Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000013066
Ethics application status
Approved
Date submitted
5/01/2010
Date registered
7/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effect of Changing from Isoflurane to Desflurane during the Latter Part of Anaesthesia on the Recovery Profile
Scientific title
The Effect of Changing from Isoflurane to Desflurane during the Latter Part of Anaesthesia on the Recovery Profile in patients undergoing laparotomy: double blinded randomized clincal trial
Secondary ID [1] 1235 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recovery from anaesthesia for laparatomy. 256461 0
Condition category
Condition code
Anaesthesiology 256632 256632 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
inhaled anaesthesia was maintained with 1.2-2.4 vol% of isoflurane depending on the vital sign to the point when the operation was predicted to end in an hour; subsequently, isoflurane was replaced with 1 minimum alveolar concentration (MAC) of inhaled desflurane (1 MAC of desflurane = 6 vol%) in 1.5 L/min oxygen (O2) and 1.5 L/min nitrous oxide (N2O)
Intervention code [1] 255751 0
Treatment: Drugs
Comparator / control treatment
1. inhaled anaesthesia was maintained with 1.2-2.4 vol% of isoflurane depending on the vital sign to the point when the operation was predicted to end in an hour; subsequently, isoflurane was maintained with 1 MAC of inhaled isoflurane (1MAC of isoflurane = 1.2 vol%) in 1.5 L/min O2 and 1.5 L/min N2O
2. . inhaled anaesthesia was maintained with 6-12 vol% of desflurane depending on the vital sign to the point when the operation was predicted to end in an hour; subsequently, desflurane was maintained with 1 MAC of inhaled desflurane (1 MAC of desflurane = 6 vol%) in 1.5 L/min O2 and 1.5 L/min N2O
Control group
Active

Outcomes
Primary outcome [1] 257523 0
The time to follow the verbal command to open the eyes
Timepoint [1] 257523 0
assessed at 30-s intervals after discontinuation of the inhalation anaesthetic
Secondary outcome [1] 262746 0
The response time to painful pinching
Timepoint [1] 262746 0
assessed at 30-s intervals after discontinuation of the inhalation anaesthetic
Secondary outcome [2] 262747 0
Time to regain orientation to age
Timepoint [2] 262747 0
assessed at 30-s intervals after discontinuation of the inhalation anaesthetic
Secondary outcome [3] 262748 0
Time to regain orientation to name
Timepoint [3] 262748 0
assessed at 30-s intervals after discontinuation of the inhalation anaesthetic

Eligibility
Key inclusion criteria
patients undergoing laparotomy expected to lasting 3 or more hours under general anaesthesia
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with clinically significant pulmonary, cardiovascular, hepatic, renal, hematologic, neurologic, or metabolic diseases and those who were chronic users of drugs that are known to affect anaesthetic requirements

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)
sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
12/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
103
Accrual to date
Final
Recruitment outside Australia
Country [1] 2381 0
Korea, Republic Of
State/province [1] 2381 0

Funding & Sponsors
Funding source category [1] 256233 0
University
Name [1] 256233 0
Chung-Ang University
Country [1] 256233 0
Korea, Republic Of
Primary sponsor type
University
Name
Chung-Ang University
Address
Chung-Ang University College of Medicine
221 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Country
Korea, Republic Of
Secondary sponsor category [1] 251566 0
Hospital
Name [1] 251566 0
Chung-Ang University Hospital
Address [1] 251566 0
Chung-Ang University College of Medicine
224-1 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Country [1] 251566 0
Korea, Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258327 0
Institutional Review Board at the Chung-Ang University School of Medicine
Ethics committee address [1] 258327 0
Chung-Ang University College of Medicine
224-1 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Ethics committee country [1] 258327 0
Korea, Republic Of
Date submitted for ethics approval [1] 258327 0
Approval date [1] 258327 0
11/09/2008
Ethics approval number [1] 258327 0
c2008013(116)

Summary
Brief summary
Compared to other currently available inhalational anaesthetics, desflurane is less soluble. Consequently, its rapid elimination from the brain is expected to result in an improved postoperative recovery profile. However, desflurane is more expensive to administer than other inhalational anaesthetics.
Isoflurane is a commonly used inhaled volatile anaesthetic because it is relatively inexpensive despite its high solubility. To combine the advantages of rapid emergence from desflurane anaesthesia with the lower cost of a more soluble inhalation anaesthetic, we substitute desflurane with isoflurane during the latter part of anaesthesia and compare the emergence and recovery characteristic with pure desflurane and pure isoflurane anesthesia.
We hypothesize the substitution from isoflurane to desflurane during the latter part of anesthesia improve recovery and emergence characteristics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30654 0
Address 30654 0
Country 30654 0
Phone 30654 0
Fax 30654 0
Email 30654 0
Contact person for public queries
Name 13901 0
Hyun Kang
Address 13901 0
Department of Anaesthesiology and Pain Medicine
Chung-Ang University College of Medicine
224-1 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Country 13901 0
Korea, Republic Of
Phone 13901 0
+82-2-6299-2571
Fax 13901 0
Email 13901 0
[email protected]
Contact person for scientific queries
Name 4829 0
Hyun Kang
Address 4829 0
Department of Anaesthesiology and Pain Medicine
Chung-Ang University College of Medicine
224-1 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Country 4829 0
Korea, Republic Of
Phone 4829 0
+82-2-6299-2571
Fax 4829 0
Email 4829 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.