Intrathecal Additives to Prevent Post Spinal Shivering in Transurethral Prostatectomy

Study Overview
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Brief Summary
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Spinal anesthesia is the technique of choice in transurethral prostatectomy.However,one of the common complications of spinal anesthesia is shivering which is even exaggerated in patients undergoing transurethral prostatectomy.this high incidence is most probably caused by sympathetic block and use of large amount of irrigation fluid during surgery.There are two methods to reduce shivering.Previous studies showed that intrathecal fentanyl is an appropriate method to reduce shivering.Intrathecal dexamethasone could reduce shivering by regulating immune responses.

Detailed Description
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Shivering is an involuntary repetitive contractions of skeletal muscles that increases the basal metabolism and is considered to be a defense mechanism for regulating body temperature in adults . Post spinal shivering may cause discomfort to the patient,and may aggravate wound pain by stretching incisions and increases intracranial and intra ocular pressure.Shivering may increase tissue oxygen demand as much as 500% and is accompanied by increase in minute ventilation and cardiac output to maintain aerobic metabolism. Tympanic temperature will be recorded preoperatively,after establishment of spinal anesthesia,and every 15 minutes til the end of operation.Core temperature below 36.5 C is considered as hypothermia Shivering intensity will be assessed with a five -point scale validated by Crossly and Maharaj. Adverse events like hypotension,bradycardia, respiratory depression,nausea and vomiting will be recorded and treated.

Official Title
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Effect of Intrathecal Dexamethasone Versus Fentanyl on Post Spinal Shivering in Patients Undergoing Transurethral Prostatectomy

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA(American society of anesthesiologists) physical status grade I-II BMI(body mass index) less than 35 kg/m2 patients undergoing transurethral prostatectomy Exclusion Criteria: patient refusal. patients with contraindications to spinal anesthesia e.g coagulopathy,anti coagulant therapy,allergy to local anesthetic,psychological disorders,... patient with advanced cardiopulmonary diseases or thyroid diseases. patients on corticosteroids therapy or on Alpha2 blocker orAlcohol. patients with initial body temperature above 37.5 C or below 36.5 C.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group Dexamethasone<br>Patients will receive 8 mg of dexamethasone(2ml) in addition to 2ml of hyperbaric bupivacaine 0.5% (total volume 4 ml) intrathecal injection. | Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control<br>* prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives<br>* Other names: Intrathecal additives;|
| Active Comparator: group Fentanyl<br>patients will receive 20 microgram fentanyl(diluted in sterile normal saline0.9% to 2ml)in addition to 2ml of hyperbaric bupivacaine 0.5%(total volume 4 ml) intrathecal injection. | Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control<br>* prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives<br>* Other names: Intrathecal additives;|
| Active Comparator: group Control<br>patients will receive 2ml of sterile normal saline0.9% in addition to 2ml of hyperbaric bupivacaine o.5% (total volume 4 ml) intrathecal injection. | Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control<br>* prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives<br>* Other names: Intrathecal additives;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of shivering | compare between the effect of intrathecal dexamethasone and intrathecal fentanyl on the incidence of shivering in patients undergoing transurethral prostatectomy | intraoperative every 15 min till the end of surgery and in the recovery room for 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparative assessment between both drugs | compare between both drugs as regards severity of shivering,hypothermia,hemodynamic changes and side effects of the used drugs | intraoperative and in the recovery room for 2 hours |