Clinical trial NCT01084473: Effect of Dexmedetomidine on Gastric Emptying and Gastrointestinal Transit
Official title: Effect of Dexmedetomidine Infusion on Gastric Emptying and Gastrointestinal Transit in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastric Emptying
Healthy
Keywords: Dexmedetomidine
gastric emptying
oro-cecal transit time
Sedation in intensive care
Gastrointestinal effects of sedation
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2010-03-10
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of the study is to determine the effect of dexmedetomidine infusion on gastric emptying and oro-caecal transit time in healthy volunteers, judged by measuring plasma paracetamol concentrations after paracetamol ingestion and pulmonary hydrogen measurement technique after lactulose ingestion. The effects of dexmedetomidine will be compared to the effects of morphine and placebo.


Eligibility criteria: Inclusion Criteria:

* Normal cognitive function and fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel
* Age ≥ 18 years.
* Male gender.
* Weight ≥ 60 kg.
* Written informed consent from the subject.

Exclusion Criteria:

* Previous history of intolerance to the study drugs or related compounds and additives.
* Concomitant drug therapy of any kind except ibuprofen in the 14 days prior to the study days.
* Existing or recent significant disease.
* History of haematological, endocrine, metabolic or gastrointestinal disease.
* History of asthma or any kind of drug allergy.
* Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
* A positive test result for urine toxicology.
* A "yes" answer to any of the questions in a modified Finnish version of the Abuse Questions
* Donation of blood within six weeks prior to and during the study.
* Special diet or lifestyle factors which would compromise the conditions of the study or the interpretation of the results.
* BMI \> 30 kg / m2.
* Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
* Smoking during one month before the start of the study or during the study period.
* Clinically significant abnormal findings in physical examination, ECG or laboratory screening \[routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)\].

Primary outcomes:
measure: The effect of dexmedetomidine on gastric emptying and oro-caecal transit time
timeFrame: 10, 15, 20, 30, 40, 45, 50, 60, 70, 75, 80, 90, 105, 120, 135, 150, 165, 180, 210 and 240 min
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital
Study officials:
affiliation: Turku University, Turku University Hospital
name: Timo Iirola, MD
role: PRINCIPAL_INVESTIGATOR
References: