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Ketamine Clinical Trials


Efficacy Of Preoperative Hydrocortisone Versus Tramadol For Attenuation Of Postoperative Shivering After Percutaneous Nephrolithotripsy


To see complete record on anzctr.org.au, please visit this link

Id: ACTRN12614000413628

Organisation Name: benisuef university hospital

Overal Status: Recruiting

Start Date: 21/05/2014

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,

Countries:
  • Egypt
Conditions:
  • Postoperative Shivering
  • hypothermia


Total execution time in seconds: 0.080335140228271