Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration

Does Opioid Induced Swallowing Difficulty Lead to Elevated Risk for Pulmonary Aspiration?

The purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.

Study Overview

• Status: Completed
• Conditions: Opioid Induced Swallowing Disorders
• Intervention / Treatment: Drug: Remifentanil; Drug: Placebo; Drug: Technetium; Device: Dynamometer (Jamar)

Detailed Description

Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in icu-patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. In these circumstances inability to clear the pharynx by swallowing may increase risk for aspiration.In a previous study ( not yet published) we showed that remifentanil induce subjective swallowing difficulties in healthy volunteers and the aim of this study is to determine weather remifentanil infusion in healthy non-intubated volunteers increase risk for pulmonary aspiration. To assess this question we are going to study 14 volunteers who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 60 minutes at one occasion and an equal amount of saline at the other. Radioactive Technetium colloid solution is parallelly infused through a pliable catheter transnasally. After remifentanil infusion is stopped the transnasal catheter is removed and the volunteer is asked to swallow water to clear the remaining radioactivity from upper gastrointestinal tract. Thereafter lung scanning with a gamma camera is performed. Through which mechanism remifentanil cause swallowing difficulties is not known.To determine weather remifentanil induce general muscle weakness in volunteers measurements of grip strength using Jamar dynamometer are performed before, during and 15 minutes after remifentanil infusion.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70185
    • Orebro University Hospital
  • Örebro, Sweden, 701 85
    • University Hospital in Örebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 - 40 year old healthy volunteers from both sexes.
• Have signed and dated Informed Consent.
• Willing and able to comply with the protocol for the duration of the trial.

Exclusion Criteria:

• Pharyngoesophageal dysfunction
• Anamnesis of pharyngoesophageal dysfunction
• Known history of cardiac, pulmonary or neurological disease
• Ongoing medication
• Allergies to or history of reaction to naloxone, remifentanil, fentanyl analogues or other ingredients
• History of reaction to products containing human albumine
• Pregnancy or breast feeding
• BMI > 30
• Previous participation in a medical clinical trial where opioid has been used or have during last 30 days participated in any other medicinal clinical trial or in a trial where follow-up in not completed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Infusion fluid, solution 9 mg/ml ( hydrogenic solution ); Other Names: Saline; ACT-code: B05XA03
ACTIVE_COMPARATOR: Remifentanil	Drug: Remifentanil; Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min); Other Names: Ultiva; ATC-code: N01AH06
EXPERIMENTAL: Technetium	Drug: Technetium; 37-40 MBq( effective dose 0,7 mSv) 99Tc albumin colloid in a volume of 6 ml, infusion velocity 0,1 ml/min via a transnasal catheter; Other Names: Nanocol; ACT-code: V09DB01
EXPERIMENTAL: Dynamometer	Device: Dynamometer (Jamar); portable hydraulic hand dynamometer to assess grip strength.; Other Names: Jamar dynamometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radioactivity evident in lungs imaged using a gamma camera	one study occasion takes two hours and a gamma camera scan is taken in the end of the occasion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip strength measured with Jamar dynamometer	Jamar dynamometer is positioned in the dominant hand att maximal grip strength contraction is taken three times, the mean value is used for the analysis.	volunteers are studied during two hours during which grip strength is measured three times

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Study Chair: magnus wattwil, MD, PhD, University Hospital in Örebro

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: December 9, 2011
• First Submitted That Met QC Criteria: December 19, 2011
• First Posted (ESTIMATE): December 20, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): August 22, 2012
• Last Update Submitted That Met QC Criteria: August 21, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: remifentanil; scintigraphy; pulmonary aspiration; swallowing difficulties
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: JS003