Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001075875
Ethics application status
Approved
Date submitted
10/09/2012
Date registered
8/10/2012
Date last updated
8/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of clonidine on heart rate variability analysis in patients undergoing key-hole surgery to remove gallbladder
Scientific title
A prospective study to validate the effect of clonidine on Analgesia Nociceptive Index in patients undergoing laparoscopic cholecystectomy
Secondary ID [1] 281199 0
NIL
Universal Trial Number (UTN)
U1111-1134-4651
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intraoperative pain relief during cholecystectomy 287380 0
Condition category
Condition code
Anaesthesiology 287712 287712 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive a standardised protocol for induction of anaesthesia with fentanyl, propofol and rocuronium. . A standard IV paracetamol 1g and IV Parecoxib 40mg (if no contraindication) are also given. Analgesia Nociception Index (ANI) will be recorded at every 5 minute intervals. IV Clonidine 1mcg/kg will be given 5 mins following pneumoperitoneum. Any further dose of fentanyl given will be recorded
Intervention code [1] 285666 0
Treatment: Drugs
Comparator / control treatment
the patient acts as his own control whereby the ANI of pre-clonidine is compared against post clonidine
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287964 0
Effect of clonidine on ANI, whether it increases, decreases or no change; a mean 10 point change being accepted as significant
Timepoint [1] 287964 0
ANI, BP and HR recorded pre surgical incison, at surgical incison, pre carbon dioxide insufflation into peritoneum, 5 minutes after CO2 insufflation when clonidine is given, and every 5 minutes thereafter for 30 minutes

total about 60 minutes
Secondary outcome [1] 299143 0
NIL
Timepoint [1] 299143 0
NIL

Eligibility
Key inclusion criteria
Laparoscopic cholecystectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to consent
below 18 years old
Established arrhythmias
Allergy/sensitivity to clonidine
diabetes mellitus and autonomic neuropathy
sepsis/ emodynamic instability
chronic pain

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)
Patients who fulfill the inclusion and exclusion criteria will be identified from the surgical operating list (emergency and elective). Informed written consent will be obtained by the research team or the anaesthetist/anaestetic registrar. There is no randomization involved.
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 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285982 0
Hospital
Name [1] 285982 0
Fremantle Hospital
Country [1] 285982 0
Australia
Primary sponsor type
Hospital
Name
fremantle Hospital
Address
Alma Street
Fremantle
WA 6160
Country
Australia
Secondary sponsor category [1] 284801 0
None
Name [1] 284801 0
Address [1] 284801 0
Country [1] 284801 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288017 0
Human Research Ethics Committee, Fremantle Hospital
Ethics committee address [1] 288017 0
Ethics committee country [1] 288017 0
Australia
Date submitted for ethics approval [1] 288017 0
07/08/2012
Approval date [1] 288017 0
Ethics approval number [1] 288017 0
1/12/0244

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34694 0
Address 34694 0
Country 34694 0
Phone 34694 0
Fax 34694 0
Email 34694 0
Contact person for public queries
Name 17941 0
Anisa Abu Baker
Address 17941 0
Department of Anaesthetics
Fremantle Hospital and Health Service
Alma Street
Fremantle
Western Australia 6160
Country 17941 0
Australia
Phone 17941 0
+61894312551
Fax 17941 0
+61894312171
Email 17941 0
anisa.aisha@gmail.com
Contact person for scientific queries
Name 8869 0
Anisa Abu Baker
Address 8869 0
Department of Anaesthetics
Fremantle Hospital and Health Service
Alma Street
Fremantle
Western Australia 6160
Country 8869 0
Australia
Phone 8869 0
+61894312551
Fax 8869 0
+61894312171
Email 8869 0
anisa.aisha@gmail.com

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.