Effect of Dexmedetomidine on Gastric Emptying and Gastrointestinal Transit

NCT ID: NCT01084473

Last Updated: 2010-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-06-30

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.

Conditions

Gastric Emptying; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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).

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

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

The study subjects will be given a saline infusion.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9 % NaCl will be infused.

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Placebo

0.9 % NaCl will be infused.

Intervention Type: DRUG

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)].

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

University of Turku

OTHER

Sponsor Role: lead

Responsible Party

Turku University Hospital and Turku University

Principal Investigators

Timo Iirola, MD

Role: PRINCIPAL_INVESTIGATOR

Turku University, Turku University Hospital

Locations

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

Turku, , Finland

Countries

Finland

Other Identifiers

GADEX

Identifier Type: -

Identifier Source: org_study_id