Effect of Dexmedetomidine on Gastric Emptying and Gastrointestinal Transit

Healthy Clinical Trial

— GADEX  

Official title:

Effect of Dexmedetomidine Infusion on Gastric Emptying and Gastrointestinal Transit in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084473
• Other study ID #: GADEX
• Status: Completed
• Phase: Phase 1
• First received: March 9, 2010
• Last updated: June 3, 2010
• Start date: March 2010
• Est. completion date: June 2010

Study information

• Verified date: March 2010
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)].

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Gastric Emptying
• Healthy

Intervention

Drug:
• Dexmedetomidine
The study subjects will be given a normal loading dose (1 µg/kg in 20 minutes) of dexmedetomidine (dexmedetomidine hydrochloride 100 µg/ml, Precedex® Abbott Laboratories North Chicago, IL 60064, USA) followed by continuous infusion of 0.7 µg/kg/h for 190 min. The administration of the loading dose will be started at t = -30 min (30 min prior to the administration of paracetamol and lactulose).
• Morphine
The study subjects will be given 0.10 mg/kg morphine hydrochloride (morphine hydrochloride 2 mg/ml, Morphin® Nycomed Austria GmbH, St. Peter Strasse 25, A-4021, Linz, Austria) in 20 minutes followed by a placebo infusion for 190 min. The administration of the morphine infusion will be started at t = -30 min (30 min prior to the administration of paracetamol and lactulose).
• Placebo
0.9 % NaCl will be infused.

Locations

Country	Name	City	State
Finland	Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
University of Turku	Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of dexmedetomidine on gastric emptying and oro-caecal transit time	5 ml venous blood samples will be collected immediately prior to administration of paracetamol (baseline) and thereafter at 10, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210 and 240 min into EDTA tubes for determination of paracetamol plasma concentrations. End-expiratory breath samples will be obtained immediately prior to administration of lactulose (baseline) and thereafter at 15, 30, 45, 60, 75, 90, 105 and 120 min.	10, 15, 20, 30, 40, 45, 50, 60, 70, 75, 80, 90, 105, 120, 135, 150, 165, 180, 210 and 240 min	No