Intrathecal Additives to Prevent Post Spinal Shivering in Transurethral Prostatectomy

November 28, 2019 updated by: Fatma Mahmoud Ahmed, Zagazig University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: intraoperative every 15 min till the end of surgery and in the recovery room for 2 hours
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
Time Frame: intraoperative and in the recovery room for 2 hours
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

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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