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

This study has been completed.
Sponsor:
Collaborator:
Helsinki University
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT01084473
First received: March 9, 2010
Last updated: June 3, 2010
Last verified: March 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Dexmedetomidine
Morphine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Narcotics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014