Intrathecal Additives to Prevent Post Spinal Shivering in Transurethral Prostatectomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 51
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group Dexamethasone; 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; prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives; Other Names: Intrathecal additives
Active Comparator: group Fentanyl; 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; prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives; Other Names: Intrathecal additives
Active Comparator: group Control; 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; prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives; Other Names: Intrathecal additives

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Study Chair: Abeer HM Elsawy, MD, Faculty of medicine,Zagazig University,Egypt

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 28, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Dexamethasone; Dexamethasone acetate; BB 1101; Fentanyl
• Other Study ID Numbers: transurethral prostatectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No