Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000259044
Ethics application status
Approved
Date submitted
29/03/2010
Date registered
30/03/2010
Date last updated
25/11/2021
Date data sharing statement initially provided
25/11/2021
Date results information initially provided
25/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of sevoflurane on the corrected interval between the Q wave and T wave of the electrocardiogram (QTc) in patients with diabetes mellitus.
Scientific title
The effect of sevoflurane on the corrected QT interval (QTc), QTc dispersion, the interval between peak to end of T wave (Tp-e) and Tp-e/QTc ratio in diabetic and non diabetic women undergoing elective non-laparoscopic surgery requiring general anaesthesia with endotracheal intubation
Secondary ID [1] 1555 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus 257044 0
Condition category
Condition code
Anaesthesiology 257205 257205 0 0
Anaesthetics
Metabolic and Endocrine 257206 257206 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
General anaesthesia with sevoflurane at 1.0 minimum alveolar concentration (MAC) administered through an endotracheal tube in to the patients lungs during the surgical period which is roughly two hours.
Intervention code [1] 256221 0
Early detection / Screening
Intervention code [2] 256226 0
Other interventions
Comparator / control treatment
Diabetic patients would be compared with a control group of non-diabetic patients. Both the groups would receive exactly the same treatment.
Control group
Active

Outcomes
Primary outcome [1] 258099 0
Difference in Tp-e interval between- the groups and within the groups
This outcome measure and all other outcome measures was assessed from the same recorded electrocardiogram strips.
Timepoint [1] 258099 0
After intubation , and at 5 min , 15 min , 30 min , 60 min after general anaesthesia.
Primary outcome [2] 301635 0
Difference in Tp-e/QTc ratio between- the groups and within the groups
This outcome measure and all other outcome measures was assessed from the same recorded electrocardiogram strips.
Timepoint [2] 301635 0
After intubation, 5min, 15 min, 30 min and 60 minutes into the anaesthetic, Same as all the other outcomes
Secondary outcome [1] 263701 0
Difference between the QTc interval between- the groups and within the groups
This outcome measure and all other outcome measures was assessed from the same recorded electrocardiogram strips.
Timepoint [1] 263701 0
after intubation , and at 5 min , 15 min , 30 min , 60 min after general anaesthesia
Secondary outcome [2] 333360 0
Difference between the QTc Dispersion between- the groups and within the groups
This outcome measure and all other outcome measures was assessed from the same recorded electrocardiogram strips.
Timepoint [2] 333360 0
After intubation, 5 min, 15 min, 30 min and 60 min into the study period

Eligibility
Key inclusion criteria
Women aged > 40 yr ASA I – III (American society of Anesthesiologists physical status) scheduled for elective non-laparoscopic surgical procedures lasting more than 60 min requiring general anaesthesia with endotracheal intubation would be recruited in this study. Medically managed (both oral hypoglycaemic agents and insulin) diabetic patients with the duration of the disease for atleast two years or those who have atleast one HbA1c (glycosylated haemoglobin) level more than 7% recorded prior to the presentation would be compared with a control group of non diabetic patients.
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a preoperative QTc interval greater than 440ms, having conduction defects and arrhythmias, taking medications affecting the QTc interval , suffering from ischemic heart disease as defined by previous history of angina, myocardial infarction or ischaemic cardiomyopathy, patients with congenital or acquired cardiac defects, preexisting electrolyte imbalances and thyroid and renal dysfunction as defined by the estimated glomerular filtration rate (eGFR) < 60 ml/min/ 1.73m 2 would be excluded. Diabetic patients on diet control and patients with known or suspected family history of malignant hyperthermia would also be excluded

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



Intervention assignment
Other
Other design features
Patients will be enrolled at the preadmission clinic as they present to the surgical procedures if they fulfill the inclusion criteria and if they are willing to participate. The assignment is based on which group they belong to. The investigator interpreting the outcomes would be blinded to the group assignment
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
30/09/2010
Date of last participant enrolment
Anticipated
20/12/2014
Actual
25/11/2014
Date of last data collection
Anticipated
20/12/2014
Actual
25/11/2014
Sample size
Target
40
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 6521 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 14094 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 256722 0
Hospital
Name [1] 256722 0
The Queen Elizabeth Hospital
Country [1] 256722 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital
Address
The Queen Elizabeth Hospital
28 Woodville Road
Woodville, SA 5011
Country
Australia
Secondary sponsor category [1] 256006 0
None
Name [1] 256006 0
Address [1] 256006 0
Country [1] 256006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258731 0
The Queen Elizabeth Hospital Ethics Committee
Ethics committee address [1] 258731 0
28 Woodville Road
Woodville
South Australia
5011
Ethics committee country [1] 258731 0
Australia
Date submitted for ethics approval [1] 258731 0
07/04/2010
Approval date [1] 258731 0
23/01/2014
Ethics approval number [1] 258731 0

Summary
Brief summary
Sevoflurane is one of the widely used anaesthetic vapours for general anaesthesia. This vapour is delivered to the patients lungs through a breathing tube. It is known to alter the electrical activity of the heart. This manifests as a prolonged QTc interval of the electrocardiogram (ECG). One of the potential dangers associated with this phenomenon is the occurrence of a dangerous irregular heart beat. However, it is a very rare condition.

People with diabetes mellitus are more prone to have a prolonged QTc interval due to various reasons. It is not known whether the diabetic patients are at an increased risk of QTc prolongation compared with non diabetics on exposure to sevoflurane anaesthesia.
This study tries to look at the impact of sevoflurane on the QTc interval in patients with diabetes mellitus. The primary outcome parameters of interest are the Tp-e interval and Tp-e / QTc ratio of the ECG, as these measures are sensitive in predicting dangerous arrhythmias. The secondary outcome measures of interest are Qtc and QTcd values of the ECG.
Trial website
Trial related presentations / publications
None, Trying to publish
Public notes

Contacts
Principal investigator
Name 30988 0
Dr Venkatesan Thiruvenkatarajan
Address 30988 0
Department of Anaesthesia, The Quen Elizabeth Hospital, Woodville, SA
Country 30988 0
Australia
Phone 30988 0
0061431819763
Fax 30988 0
Email 30988 0
[email protected]
Contact person for public queries
Name 14235 0
Dr Venkatesan Thiruvenkatarajan
Address 14235 0
Department of Anaesthesia
The Queen Elizabeth Hospital
28 Woodville Road
Woodville
SA 5011
Country 14235 0
Australia
Phone 14235 0
+61 8 82226640
Fax 14235 0
+61 8 82227065
Email 14235 0
[email protected]
Contact person for scientific queries
Name 5163 0
Dr Venkatesan Thiruvenkatarajan
Address 5163 0
Department of Anaesthesia
The Queen Elizabeth Hospital
28 Woodville Road
Woodville
SA 5011
Country 5163 0
Australia
Phone 5163 0
+61 8 82226640
Fax 5163 0
+61 8 82227065
Email 5163 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.