Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000522516
Ethics application status
Approved
Date submitted
1/06/2006
Date registered
18/12/2006
Date last updated
18/12/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing for interactions between anaesthetic drugs
Scientific title
The use of response modelling to define the interaction between sevoflurane and remifentanil as measured by Observer Assessment Sleep and Sedation (OASS) score and bispectral index during general anaesthesia.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients who are undergoing any type of surgery that require general anaesthetic, intubation and the surgery duration is more than one hour. 1497 0
Condition category
Condition code
Anaesthesiology 1594 1594 0 0
Anaesthetics
Surgery 1595 1595 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
That response surface methodology (a technique that models the pharmacodynamic effect of two and three drug combinations) can define the interaction between sevoflurane and remifentanil for the duration of a general anaesthetic (approx 2 hrs). Remifentanil intravenously dose range 0.05 & 0.25%mcg/kg/min, and will be incremented. Sevoflurane dose range will be 0.25-1.25% mcg/kg/min.
One drug will be randomly assigned as the start drug and ramped up to a preset randomly selected dose within the dose range (sevoflurane 0.25, 0.5, 0.75, 1.0 or 1.25%, remifentanil 0.05, 0.1, 0.15, 0.2 or 0.25%mcg/kg/min) then second drug will be introduced and ramped up until OASS score of 5 is attained. Doses will be incremented once 5 plasma half times have elapsed to allow equilibration at the effect site. This will approximately 5 mins for each increment. Increments will be ceased when patient is OASS 5 (unconscious and able to tolerate laryngoscopy) at which stage the patient will be intubated and preparations for surgery to be continued.
Intervention code [1] 1082 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2200 0
Bispectral Index (BIS)
Timepoint [1] 2200 0
Measured for the duration of surgery estimated 1 to 4 hours at 1 minute intervals.
Primary outcome [2] 2201 0
Observer Assessment Sleep & Sedation (OASS)
Timepoint [2] 2201 0
Measured 5 min after every change in drug dosage.
Secondary outcome [1] 3833 0
Physiological - Blood Pressure and Pulse.
Timepoint [1] 3833 0
5 min intervals during the general anaesthetic estimated 1 to 4 hours.

Eligibility
Key inclusion criteria
1) American Society Anaesthesiology Grade (ASA) grade 1-3 (healthy or with mild or moderate but stable disease). 2) Surgery usually associated with minimal blood loss and expected to last at least 1.5hrs.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Contraindication to using reminfentanil or sevoflurane - including allergy and malignant hyperpyrexia2) inability to converse fluently in English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
nil
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 324 0
New Zealand
State/province [1] 324 0

Funding & Sponsors
Funding source category [1] 1739 0
Hospital
Name [1] 1739 0
Patient Vital Signs Monitoring Group Committee based at Auckland City Hosptial
Country [1] 1739 0
New Zealand
Primary sponsor type
Individual
Name
Dr Doug Campbell
Address
Country
Secondary sponsor category [1] 1534 0
Individual
Name [1] 1534 0
Dr Timothy Short
Address [1] 1534 0
Country [1] 1534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3217 0
Auckland City Hospital-Northern X Regional Ethics Committee
Ethics committee address [1] 3217 0
Ethics committee country [1] 3217 0
New Zealand
Date submitted for ethics approval [1] 3217 0
Approval date [1] 3217 0
13/05/2006
Ethics approval number [1] 3217 0
NTX/06/04/041

Summary
Brief summary
General anaesthesia is a complex process requiring many drugs being given to a patient and monitoring their effect on organs like the heart, lungs and brain. These drugs can have similar actions but the combined effects can be complicated and difficult to predict because of large variations of drug dosing and differences in patient responses. This study aims to establish the interaction between sevofularane and remifentanil across a wide variety of doses for different anaesthesia and endpoints
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36183 0
Address 36183 0
Country 36183 0
Phone 36183 0
Fax 36183 0
Email 36183 0
Contact person for public queries
Name 10271 0
Dr Timothy Short
Address 10271 0
Auckland City Hospital
Department of Anaesthesia
Level 8, Support Building
Park Road, Grafton
Auckland
Country 10271 0
New Zealand
Phone 10271 0
0064 274 542 464
Fax 10271 0
0064 9 307 2814
Email 10271 0
[email protected]
Contact person for scientific queries
Name 1199 0
Dr Doug Campbell
Address 1199 0
Auckland City Hospital
Department of Anaesthesia
Level 8, Support Building
Park Road, Grafton
Auckland
Country 1199 0
New Zealand
Phone 1199 0
0064 2 503 010
Fax 1199 0
0064 9 307 2814
Email 1199 0
[email protected]

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.