CClinicalTrials.gg
Status unknownNCT04178512Updated Dec 3, 2019

Intrathecal Additives to Prevent Post Spinal Shivering in Transurethral Prostatectomy

An interventional study of Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control in Anesthesia, sponsored by Zagazig University. Status unknown. Open to male participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by Zagazig University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
50 Years to 70 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugDrug: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

    Also known as: Intrathecal additives

06

What researchers measure

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

    Time frame: 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

    compare between both drugs as regards severity of shivering,hypothermia,hemodynamic changes and side effects of the used drugs

    Time frame: intraoperative and in the recovery room for 2 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04178512
Lead sponsor
Zagazig University
Responsible party
Fatma Mahmoud Ahmed (principal investigator, Zagazig University) — Principal investigator
First posted
Nov 26, 2019
Start date
Dec 2019 (estimated)
Primary completion
May 2020 (estimated)
Completion
Jun 2020 (estimated)
Last update
Dec 3, 2019

Study contacts

Fatma M Ahmed, MD
Contact
fatmakasem169@yahoo.com
+201095790313
Doaa M Farid, MD
Contact
+201222320115
Abeer HM Elsawy, MD
study chair · Faculty of medicine,Zagazig University,Egypt

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion