Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration

NCT ID: NCT01495377

Last Updated: 2012-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-05-31

Brief Summary

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

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.

Conditions

Opioid Induced Swallowing Disorders

Keywords

swallowing difficulties; remifentanil; pulmonary aspiration; scintigraphy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Remifentanil

Group Type: ACTIVE_COMPARATOR

Remifentanil

Intervention Type: DRUG

Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Infusion fluid, solution 9 mg/ml ( hydrogenic solution )

Technetium

Group Type: EXPERIMENTAL

Technetium

Intervention Type: DRUG

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

Dynamometer

Group Type: EXPERIMENTAL

Dynamometer (Jamar)

Intervention Type: DEVICE

portable hydraulic hand dynamometer to assess grip strength.

Interventions

Remifentanil

Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)

Intervention Type: DRUG

Placebo

Infusion fluid, solution 9 mg/ml ( hydrogenic solution )

Intervention Type: 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

Intervention Type: DRUG

Dynamometer (Jamar)

portable hydraulic hand dynamometer to assess grip strength.

Intervention Type: DEVICE

Other Intervention Names

Ultiva; ATC-code: N01AH06; Saline; ACT-code: B05XA03; Nanocol; ACT-code: V09DB01; Jamar dynamometer

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Johanna Savilampi

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

magnus wattwil, MD, PhD

Role: STUDY_CHAIR

University Hospital in Örebro

Locations

University Hospital in Örebro

Örebro, , Sweden

Örebro University Hospital

Örebro, , Sweden

Countries

Sweden

Other Identifiers

JS003

Identifier Type: -

Identifier Source: org_study_id