

Örebro, 21740, Sweden

Location

MeSH Terms

Interventions

Alfentanil; Sodium Chloride

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Magnus Wattwil, MD PhD

  Department of Anesthesia and Intensive Care, Örebro University Hospital, Örebro,Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: September 13, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 9, 2016

Record last verified: 2010-09

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)