Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers

The purpose of the study is to determine whether remifentanil influence the pharyngeal phase of swallowing using using pressure and impedance recordings. The purpose is also to compare remifentanil to morphine and younger to elderly volunteers.

Study Overview

• Status: Completed
• Conditions: Pharyngeal Dysfunction; Pharyngeal Swallowing
• Intervention / Treatment: Drug: Morphine; Drug: Remifentanil

Detailed Description

Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in postoperative patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. In a previous study (not yet published) we showed that remifentanil induce pulmonary aspiration in healthy volunteers and the aim of this study is to objectively determine weather remifentanil infusion in healthy volunteers influence the pharyngeal phase of swallowing. The purpose is also compare the effect of remifentanil to morphine and younger volunteers to elderly volunteers. To assess this question we are going to study 24 volunteers, 12 younger and 12 elderly, who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 30 minutes at one occasion and an injection of morphine (younger: 0.1 mg/kg, elderly 0.07 mg/kg) at the other. The volunteers are asked to swallow 10 ml normal saline several times both before and after opioid administration and pharyngeal motility is parallelly recorded using combined manometry and impedance catheter placed transnasally into to the pharyngo-esophageal segment. Any subjective swallowing difficulties are also recorded.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 70185
    • Orebro University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-30 or 65 < 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
• Known history of cardiac, pulmonary or neurological disease
• Ongoing medication
• Allergies to or history of reaction to remifentanil, fentanyl analogues or other ingredients
• 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 complete.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: morphine; Volunteers are given morphine injection	Drug: Morphine; Other Names: ACT-code: N02AA01; Younger volunteers: injection 0.1 mg/kg; Elderly volunteers: injections 0.07 mg/kg
Active Comparator: remifentanil; Volunteers are given remifentanil infusion	Drug: Remifentanil; Other Names: Ultiva; ATC-code: N01AH06; Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 30 min ( 0,15 ug/kg/min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pressure-Flow Variables measured by combined manometry and impedance system ( ManoScan 360) during pharyngeal swallowing	up to 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection)

Secondary Outcome Measures

Outcome Measure	Time Frame
Subjective swallowing difficulties measured by 4-point scale	Variables are measured before (baseline) and 15 min and 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection)

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Principal Investigator: Johanna Savilampi, M.D, Department of Anesthesiology and Intensive Care, Örebro University Hospital

Publications and helpful links

General Publications

• Savilampi J, Omari T, Magnuson A, Ahlstrand R. Effects of remifentanil on pharyngeal swallowing: A double blind randomised cross-over study in healthy volunteers. Eur J Anaesthesiol. 2016 Sep;33(9):622-30. doi: 10.1097/EJA.0000000000000461.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 12, 2013
• First Submitted That Met QC Criteria: August 15, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Remifentanil; Pharyngeal dysfunction; Subjective swallowing difficulties; Pulmonary aspiration
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil; Morphine
• Other Study ID Numbers: JS004