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Trial registered on ANZCTR


Registration number
ACTRN12610000930088
Ethics application status
Approved
Date submitted
30/10/2010
Date registered
2/11/2010
Date last updated
2/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Are the combined use of the target-controlled infusion of remifentanil with desflurane during the maintenance phase of general anesthesia lowering the end-tidal concentration of desflurane?
Scientific title
In patients undergoing surgeries pertaining to the muscular skeletal system, are the combined use of the target-controlled infusion of remifentanil with desflurane during the maintenance phase of general anesthesia lowering the end-tidal concentration of desflurane compared with desflurane only group?
Secondary ID [1] 252989 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
end-tidal concentration of desflurane in patients undergoing surgeries pertaining skeletal muscular system 258526 0
Condition category
Condition code
Anaesthesiology 258685 258685 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
arm 1: maintenance of anesthesia was done with desflurane and effect target controlled concentration 1ng/ml of intravenous remifentanil during the surgery.
arm 2: maintenance of anesthesia was done with desflurane and effect target controlled concentration 2ng/ml of intravenous remifentanil during the surgery

Effect target concentration of remifentanil was achieved with TCI (Target controlled infusion, MODULE DPS ORCHESTRA IS3, Fesenius Vial, France).
Intervention code [1] 257510 0
Treatment: Drugs
Comparator / control treatment
Control group: maintenance of anesthesia was done with desflurane only
Control group
Active

Outcomes
Primary outcome [1] 259545 0
end tidal concentration of desflurane was measured using an anesthetic gas monitoring system(S/5 TM compact anesthesia monitor; Datex-Ohmeda, Tewksbury, MA, USA)
Timepoint [1] 259545 0
5 minute interval from after the 10 minute period of surgical incision to before the 10 minute period of operation end
Secondary outcome [1] 266161 0
mean arterial pressure was measured using anesthetic monitoring system(S/5 TM; Datex-Ohmeda, Tewksbury, MA, USA)
Timepoint [1] 266161 0
5 minute interval from after the 10 minute period of surgical incision to before the 10 minute period of operation end
Secondary outcome [2] 266162 0
heart rate was measured using anesthetic monitoring system(S/5 TM; Datex-Ohmeda, Tewksbury, MA, USA)
Timepoint [2] 266162 0
5 minute interval from after the 10 minute period of surgical incision to before the 10 minute period of operation end
Secondary outcome [3] 266163 0
Existence of awareness during surgery was asked by an investigator.
Timepoint [3] 266163 0
the day after surgery

Eligibility
Key inclusion criteria
the patients undergoing surgeries pertaing muscular skeletal system, without the change of body positioning and expected to have a blood loss rate lower than 200ml
Minimum age
20 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
body weight lower than 45 kg or greater than 100 kg, history of severe underlying cardiovascular, pulmonary, renal or hepatic disease.

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)
The details of the series are kept in a set of sealed envelopes, each bearing only the case number on the outside. After admitting into the operating room and just before the induction of anaesthesia, the numbered envelope was opened and the card inside determined which group the patient would be affiliated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization into one of the four groups was based on Excel random-number generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 3009 0
Korea, Republic Of
State/province [1] 3009 0

Funding & Sponsors
Funding source category [1] 257962 0
Hospital
Name [1] 257962 0
Samsung Changwon Hospital
Country [1] 257962 0
Korea, Republic Of
Primary sponsor type
Hospital
Name
Samsung Changwon Hospital
Address
50, Hapsung-Dong, Masanheiwon-Ku, Changwon-Si, Kyungsangnam-Do 630-522
Country
Korea, Republic Of
Secondary sponsor category [1] 257162 0
Hospital
Name [1] 257162 0
Chung-Ang University Hospital
Address [1] 257162 0
224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755
Country [1] 257162 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259972 0
Institutional Board of Samsung Changwon Hospital
Ethics committee address [1] 259972 0
50, Hapsung-Dong, Masanheiwon-Ku, Changwon-Si, Kyungsangnam-Do 630-522
Ethics committee country [1] 259972 0
Korea, Republic Of
Date submitted for ethics approval [1] 259972 0
01/02/2009
Approval date [1] 259972 0
25/02/2009
Ethics approval number [1] 259972 0

Summary
Brief summary
Desflurane is a widely used inhalational anesthetic. It allows for rapid anesthesia induction, rapid recovery of consciousness, and for the recovery of the general motor function. Its shortcomings are that it causes airway irritation, and increases cerebral blood flow (CBF), and in intracranial pressure (ICP). Furthermore, when a high concentration is administered, it stimulates the sympathetic nervous system.
Remifentanil is a synthetic opioid that is a specific µ-receptor agonist.
When used together with desflurane, remifentanil is considered to be able to make up for the limitations of desflurane and reduce MAC of the anesthetic vapor when maintaining anesthesia.
The goals of this study were to determine the effects of a target-controlled concentration of remifentanil combined with desflurane for decreasing end-tidal concentration of desflurane.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31850 0
Address 31850 0
Country 31850 0
Phone 31850 0
Fax 31850 0
Email 31850 0
Contact person for public queries
Name 15097 0
Myoung Keun Shin
Address 15097 0
Department of Anesthesiology, Samsung Changwon Hospital, 50, Hapsung-Dong, Masanheiwon-Ku, Changwon-Si, Kyungsangnam-Do 630-522
Country 15097 0
Korea, Republic Of
Phone 15097 0
+82-55-290-6072, 6078
Fax 15097 0
Email 15097 0
[email protected]
Contact person for scientific queries
Name 6025 0
Hyun Kang
Address 6025 0
Department of Anaesthesiology and Pain Medicine Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Country 6025 0
Korea, Republic Of
Phone 6025 0
+82-2-6299-2571, 2579, 2586
Fax 6025 0
Email 6025 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
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