Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia

NCT04252820 | Completed

• 1 other identifier: RTU-Spinal
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative hypothermia is one of the most common anaesthetic complications, increasing the morbidity/mortality of our patients. Active prewarming with hot forced-air devices has demonstrated to be the most effective tool to prevent hypothermia, but its use is only recommended in long-term surgeries and the optimal prewarming duration has not been elucidated. Both spinal anaesthesia associated to the irrigation with liquids at low temperature instilled during transurethral resection (TUR) cause a decrease in the core temperature of the patient. This is a clinical trial comparing different time periods of prewarming in patients submitted to undergo elective transurethral resection. Our aim is to assess the effect of different time-periods of prewarming on preventing perioperative hypothermia during TUR with spinal anaesthesia. Investigators will compare different time periods: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes. 200 patients are going to be included in this study (50 patients in each group). Measurement of temperature will be performed using a tympanic thermometer and zero-heat-flux temperature sensor. Patients will be followed throughout their hospital admission. Data will be recorded using a validated instrument and will be analysed using the statistics program R Core Team.

Conditions

Hypothermia; Anesthesia; Perioperative Complication; Regional Anesthesia Morbidity; Temperature Change, Body; Transurethral Resection Syndrome

Keywords

body temperature; hypothermia; prewarming; regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor

  To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection under spinal anesthesia

  Throughout surgery, an average of 60 minutes.

Secondary Outcomes (3)

• Length of stay in postanesthetic care unit (in minutes)

  Stay in Post-Anesthetic Care Unit, an average of 6 hours.

• Postoperative pain, using visual analogue scale (from 0 to 10)

  Immediate postoperative period, an average of 1 hour.

• Postoperative shivering (using a dichotomous scale: yes or no)

  Immediate postoperative period, an average of 1 hour

Study Arms (4)

Control

NO INTERVENTION

No prewarming. Patients will be actively warmed during the intraoperative period. Tympanic thermometer and zero-heat-flux temperature sensor will be used to measure the temperature throughout the perioperative period.

Prewarming during 15 minutes

EXPERIMENTAL

Active Prewarming will be performed during 15 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period.

Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

Prewarming during 30 minutes

EXPERIMENTAL

Active Prewarming will be performed during 30 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period.

Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

Prewarming during 45 minutes

EXPERIMENTAL

Active Prewarming will be performed during 45 minutes, using a forced-air blanket over the whole body and connected to a forced-air warmer set up at 43 degrees centigrade. Patients will be actively warmed during the intraoperative period.

Device: WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

Interventions

WarmTouch total body blanket, Covidien Ltd, Mansfield, USA DEVICE

Forced-air warming will be applied in the preanesthetic room

Prewarming during 15 minutes; Prewarming during 30 minutes; Prewarming during 45 minutes

Eligibility Criteria

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

You may qualify if:

• Patients undergoing elective Transurethral resection under spinal anesthesia.
• Patients older tan 18 years old.
• American Society of Anesthesiologists physical status classification I - III.
• Absence of cognitive impairment.
• Written informed consent before enrollment.

You may not qualify if:

• Pregnancy.
• American Society of Anesthesiologists physical status classification IV.
• Active infection.
• Intake of antipyretics within 24 hours before surgery.
• Thyroid disorders.
• Skin lesions or History of hypersensitivity to skin contact devices.

Sponsors & Collaborators

• Dr. Negrin University Hospital: lead

Study Sites (1)

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

MeSH Terms

Conditions

Hypothermia; Body Temperature Changes; Transurethral resection syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aurelio Rodríguez-Pérez, PhD

  Dr Negrin UH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization will be carried out by a collaborator investigator using a computer program (Excel 2016) when a new patient is included into the clinical trial. This collaborator investigator will tell the nurse in charge of receiving the patient in the preanesthetic room how long prewarming has to be given to the patient: 0 minutes (no prewarming), 15 minutes, 30 minutes or 45 minutes, according to the group given by the computer program. This collaborator investigator will not provide clinical care to the patient. Attending anesthesiologist will be blind to the allocation of the participants. Principal investigator will not be able to know how long prewarming will be given.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist

Model Details: Different time periods of prewarming will be compared: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: March 1, 2020
• Primary Completion: August 4, 2020
• Study Completion: August 4, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)