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Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers

NCT ID: NCT01924234

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pharyngeal Dysfunction Pharyngeal Swallowing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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morphine

Volunteers are given morphine injection

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

remifentanil

Volunteers are given remifentanil infusion

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

Interventions

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Morphine

Intervention Type DRUG

Remifentanil

Intervention Type DRUG

Other Intervention Names

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ACT-code: N02AA01 Younger volunteers: injection 0.1 mg/kg Elderly volunteers: injections 0.07 mg/kg Ultiva ATC-code: N01AH06 Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 30 min ( 0,15 ug/kg/min)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Johanna Savilampi

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johanna Savilampi, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Intensive Care, Örebro University Hospital

Locations

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Örebro University Hospital

Örebro, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 27191923 (View on PubMed)

Other Identifiers

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JS004

Identifier Type: -

Identifier Source: org_study_id