Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001124628
Ethics application status
Approved
Date submitted
25/09/2014
Date registered
23/10/2014
Date last updated
17/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Dexmedetomidine Versus Nefopam for management of post spinal anesthesia shivering:A randomized double-blind controlled study
Scientific title
Dexmedetomidine Versus Nefopam for management of post spinal anesthesia shivering
Secondary ID [1] 285367 0
Nil
Universal Trial Number (UTN)
U1111-1161-9559
Trial acronym
D vs. N. In psash.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post spinal anesthesia shivering 293096 0
Condition category
Condition code
Anaesthesiology 293370 293370 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
dexmedetomidine in a dose of 0.5Ug/Kg intravenous(i.v.) or Nefopam in a dose of 0.15mg/Kg I.v. In the respective groups.each drug was diluted into 5 ml by isotonic saline and given by slow I.v.( one minute) at the onset of shivering.either of the two drugs was given according to the group in the postoperative spinal anesthesia period to patients who develop grade III or IV shivering . When shivering recures additional dose of either of the two drugs according to the group can be given as the same previous dose and recorded.
Intervention code [1] 290282 0
Treatment: Drugs
Comparator / control treatment
Dexmedetomidine group is being compared to Nefopam group.
Control group
Active

Outcomes
Primary outcome [1] 293233 0
Time of stoppage of postspinal anesthesia shivering after treatment with either dexmedetomidine or Nefopam.
Timepoint [1] 293233 0
We record shivering every minute after I. V. Injection of either dexmedetomidine or Nefopam for the first five minutes of the injections and record time of its stoppage after treatment.
Secondary outcome [1] 310650 0
Duration of effective postspinal analgesia after treatment with either dexmedetomidine or Nefopam. It is calculated from intrathecal bupivacaine injection to patient first request for rescue analgesic guided by visual analogue scale . Adverse effects are not outcome of the study.
Timepoint [1] 310650 0
Duration of effective postspinal analgesia from intrathecal bupivacaine administration to first rescue analgesic request.

Eligibility
Key inclusion criteria
ASA I and II patients scheduled for elective lower abdominal,lower limb , orthopedic and plastic surgeries under spinal anesthesia
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known hypersensitivity to dexmedetomidine or Nefopam,cardiopulmonary,renal or hepatic diseases,patients with a contra indication to spinal anesthesia e.g coagulation disorders,patients with failed or partial spinal block or those who do not agree to participate in the study

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Numerical data will be presented as mean+/- SD and categorical data as proportions. The unpaired t- test will be used for comparison of the means of all variables between the two groups.p. value of less than 0.05 will be considered statistically significant. We hypothesized that a detectable difference between the means of time taken for cessation of post spinal shivering after treatment with either dexmedetomidine or Nefopam = 180 seconds. If we estimated a S.D. For this prospective power analysis as 20%and an alpha value of 0.05,the power of the study would be 90%.Sample size calculated to be 45.7 patients per group .To increase the power we enrolled 50 patients per group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2014
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
1/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6368 0
Egypt
State/province [1] 6368 0
Qena

Funding & Sponsors
Funding source category [1] 290005 0
University
Name [1] 290005 0
South valley university( SVU).
Country [1] 290005 0
Egypt
Primary sponsor type
University
Name
South valley university
Address
South valley university-Qena-postal code 85823
Country
Egypt
Secondary sponsor category [1] 288688 0
None
Name [1] 288688 0
Nil
Address [1] 288688 0
Nil
Country [1] 288688 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291711 0
Qena faculty of medicine ethics committee
Ethics committee address [1] 291711 0
Ethics committee country [1] 291711 0
Egypt
Date submitted for ethics approval [1] 291711 0
01/09/2014
Approval date [1] 291711 0
10/09/2014
Ethics approval number [1] 291711 0

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

Contacts
Principal investigator
Name 51526 0
Dr Hatem saber Mohamed
Address 51526 0
Qena faculty of medicine- south valley university- postal code 85823-Qena.
Country 51526 0
Egypt
Phone 51526 0
+201005257062
Fax 51526 0
Email 51526 0
[email protected]
Contact person for public queries
Name 51527 0
Hatem saber Mohamed
Address 51527 0
Qena faculty of medicine- south valley university- postal code 85823-Qena.
Country 51527 0
Egypt
Phone 51527 0
+201005257062
Fax 51527 0
Email 51527 0
[email protected]
Contact person for scientific queries
Name 51528 0
Hatem saber Mohamed
Address 51528 0
Qena faculty of medicine- south valley university- postal code 85823-Qena.
Country 51528 0
Egypt
Phone 51528 0
+201005257062
Fax 51528 0
Email 51528 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
SourceTitleYear of PublicationDOI
EmbaseDexmedetomidine versus Nefopam for the management of post-spinal anesthesia shivering: A randomized double-blind controlled study.2015https://dx.doi.org/10.1016/j.egja.2015.06.004
N.B. These documents automatically identified may not have been verified by the study sponsor.