Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000581864
Ethics application status
Approved
Date submitted
27/05/2012
Date registered
30/05/2012
Date last updated
30/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative evaluation of isobaric ropivacaine (0.75%) with the adjuvants - clonidine and dexmedetomidine administered intrathecally in adult patients undergoing infra-umbilical surgeries
Scientific title
Comparative evaluation of isobaric ropivacaine (0.75%) with the adjuvants - clonidine and dexmedetomidine administered intrathecally in adult patients undergoing infra-umbilical surgeries
Secondary ID [1] 280560 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intrathecal drugs 286563 0
Condition category
Condition code
Anaesthesiology 286831 286831 0 0
Other anaesthesiology
Neurological 286847 286847 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this randomized double blind prospective clinical study we plan to evaluate the efficacy of adding Clonidine (30mcg), Dexmedetomidine (5mcg) or isotonic saline to 0.75% isobaric Ropivacaine for administration of subarachnoid lumbar block in infra-umbilical surgical procedures with regard to characteristics of sensory and motor block and observation of any side effects. Each of these treatments will be given on just one occasion Thereare three groups.
GROUP RS (Ropivacaine + Isotonic Saline) is the control group
They will be administered 3.0ml of 0.75% isobaric Ropivacaine + 0.2ml of Isotonic Saline (total volume of injectate 3.2ml)
GROUP RC (Ropivacaine + Clonidine)
They will be administered 3.0ml of 0.75% isobaric Ropivacaine + 30mcg of Clonidine (0.2ml Inj. Clonidine; total volume of injectate 3.2ml)
GROUP RD (Ropivacaine + Dexmedetomidine)
They will be administered 3.0ml of 0.75% isobaric Ropivacaine + 5mcg of Dexmedetomidine (0.05ml of Dexmedetomidine diluted to 0.2ml in isotonic saline; total volume of injectate 3.2ml)
Intervention code [1] 284945 0
Treatment: Drugs
Comparator / control treatment
1. GROUP RS (Ropivacaine + Isotonic Saline) is the control group
Control group
Placebo

Outcomes
Primary outcome [1] 287193 0
Duration of sensory block - it will be assessed clinically
Timepoint [1] 287193 0
Time to regression of sensory block to L1 dermatomal level
Primary outcome [2] 287201 0
Total duration of analgesia -- it will be assessed clinically
Timepoint [2] 287201 0
time between the injection and first request for analgesia
Secondary outcome [1] 297594 0
Total duration of motor block - clinical assessment
Timepoint [1] 297594 0
time from initial onset until complete recovery
Secondary outcome [2] 297625 0
Time to onset of sensory block to T10 and T8 dermatomal levels
Timepoint [2] 297625 0
time between injection and no sensation to prick at T10 and T8 levels

Eligibility
Key inclusion criteria
Patients scheduled to undergo elective infra-umbilical surgery
ASA grades 1 and 2
height : 150 to 180 cms
Duration of surgery not exceeding 2 1/2 hours
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal
ASA grades 3 and 4
Contraindications to spinal anaesthesia (absolute and relative)
Patients with the following cardiovascular disorders:
Heart rate < 55 beats/min
Patients on antihypertensive drug therapy
Those on heparin therapy, aspirin and other anti-platelet drug therapy
Hepatic and renal disorders
Obesity
pregnancy
Psychosis, dementia and other co-operation disorders
Peripheral neuropathy
Demyelinating central nervous system disorders
Disorders of spine eg. scoliosis
Chronic analgesic usage
Known hypersensitivity to drugs

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2012
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] 4334 0
India
State/province [1] 4334 0
delhi

Funding & Sponsors
Funding source category [1] 285325 0
Hospital
Name [1] 285325 0
safdarjung hospital
Country [1] 285325 0
India
Primary sponsor type
Hospital
Name
safdarjung hospital
Address
epartment of anaesthesia
safdarjung hospital,
new delhi-110029
Country
India
Secondary sponsor category [1] 284179 0
Individual
Name [1] 284179 0
dr kapil gupta
Address [1] 284179 0
Assistant Professor, Department of Anaesthesia and Critical care,
V.M.M.C & Safdarjung Hospital, New Delhi-110029, INDIA
Country [1] 284179 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287341 0
safdarjung hospital ethics committee
Ethics committee address [1] 287341 0
safdarjung hospital,
new delhi -110029
Ethics committee country [1] 287341 0
India
Date submitted for ethics approval [1] 287341 0
Approval date [1] 287341 0
01/10/2011
Ethics approval number [1] 287341 0

Summary
Brief summary
In this randomized double blind prospective clinical study we plan to evaluate the efficacy of adding Clonidine (30mcg), Dexmedetomidine (5mcg) or isotonic saline to 0.75% isobaric Ropivacaine for administration of subarachnoid lumbar block in infra-umbilical surgical procedures with regard to characteristics of sensory and motor block and observation of any side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34228 0
Address 34228 0
Country 34228 0
Phone 34228 0
Fax 34228 0
Email 34228 0
Contact person for public queries
Name 17475 0
dr kapil gupta
Address 17475 0
Dr Kapil Gupta,
Assistant Professor, Department of Anaesthesia and Critical care,
V.M.M.C & Safdarjung Hospital, New Delhi-110029, INDIA
Country 17475 0
India
Phone 17475 0
919811859019
Fax 17475 0
91-11-45626460
Email 17475 0
[email protected]
Contact person for scientific queries
Name 8403 0
dr kapil gupta
Address 8403 0
Dr Kapil Gupta,
Assistant Professor, Department of Anaesthesia and Critical care,
V.M.M.C & Safdarjung Hospital, New Delhi-110029, INDIA
Country 8403 0
India
Phone 8403 0
919811859019
Fax 8403 0
91-11-45626460
Email 8403 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.