Intrathecal Additives to Prevent Post Spinal Shivering in Transurethral Prostatectomy

NCT04178512 | Unknown

• 1 other identifier: transurethral prostatectomy
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• comparative assessment between both drugs

  intraoperative and in the recovery room for 2 hours

Study Arms (3)

group Dexamethasone

ACTIVE COMPARATOR

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

group Fentanyl

ACTIVE COMPARATOR

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

group Control

ACTIVE COMPARATOR

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

Interventions

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

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

Also known as: Intrathecal additives

group Control; group Dexamethasone; group Fentanyl

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA(American society of anesthesiologists) physical status grade I-II
• BMI(body mass index) less than 35 kg/m2
• patients undergoing transurethral prostatectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Abeer HM Elsawy, MD

  Faculty of medicine,Zagazig University,Egypt

  STUDY CHAIR

Central Study Contacts

Fatma M Ahmed, MD

CONTACT

+201095790313; fatmakasem169@yahoo.com

Doaa M Farid, MD

CONTACT

+201222320115

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: December 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 3, 2019

Record last verified: 2019-11