Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000794909
Ethics application status
Approved
Date submitted
28/07/2011
Date registered
28/07/2011
Date last updated
28/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of intravenous sedation on the lower oesophageal sphincter: A comparison between dexmedetomidine and remifentanil in healthy adult volunteers.
Scientific title
The effect of intravenous sedation on the lower oesophageal sphincter: A comparison between dexmedetomidine and remifentanil in healthy adult volunteers.
Secondary ID [1] 262727 0
Nil
Universal Trial Number (UTN)
U1111-1123-2271
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aspiration Risk during sedation 270436 0
Reflux and sedation 270437 0
Condition category
Condition code
Anaesthesiology 270580 270580 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sedation of Healthy volunteers. Cross over study between 2 sedation medications: Remifentanil and Dexmedetomidine.
Remifentanil Sedation: Target-Controlled Infusion: 0.1, 0.2, 0.3 and 0.4 mcg/Kg/min. Duration: 20 minutes at each target concentration.
Period between cross-over: 1 week
Target controlled infusions will be administered consecutively in an ascending pattern (lower to higher concentrations)
Intervention code [1] 267073 0
Treatment: Drugs
Comparator / control treatment
Dexmedetomidine Sedation. Target Controlled Infusions:0.1, 0.2, 0.4, 0.6 and 0.8 ng/ml. Duration: 20 minutes at each target concentration
Target controlled infusions will be administered consecutively in an ascending pattern (lower to higher concentrations)
Control group
Active

Outcomes
Primary outcome [1] 269322 0
Oesophageal motor activity as assessed by oesophageal manometry, using multi-lumen perfused catheters
Timepoint [1] 269322 0
continuous measurement at time of administration of sedating infusion.
Primary outcome [2] 269323 0
oesophageal motility and reflux will be assessed by oesophageal intraluminal electrical impedance, using 4 pairs of ring electrodes.
Timepoint [2] 269323 0
continuous measurement at time of administration of sedating infusion.
Primary outcome [3] 269324 0
Oesophageal pH will be monitored using an antimony pH electrode positioned 5cm above the proximal margin of the LOS
Timepoint [3] 269324 0
continuous measurement at time of administration of sedating infusion.
Secondary outcome [1] 279375 0
Patient reported alertness will be assessed by Visual Analogue Scale (VAS)
Timepoint [1] 279375 0
10 minutes after commencement of each target plasma concentration
Secondary outcome [2] 279376 0
Observer Assessment of Alertness/Sedation Scale (OASS)
Timepoint [2] 279376 0
10 minutes after commencement of each target plasma concentration
Secondary outcome [3] 279377 0
Patient's response to temperature (as a marker of analgesia) will be assessed by a Thermal Sensory Analyser (TSA)
Timepoint [3] 279377 0
15 minutes after commencement of each target plasma concentration
Secondary outcome [4] 279378 0
Pateints' quantitative EEG activity will be assessed by Bispectral index (BIS) measurement
Timepoint [4] 279378 0
continuous measurement at 5-minute intervals during administration of sedating infusion

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(i) Inability to give informed consent
(ii) Pregnancy or breast feeding
(iii) Previous gastrointestinal surgery (apart from appendicectomy)
(iv) medications known to affect gastrointestinal motility (erythromycin, metoclopramide and domperidone)
(v) Clinically diagnosed gastro-oesophageal reflux disease and on acid suppression therapy
(vi) Current use of opiates or any sedatives
(vii) History of cardiac disease
(viii) History of lung disease
(ix) Smoking
(x) Kidney disease
(xi) Liver disease
(xii) diabetes
(xiii) Known allergy to anaesthetic drugs or any reported difficulties during previous anaesthesia
(xiv) BMI > 33

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrollment: Advertising
Allocation: Concealment performed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267545 0
Government body
Name [1] 267545 0
NHMRC
Country [1] 267545 0
Australia
Primary sponsor type
Individual
Name
Dr Islam Elhalawani
Address
The Queen Elizabeth Hospital
Anaesthesia
28 WoodvilleRoad
Woodville West
SA
5011
Country
Australia
Secondary sponsor category [1] 266583 0
None
Name [1] 266583 0
Address [1] 266583 0
Country [1] 266583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269506 0
The Royal Adelaide Hospital Ethics Committee
Ethics committee address [1] 269506 0
The Royal Adelaide Hospital
North Terrace
Adelaide
5000
SA
Ethics committee country [1] 269506 0
Australia
Date submitted for ethics approval [1] 269506 0
21/07/2010
Approval date [1] 269506 0
16/11/2010
Ethics approval number [1] 269506 0
100824

Summary
Brief summary
The primary aim of this study is to assess the effect of sedation on lower oesophageal sphincter (LOS) function and to compare the effects of two types of sedating drugs, Remifentanil and Dexmedetomidine, on LOS function. This is performed to assess the risk of aspiration during sedation both in theatres as well as the intensive care unit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32944 0
Address 32944 0
Country 32944 0
Phone 32944 0
Fax 32944 0
Email 32944 0
Contact person for public queries
Name 16191 0
Dr Islam Elhalawani
Address 16191 0
The Queen Elizabeth Hospital
Anaesthesia Department
28 Woodville Road
Woodville West
SA 5011
Country 16191 0
Australia
Phone 16191 0
+618 8222 6000
Fax 16191 0
Email 16191 0
elhalawani@me.com
Contact person for scientific queries
Name 7119 0
Dr Islam Elhalawani
Address 7119 0
The Queen Elizabeth Hospital
Anaesthesia Department
28 Woodville Road
Woodville West
SA 5011
Country 7119 0
Australia
Phone 7119 0
+618 8222 6000
Fax 7119 0
Email 7119 0
elhalawani@me.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.