Effect of Dexmedetomidine on Gastric Emptying and Gastrointestinal Transit - Full Text View

Purpose

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.

Condition	Intervention	Phase
Gastric Emptying Healthy	Drug: Dexmedetomidine Drug: Morphine Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject)
Official Title:	Effect of Dexmedetomidine Infusion on Gastric Emptying and Gastrointestinal Transit in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Morphine hydrochloride Morphine sulfate Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Turku:

Primary Outcome Measures:

The effect of dexmedetomidine on gastric emptying and oro-caecal transit time [ Time Frame: 10, 15, 20, 30, 40, 45, 50, 60, 70, 75, 80, 90, 105, 120, 135, 150, 165, 180, 210 and 240 min ] [ Designated as safety issue: No ]
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.

Enrollment:	12
Study Start Date:	March 2010
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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).	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).
Active Comparator: 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).	Drug: 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 Comparator: Placebo The study subjects will be given a saline infusion.	Drug: Placebo 0.9 % NaCl will be infused.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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)].

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084473

Locations

Finland
Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital
Turku, Finland, 20520

Sponsors and Collaborators

University of Turku

Helsinki University

Investigators

Principal Investigator:

Timo Iirola, MD

Turku University, Turku University Hospital

More Information

No publications provided

Responsible Party:	Timo Iirola, Turku University Hospital and Turku University
ClinicalTrials.gov Identifier:	NCT01084473 History of Changes
Other Study ID Numbers:	GADEX
Study First Received:	March 9, 2010
Last Updated:	June 3, 2010
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by University of Turku:

Dexmedetomidine
gastric emptying
oro-cecal transit time
Sedation in intensive care
Gastrointestinal effects of sedation

Additional relevant MeSH terms:

Morphine
Dexmedetomidine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Central Nervous System Depressants
Narcotics
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013

Effect of Dexmedetomidine on Gastric Emptying and Gastrointestinal Transit (GADEX)