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Trial registered on ANZCTR


Registration number
ACTRN12614000413628
Ethics application status
Approved
Date submitted
4/04/2014
Date registered
16/04/2014
Date last updated
22/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy Of Preoperative Hydrocortisone Versus Tramadol
For Attenuation Of Postoperative Shivering After Percutaneous Nephrolithotripsy
Scientific title
Efficacy Of Hydrocortisone Versus Tramadol
For Attenuation Of Postoperative Shivering After Percutaneous Nephrolithotripsy
Secondary ID [1] 284397 0
nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Shivering 291577 0
hypothermia 291578 0
Condition category
Condition code
Anaesthesiology 291956 291956 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group H, ( n =30) will receive IV hydrocortisone 2 mg/ kg.
Group T , (n =30) will receive IV tramadol hydrochloride 1 mg/ kg

The studied drug will be diluted in 10 ml coded
all will be given as an i.v. bolus just before induction of general anesthesia by an anesthesiologist who is unaware to the drugs given.
Intervention code [1] 289132 0
Prevention
Intervention code [2] 289133 0
Treatment: Drugs
Intervention code [3] 289191 0
Treatment: Other
Comparator / control treatment
Group S, ( n =30) will receive 10 ml normal saline IV.
Control group
Placebo

Outcomes
Primary outcome [1] 291857 0
Core temperature before induction of anesthesia then every 15 minutes after induction of anesthesia , and every 30 minutes in the PACU by
tympanic membrane temperature by Rossmax medical infrared ear thermometer, radiant innovation inc,Taiwan
Timepoint [1] 291857 0
before induction of anesthesia then every 15 minutes after induction of anesthesia , and every 30 minutes in the PACU
Primary outcome [2] 291858 0
Shivering intensity will be graded by using a five-point scale that was used in the study of Honarmand and Safavi.

(Grade 0: none; Grade 1: one or more areas of
piloerection but without visible muscular activity;
Grade 2: visible muscular activity confined to one muscle
group; Grade 3: same as Grade 2 but in more than
one muscle group; and Grade 4: gross muscular activity
involving the entire body).
Timepoint [2] 291858 0
Shivering intensity every 15 minutes in the first 2 hours postoperative
Secondary outcome [1] 307679 0
The incidence of shivering:number of patient have shivering
Timepoint [1] 307679 0
in the first 2 hours postoperative
Secondary outcome [2] 307680 0
Heart rate: ECG
Timepoint [2] 307680 0
intraoperative before
\anesthesia and every 15 min after anesthesia,
and every 30 min in the recovery room
Secondary outcome [3] 307681 0
hypertension :non invasive blood presure monitoring
Timepoint [3] 307681 0
intraoperative before
\anesthesia and every 15 min after anesthesia,
and every 30 min in the recovery room:non invasive blood presure monitoring

Eligibility
Key inclusion criteria
90 ASA I males and females patients aged 20-50 years old, planned for percutaneous nephrolithotripsy under general anesthesia.
Minimum age
20 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
had history of
hypertension, coronary artery disease, thyroid
dysfunction, diabetes, peptic ulcer, or on prolonged steroid
therapy, those with history of use of antidepressant drugs ,epilepsy ,a known allergy to the study drugs, expected blood transfusion during surgery, BMI >30 or an initial body temperature>38 degree C or <36 degree C.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis
30 patients in each group are selected based on
previous study:
Efficacy of prophylactic use of hydrocortisone and low
dose ketamine for prevention of shivering during
spinal anesthesia
Ashraf Abd Elmawgood a,*, Samaa Rashwan b, Doaa Rashwan
Egyptian Journal of Anaesthesia (2012) 28, 217–221

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/05/2014
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] 5965 0
Egypt
State/province [1] 5965 0

Funding & Sponsors
Funding source category [1] 289043 0
University
Name [1] 289043 0
egypt ,benisuef governerate benisuef university mokbel
Country [1] 289043 0
Egypt
Primary sponsor type
Hospital
Name
benisuef university hospital
Address
egypt,

benisuef university,faculty of medicine

-,mokbel,mohamad anwar hassan street, 62511
Country
Egypt
Secondary sponsor category [1] 287713 0
None
Name [1] 287713 0
Address [1] 287713 0
Country [1] 287713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290840 0
research ethical comittee
Ethics committee address [1] 290840 0
benisuef university faculty of medecine
(FMBSU)
egypt,



-,mokbel,mohamad anwar hassan street, 62511
Ethics committee country [1] 290840 0
Egypt
Date submitted for ethics approval [1] 290840 0
06/04/2014
Approval date [1] 290840 0
20/05/2014
Ethics approval number [1] 290840 0

Summary
Brief summary
After approval of the ethical committee in Benisuef university hospital (Egypt), a written informed consent will be obtained from 90 ASA I males and females patients aged 20-50 years old, planned for percutaneous nephrolithotripsy under general anesthesia.

