Dexmedetomidine and Swallowing Function

NCT ID: NCT03390972

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2018-04-11

Brief Summary

The purpose of the study is to evaluate the impact of dexmedetomidine on swallowing function in healthy volunteers using combined pressure and impedance recordings. Furthermore, two different concentrations of dexmedetomidine will be studied to find out whether any posible impact of dexmedetomidine on swallowing function is dose-dependent.

Detailed Description

Monitored anesthesia care (MAC) is commonly applied in modern perioperative care and means that minor surgical procedures are accomplished in awake patients using local anesthesia and light sedation. MAC has many advantages compared to general anesthesia; the recovery time after anesthesia is shorter and risk for postoperative nausea is lower to mention some. However, the patient is spontaneously breathing and the airway is not protected by an endotracheal tube which potentially increases risk of pulmonary aspiration. Pulmonary aspiration, that is inhalation of stomach and/or pharyngeal contents into the lungs, is a severe anesthesia-related complication and can in worst case lead to pneumonia and even death. Intact swallowing function is crucial in avoiding aspiration and how sedatives and analgesic agents used during MAC influence swallowing function is not fully understood.

Pharyngeal function during bolus swallowing is measured by combined high resolution impedance manometry (HRIM). The HRIM catheter is inserted through the nose in such a way that sensors straddle the entire pharynx and esophagus with the distal catheter tip in the stomach. Dynamic pressure changes and flow can be detected during swallowing and data registered by HRIM are analysed using purpose-designed software, AIM analysis (automated impedance manometry analysis). AIM analysis derives pressure flow variables which describe different physiological events like bolus timing and bolus distension in the pharynx and the esophagus during swallowing. A Swallow Risk Index value, quantifying risk of deglutitive aspiration, can also be defined.

The aim of the study is to evaluate impact of dexmedetomidine on swallowing function in healthy volunteers.Dexmedetomidine is a selective alfa-agonist frequently used during MAC. Furthermore, two different concentrations of dexmedetomidine will be studied to find out whether any posible impact of dexmedetomidine on swallowing function is dose-dependent. Moreover, subjective swallowing difficulties will be assessed.

20 healthy volunteers will be studied on two different occasions approximately one week apart. In a randomized order volunteers will receive intravenous infusion of dexmedetomidine in two subsequent concentrations and placebo (normal saline) infusion in corresponding doses on the other occasion. Blood samples are obtained for plasma concentration determination of the study drug and sedation levels are assessed during study drug exposure.

Conditions

Deglutition

Study Design

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

Study Groups

Dexmedetomidine

Volunteers are given an intravenous infusion with dexmedetomidine, with an effect-site target concentration of 0.6 ng/ml via a target-controlled infusion (TCI) pump. After a series of swallowing tests the effect-site target concentration is raised to 1.2 ng/ml and the swallowing series is repeated.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

Dexmedetomidine TCI 0.6 ng/ml and 1.2 ng/ml

Placebo

Volunteers are given an intravenous infusion with saline 0,9% with target controlled infusion pump in corresponding doses as in the dexmedetomidine arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo (NaCl 0.9%) TCI infusion

Interventions

Placebo

Placebo (NaCl 0.9%) TCI infusion

Intervention Type: DRUG

Dexmedetomidine

Dexmedetomidine TCI 0.6 ng/ml and 1.2 ng/ml

Intervention Type: DRUG

Other Intervention Names

Sodium Chloride 0.9%; Dexdor

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 - ≤ 40 year old healthy volunteers from both sexes.

2. Have signed and dated Informed Consent.

3. Willing and able to comply with the protocol for the duration of the trial.

Exclusion Criteria

1. Anamnesis of pharyngoesophageal dysfunction.

2. Known or history of gastrointestinal, severe cardiac, pulmonary or neurological disease

3. Ongoing medication that may affect upper gastrointestinal tract, larynx or lower airway.

4. Allergies to or history of reaction to remifentanil, fentanyl analogues or dexmedetomidine.

5. Known heart rhythm disorder.

6. Tendency to faint.

7. Pregnancy or breast feeding

8. BMI > 30

9. Smoking

10. Participation in a medicinal clinical trial during the last year where an opioid has been used or have during the last 30 days participated in any other medicinal clinical trial or in a trial where follow-up is 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

Responsibility Role: SPONSOR

Principal Investigators

Johanan Savilampi, Phd

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology and Intensive Care, Örebro University Hospital

Central Contacts

Johanna Savilampi, Phd

Role: CONTACT

johanna.savilampi@regionorebrolan.se

+46 019 6020266

Per Cajander, MD

Role: CONTACT

per.cajander@regionorebrolan.se

+46 019 6020353

Other Identifiers

JS007

Identifier Type: -

Identifier Source: org_study_id