Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
1235
0
nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
recovery from anaesthesia for laparatomy.
256461
0
Query!
Condition category
Condition code
Anaesthesiology
256632
256632
0
0
Query!
Anaesthetics
Query!
Intervention/exposure
Study type
Interventional
Query!
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)
Query!
Intervention code [1]
255751
0
Treatment: Drugs
Query!
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
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
257523
0
The time to follow the verbal command to open the eyes
Query!
Assessment method [1]
257523
0
Query!
Timepoint [1]
257523
0
assessed at 30-s intervals after discontinuation of the inhalation anaesthetic
Query!
Secondary outcome [1]
262746
0
The response time to painful pinching
Query!
Assessment method [1]
262746
0
Query!
Timepoint [1]
262746
0
assessed at 30-s intervals after discontinuation of the inhalation anaesthetic
Query!
Secondary outcome [2]
262747
0
Time to regain orientation to age
Query!
Assessment method [2]
262747
0
Query!
Timepoint [2]
262747
0
assessed at 30-s intervals after discontinuation of the inhalation anaesthetic
Query!
Secondary outcome [3]
262748
0
Time to regain orientation to name
Query!
Assessment method [3]
262748
0
Query!
Timepoint [3]
262748
0
assessed at 30-s intervals after discontinuation of the inhalation anaesthetic
Query!
Eligibility
Key inclusion criteria
patients undergoing laparotomy expected to lasting 3 or more hours under general anaesthesia
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelope
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
excel random number generation
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
12/09/2008
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
103
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
2381
0
Korea, Republic Of
Query!
State/province [1]
2381
0
Query!
Funding & Sponsors
Funding source category [1]
256233
0
University
Query!
Name [1]
256233
0
Chung-Ang University
Query!
Address [1]
256233
0
Chung-Ang University College of Medicine
221 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Query!
Country [1]
256233
0
Korea, Republic Of
Query!
Primary sponsor type
University
Query!
Name
Chung-Ang University
Query!
Address
Chung-Ang University College of Medicine
221 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Query!
Country
Korea, Republic Of
Query!
Secondary sponsor category [1]
251566
0
Hospital
Query!
Name [1]
251566
0
Chung-Ang University Hospital
Query!
Address [1]
251566
0
Chung-Ang University College of Medicine
224-1 Heukseok-dong, Dongjak-gu
Seoul, 156-755, Korea
Query!
Country [1]
251566
0
Korea, Republic Of
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
258327
0
Institutional Review Board at the Chung-Ang University School of Medicine
Query!
Ethics committee address [1]
258327
0
Chung-Ang University College of Medicine 224-1 Heukseok-dong, Dongjak-gu Seoul, 156-755, Korea
Query!
Ethics committee country [1]
258327
0
Korea, Republic Of
Query!
Date submitted for ethics approval [1]
258327
0
Query!
Approval date [1]
258327
0
11/09/2008
Query!
Ethics approval number [1]
258327
0
c2008013(116)
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
30654
0
Query!
Address
30654
0
Query!
Country
30654
0
Query!
Phone
30654
0
Query!
Fax
30654
0
Query!
Email
30654
0
Query!
Contact person for public queries
Name
13901
0
Hyun Kang
Query!
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
Query!
Country
13901
0
Korea, Republic Of
Query!
Phone
13901
0
+82-2-6299-2571
Query!
Fax
13901
0
Query!
Email
13901
0
[email protected]
Query!
Contact person for scientific queries
Name
4829
0
Hyun Kang
Query!
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
Query!
Country
4829
0
Korea, Republic Of
Query!
Phone
4829
0
+82-2-6299-2571
Query!
Fax
4829
0
Query!
Email
4829
0
[email protected]
Query!
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.
Download to PDF