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Trial registered on ANZCTR


Registration number
ACTRN12614001246673
Ethics application status
Approved
Date submitted
12/11/2014
Date registered
27/11/2014
Date last updated
27/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intravenous low dose Ketamine injection versus Dexmedetomidine infusion for prevention of intraoperative shivering during spinal anesthesia
Scientific title
Sixty patients of both sexes between 20 to 50 years old undergoing elective lower abdominal surgery and elective orthopedic lower limb surgery under spinal anesthesia receiving low dose ketamine injection versus dexmedetomidine infusion to control post-spinal shivering in a clinical trial study with dexmedetomidine advantage.
Secondary ID [1] 285651 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-spinal anesthesia shivering 293497 0
Condition category
Condition code
Anaesthesiology 293776 293776 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients included in group D received Dexmedetomidine infusion (loading dose of 1mcg/kg over 10 minutes followed by a maintenance dose of 0.4mcg/kg/h) started immediately after giving spinal anesthesia for elective lower abdominal surgeries and elective lower limb orthopedic surgeries to control post-spinal anesthesia shivering and maintained until completion of surgery.
Intervention code [1] 290594 0
Treatment: Drugs
Intervention code [2] 290643 0
Prevention
Comparator / control treatment
Patients included in group K received low dose ketamine injection (0.25mg/kg) given intravenously immediately after onset of spinal anesthesia to control post-spinal anesthesia shivering.
Control group
Active

Outcomes
Primary outcome [1] 293572 0
measurement of post-spinal anesthesia shivering using 5 points rating scale, with grade 0 indicating no shivering to grade 4 indicating gross muscle activity involving the whole body.
Timepoint [1] 293572 0
shivering score is measured 10 minutes after spinal anesthesia then every 10 minutes till end of operation.
Secondary outcome [1] 311392 0
measurement of hemodynamic parameters (heart rate from ECG monitor, temperature by axillary thermometer, mean arterial pressure by automated non-invasive blood pressure monitoring, SPO2 by pulse oximetry)
Timepoint [1] 311392 0
hemodynamic parameters are measured as a baseline before start of spinal anesthesia then every 10 minutes after spinal anesthesia till end of operation.
Secondary outcome [2] 311487 0
Sedation score
Timepoint [2] 311487 0
sedation score is assessed every 10 minutes after onset of ketamine injection or dexmedetomidine infusion till the end of operation.

Eligibility
Key inclusion criteria
Patients undergoing elective lower abdominal surgery and elective orthopedic lower limb surgery were included in the study. Patients selected were American Society of Anesthesiologists (ASA) I and II physical status.
Minimum age
20 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with thyroid disease, Parkinson's disease, dysautonomia, Raynaud's syndrome, cardiopulmonary disease, a history of allergy to the agents to be used, a need for blood transfusion during surgery, an initial core temperature > 37.5 degree C or < 36.5 degree C, a known history of alcohol use, use of sedative-hypnotic agents, use of vasodilators, or having contraindications to spinal anesthesia were excluded from the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

- Sealed envelopes were numbered according to the randomization tables.
- Packing, sealing and numbering of the envelops was performed by a neutral medical personnel (Under the supervision of doctors from the Department of Anesthesiology).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Methods of randomization:
Randomization of patients was done using a computerized program (SPSS).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The number of cases included in this study was simple randomly allocated into two groups (30 in each group).
Data were analyzed using Statistical Program for Social Science (SPSS) version 18.0. Quantitative data were expressed as mean +/- standard deviation (SD). Qualitative data were expressed as frequency and percentage.


Statistical analysis:
Sample size was calculated using PASS 11. Based on a pilot study, it was calculated that a sample size of 24 patients per group will achieve 80 % power to detect a 10 % decrease in the occurrence in shivering in the dexmedetomidine group compared to ketamine group. The significance level of the test was targeted at 0.0500 . Thirty patients per group were included to replace any dropouts.

The following tests were done:

1- Paired sample t-test of significance was used when comparing between related samples.

2- Chi-square (X2) test of significance was used in order to compare proportions between two qualitative parameters.

3- Probability (P-value):

– P-value less than or equal to 0.05 was considered
significant.

– P-value 0.01 was considered as highly significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6471 0
Egypt
State/province [1] 6471 0
Cairo

Funding & Sponsors
Funding source category [1] 290237 0
University
Name [1] 290237 0
Ain Shams university
Address [1] 290237 0
Ramsis street, Abbasia district, Cairo.
PO Box: 11539
Country [1] 290237 0
Egypt
Primary sponsor type
University
Name
Ain Shams university
Address
Ramsis street, Abbasia district, cairo.
PO Box:11539
Country
Egypt
Secondary sponsor category [1] 288944 0
None
Name [1] 288944 0
Address [1] 288944 0
Country [1] 288944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291940 0
local ethical committee of faculty of medicine, ain shams universty.
Ethics committee address [1] 291940 0
Ramsis street, Abbasia, Cairo.
PO Box:11539
Ethics committee country [1] 291940 0
Egypt
Date submitted for ethics approval [1] 291940 0
01/10/2012
Approval date [1] 291940 0
01/11/2012
Ethics approval number [1] 291940 0

Summary
Brief summary
Shivering is considered one of the most common adverse effects occurring during spinal anesthesia. Besides causing patient discomfort, shivering also interferes with patient monitoring and increases tissue oxygen demand. The present study was conducted to compare the effectiveness of iv low dose Ketamine (0.25mg/kg) and dexmedetomidine iv infusion in prevention of shivering during spinal anesthesia.

Dexmedetomidine infusion exerts a beneficial dual effect as an anti-shivering and sedating agent during spinal anesthesia without any major adverse reactions. Therefore, we concluded that dexmedetomidine infusion is a good choice and better than low dose ketamine during spinal anesthesia when shivering is considered a problem.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52734 0
Dr Mostafa Mansour Houssein
Address 52734 0
department of anesthesia and intensive care, faculty of medicine, Ain shams university.
Ramsis street, Abbasia district, Cairo.
PO Box: 11539
Country 52734 0
Egypt
Phone 52734 0
+201093322145
Fax 52734 0
N/A
Email 52734 0
mostafa_mansour361@hotmail.com
Contact person for public queries
Name 52735 0
Dr Mostafa Mansour Houssein
Address 52735 0
department of anesthesia and intensive care, faculty of medicine, Ain shams university.
Ramsis street, Abbasia district, Cairo.
PO Box: 11539
Country 52735 0
Egypt
Phone 52735 0
+201093322145
Fax 52735 0
N/A
Email 52735 0
mostafa_mansour361@hotmail.com
Contact person for scientific queries
Name 52736 0
Dr Mostafa Mansour Houssein
Address 52736 0
department of anesthesia and intensive care, faculty of medicine, Ain shams university.
Ramsis street, Abbasia district, Cairo.
PO Box: 11539
Country 52736 0
Egypt
Phone 52736 0
+201093322145
Fax 52736 0
N/A
Email 52736 0
mostafa_mansour361@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary