Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

In this prospective single-blind study, patients will be divided into 2 groups with computer-based randomization technique. All patients will have a fasting time of 2 hours for clear fluid and 6 hours for solid food. Patients will be taken to the premedication room before the operation. Written and verbal approval will be taken from all patients. Tympanic membrane will be used for core temperature measurement by Citizen ear thermometer,every 15 minutes.Adult skin temperature probe will be used for continuous peripheral temperature measurement from four different body areas (T1:Cervical7 (C7) dermatome, T2:C6 dermatome T3:Lumbar 5( L5 )dermatome, T4: L4 dermatome). The two groups will have an infusion of balanced electrolyte solution with a rate of 8 Mililitre/Kilogram/ hour(mL/kg/hour). Patients in Group I will be covered with a 41 centigrade degrees double layered cotton clothes. Patients in Group II will receive active prewarming with a forced-air warming blanket (WarmCare full body blanket) 30 minutes prior to the operation. 0.1 mg/kg intravenous (iv) midazolam hydrochloride will be administered for premedication. Patients will be transferred to operating room, covered with warmed double layered cotton clothes. Standard monitoring (pulse oximetry, noninvasive blood pressure, electrocardiography) will be applied to the patients. Core temperature and 4-points skin temperature measurements will be recorded. Patients will be delivered 2 Liter/minute oxygen with a nasal cannula. Iv hydration will be continued by room temperature balanced electrolyte solution with an infusion rate of 2mililiter/kilogram/hour. 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 in the sitting position. Then patients will be taken supine position. Hemodynamic measurements will be continued. Core temperature measurements will be done every 15 minutes. Peripheral skin temperature measurements will be continuous. 1st, 2nd ,3rd,4th ,5th ,6th, 7th, 8th, 9th and 10th minutes and every 5 minutes measurements will be recorded during the operation. Pinprick test will be used for sensorial block assessment. T10 sensorial block will be our goal. The time for adequate sensorial block (T10) will be recorded. The patients will be repositioned (lithotomy) before the beginning of surgery. 5 mg iv ephedrine and 0.5 mg iv atropine will be administered when the blood pressure will be %80 of the baseline pressure and heart rate. Operating time, amount and temperature of irrigation fluids, transfusion requirement will be recorded. All patients will be transferred to post anesthesia care unit (PACU). Core temperature measurements will be continued every 15 minutes at PACU. Shivering scale and thermal comfort scale will be used during and after the operation. 25 mg iv meperidine will be administered when the patient's shivering score will be more than 3. Length of PACU stay will be recorded. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05063292
Study type Interventional
Source Bozyaka Training and Research Hospital
Contact Negin Nayebi, MD
Phone +905541491707
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date October 5, 2021
Completion date November 18, 2021

See also
  Status Clinical Trial Phase
Completed NCT02565303 - Minimum Effective Dose of Ropivacaine for Spinal Anesthesia for Cesarean Delivery N/A
Recruiting NCT03248817 - Phenylephrine Infusion in Cesarean Delivery Phase 4
Completed NCT02840006 - Spinal Anesthesia Associated With General Anesthesia in Coronary Artery Bypass Phase 4
Completed NCT01624844 - Predictive Value of Ultrasound Measurement of the Dural Sac Volume on the Sensory Level in Spinal Anesthesia N/A
Recruiting NCT00974961 - Levobupivacaine on Heart Rate Variability (HRV) in Spinal Anesthesia Phase 4
Recruiting NCT00492453 - Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy N/A
Completed NCT03805503 - Chloroprocaine for Inguinal Herniorrhaphy Phase 4
Not yet recruiting NCT03883763 - Hyperbaric Novabupi® in Spinal Anesthesia in Lower Limbs Vascular Surgery Phase 3
Completed NCT03775655 - Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section Phase 2/Phase 3
Completed NCT03199170 - Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section N/A
Completed NCT03302039 - Three Protocols for Phenylephrine Administration in Cesarean Delivery Phase 4
Not yet recruiting NCT05002257 - Impact of Listening to Music on Anxiety Postoperative in a Postanesthesic Care Unit (PACU) After Spinal Anesthesia N/A
Recruiting NCT02937792 - Large Volume Bupivacaine 0.5% Versus Small Volume in Elective Caesarean Section N/A
Recruiting NCT01415284 - ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia Phase 4
Completed NCT00537472 - Low Dose Spinal Bupivacaine for Total Knee Replacement and Recovery Room Wait Time N/A
Completed NCT03322098 - Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia N/A
Recruiting NCT04598061 - IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
Completed NCT04083768 - Effect of Different Left Lateral Table Tilt for Elective Cesarean Delivery Under Spinal Anesthesia N/A
Completed NCT03702400 - Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery Phase 2
Terminated NCT03322150 - Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Adult Patients Undergoing Lower Extremity Surgery Under Spinal Anesthesia N/A