Patients will be excluded from the study if they had history of
hypertension, coronary artery disease, thyroid
dysfunction, diabetes, peptic ulcer, or on prolonged steroid
therapy, those with history of use of antidepressant drugs ,epilepsy ,a known allergy to the study drugs, expected blood transfusion during surgery, BMI >30 or an initial body temperature>38 degree C or <36 degree C.

On arrival to the operating theatre, 18 G intravenous cannula will be inserted and IV warmed crystalloid fluids will be infused at a rate of 8 ml/kg

The patients will be randomly divided using closed envelope
technique for randomization to one of three groups:

Group S, ( n =30) will receive 10 ml normal saline IV.
Group H, ( n =30) will receive IV hydrocortisone 2 mg/ kg.
Group T , (n =30) will receive IV tramadol hydrochloride 1 mg/ kg

The studied drug will be diluted in 10 ml coded
all will be given as an i.v. bolus just before induction of general anesthesia by an anesthesiologist who is unaware to the drugs given.
With adjustment of the temperature in operating room at
22 degree C -24 degree C, the monitor will be attached to the patients to take preoperative readings of heart rate, non-invasive arterial blood pressure,Spo2.
General anesthesia will be induced after preoxygenation for 3- 5 minute with 100% oxygen by facemask, then induction of anesthesia in all patients will be with the use of i.v.propofol 2 mg/ kg, fentanyl 2 microgram / kg, atracurium (0.5mg/kg) and will be ventilated manually with sevoflorane 2 volume % ,oxygen 100% via a face mask then oral cuffed endotracheal tube.Muscle relaxation will be guided by nerve stimulator ( Life-Tech EZstimII), anesthesia will be maintained with oxygen 100%, sevoflorane, ,additional doses of atracurium, mechanical ventilation with maintenance of endtidal carbondioxide 35-40mmHg.
The patients will be well covered with sheets and sterile surgical drapes.
And all intravenous fluids and irrigation fluids will be warmed.
At the end of surgery, neuromuscular blockade will be reversed with IV neostigmine 0.04mg/kg and atropine 0.02 mg/kg, the trachea will be extubated when the patient respond to commands, all patients will be transferred to PACU, where they received oxygen via face mask 3-4 L/min and will be monitored and covered with cotton blanket .

The following parameters will be evaluated and recorded by senior anesthesia resident unaware of the study protocol:

1. Patient characteristics and operation time.
2. Core temperature before induction of anesthesia then every 15 minutes after induction of anesthesia , and every 30 minutes in the PACU bye
(tympanic membrane temperature by Rossmax medical infrared ear thermometer, radiant innovation inc,Taiwan)
3. Shivering intensity in the first 2 hours postoperative will be graded by using a five-point scale that was used in the study of Honarmand and Safavi.

(Grade 0: none; Grade 1: one or more areas of
piloerection but without visible muscular activity;
Grade 2: visible muscular activity confined to one muscle
group; Grade 3: same as Grade 2 but in more than
one muscle group; and Grade 4: gross muscular activity
involving the entire body). If shivering grades P 3 was
observed after anesthesia the patients were treated with
i.v. meperidine 25 mg
4. The incidence of shivering.
5. Number of patients requiring meperidine.
6. Heart rate, mean arterial blood pressure, and peripheral
oxygen saturation recorded (intraoperative before
\anesthesia and every 15 min after anesthesia,
and every 30 min in the recovery room).
7. Side effects:
– nausea and vomiting
– hypotension (decrease in MAP> 20% from preoperative
reading and was treated by i.v. fluids and ephedrine
5 mg i.v.)
– hypertension (increase in MAP >20% from preoperative
reading),
– tachycardia (increase in HR > 20% from preoperative
reading,
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47542 0
Dr doaa rashwan
Address 47542 0
doaa rashwan egypt benisuef governerate mokbel egypt, benisuef university,faculty of medicine -,mokbel,mohamad anwar hassan street, 62511
Country 47542 0
Egypt
Phone 47542 0
+20822318605
Fax 47542 0
Email 47542 0
doaa_rashwan2007@yahoo.com
Contact person for public queries
Name 47543 0
Dr doaa rashwan
Address 47543 0
doaa rashwan egypt benisuef governerate mokbel egypt, benisuef university,faculty of medicine -,mokbel,mohamad anwar hassan street, 62511
Country 47543 0
Egypt
Phone 47543 0
+20822318605
Fax 47543 0
Email 47543 0
doaa_rashwan2007@yahoo.com
Contact person for scientific queries
Name 47544 0
Dr doaa rashwan
Address 47544 0
doaa rashwan egypt benisuef governerate mokbel egypt, benisuef university,faculty of medicine -,mokbel,mohamad anwar hassan street, 62511
Country 47544 0
Egypt
Phone 47544 0
+20822318605
Fax 47544 0
Email 47544 0
doaa_rashwan@hotmail.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
SourceTitleYear of PublicationDOI
EmbaseEfficacy of preoperative hydrocortisone versus tramadol for attenuation of postoperative shivering after percutaneous nephrolithotripsy: A randomized controlled trial.2015https://dx.doi.org/10.1016/j.egja.2015.04.004
N.B. These documents automatically identified may not have been verified by the study sponsor.