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Completed

NCT Number: NCT01924234

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Örebro University Hospital

Örebro, 70185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morphine

Drug

Other names: ACT-code: N02AA01, Younger volunteers: injection 0.1 mg/kg, Elderly volunteers: injections 0.07 mg/kg

Remifentanil

Drug

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)

Primary outcomes

  1. Pressure-Flow Variables measured by combined manometry and impedance system ( ManoScan 360) during pharyngeal swallowing

    Time frame: up to 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection)

Secondary outcomes

  1. Subjective swallowing difficulties measured by 4-point scale

    Time frame: Variables are measured before (baseline) and 15 min and 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection)

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 16, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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