UnknownNot Applicable

Effect of Prewarming On Skin Temperature Changes

Turkey (Türkiye)60 participantsStarted 2021-10-05

Plain-language summary

In this randomized prospective single-blind study,American Society of Anesthesiologists physical status classification system ( ASA )I-II-III patients aged 50-80 years undergoing transurethral bladder resection will be randomly divided into two groups. First group will be covered with 41 centigrade degrees double layered cotton cloth. Second group will receive active prewarming. Core temperature of all patients will be monitorized via tympanic membrane. Skin temperature will be monitorized from 4 different body areas. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. Hemodynamic parameters will be recorded. Skin temperature will be monitorized before and after spinal anesthesia and changes will be recorded. Operation time, amount and temperature of irrigation fluids, transfusion requirement, discharge time from postoperative care unit will also be recorded. Shivering score and thermal comfort scale will be used. The two groups will be compared for the temperature changes.

Who can participate

Age range

50 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASA I-II-III * 50-80 years old * Patients scheduled for transurethral baldder resection Exclusion Criteria: * Female gender * Uncoordinated patients * Have coagulopathy, * Known allergies to drugs to be used, * Patients diagnosed with severe hypovolemia * Skin infection at the injection site. * Body mass index greater than 35m2/kg * patients with severe endocrinological disease * Patients with cardiovascular diseases * patients with severe aortic stenosis or severe mitral stenosis * patients with increased intracranial pressure

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

peripheral skin temperature at ( F0)

Timeframe: just after spinal anesthesia done

peripheral skin temperature at( S0)

Timeframe: just after spinal anesthesia done

peripheral skin temperature( T0)

Timeframe: just after spinal anesthesia done

peripheral skin temperature( M0)

Timeframe: just after spinal anesthesia done

peripheral skin temperature( F1)

Timeframe: 60 seconds after spinal anesthesia done

peripheral skin temperature( F2)

Timeframe: 120 seconds after spinal anesthesia done

peripheral skin temperature( F3)

Timeframe: 180 seconds after spinal anesthesia done

Trial details

NCT IDNCT05063292

SponsorBozyaka Training and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-10

Contact for this trial

Negin Nayebi, MD

+905541491707 negin.naebi@gmail.com

View on ClinicalTrials.gov More Spinal Anesthesia trials

Plain-language summary

Who can participate

Age range

50 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

peripheral skin temperature at ( F0)

Timeframe: just after spinal anesthesia done

peripheral skin temperature at( S0)

Timeframe: just after spinal anesthesia done

peripheral skin temperature( T0)

Timeframe: just after spinal anesthesia done

peripheral skin temperature( M0)

Timeframe: just after spinal anesthesia done

peripheral skin temperature( F1)

Timeframe: 60 seconds after spinal anesthesia done

peripheral skin temperature( F2)

Timeframe: 120 seconds after spinal anesthesia done

peripheral skin temperature( F3)

Timeframe: 180 seconds after spinal anesthesia done