Intrathecal Additives to Prevent Post Spinal Shivering in Transurethral Prostatectomy

NCT ID: NCT04178512

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2020-06-30

Brief Summary

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

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.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control

Intervention Type: DRUG

prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives

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.

Group Type: ACTIVE_COMPARATOR

Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control

Intervention Type: DRUG

prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives

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.

Group Type: ACTIVE_COMPARATOR

Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control

Intervention Type: DRUG

prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Intrathecal additives

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fatma Mahmoud Ahmed

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abeer HM Elsawy, MD

Role: STUDY_CHAIR

Faculty of medicine,Zagazig University,Egypt

Central Contacts

Fatma M Ahmed, MD

Role: CONTACT

fatmakasem169@yahoo.com

+201095790313

Doaa M Farid, MD

Role: CONTACT

+201222320115

Other Identifiers

transurethral prostatectomy

Identifier Type: -

Identifier Source: org_study_id