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Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia

Primary Purpose

Hypothermia; Anesthesia, Perioperative Complication, Regional Anesthesia Morbidity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
WarmTouch total body blanket, Covidien Ltd, Mansfield, USA
Sponsored by
Dr. Negrin University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia; Anesthesia focused on measuring body temperature, hypothermia, prewarming, regional anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Ángel Becerra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control

Prewarming during 15 minutes

Prewarming during 30 minutes

Prewarming during 45 minutes

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of stay in postanesthetic care unit (in minutes)
To assess the effect of prewarming in the length of stay in the Post-Anesthetic Care Unit of patients undergoing elective transurethral resection under spinal anesthesia.
Postoperative pain, using visual analogue scale (from 0 to 10)
To assess the effect of prewarming in reducing the postoperative pain at the arrival to the postanesthetic care unit of patients undergoing elective transurethral resection under spinal anesthesia
Postoperative shivering (using a dichotomous scale: yes or no)
To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing elective transurethral resection under spinal anesthesia

Full Information

First Posted
January 31, 2020
Last Updated
August 4, 2020
Sponsor
Dr. Negrin University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04252820
Brief Title
Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia
Official Title
Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
August 4, 2020 (Actual)
Study Completion Date
August 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Negrin University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Inadvertent perioperative hypothermia is probably the most common anaesthetic complication. Its appearance increases the morbidity of the surgical patient, increasing the incidence of cardiac events or perioperative blood loss and causes a greater time of recovery from anaesthesia. Prewarming is the most effective measure to prevent hypothermia and maintain intraoperative normothermia. However, prewarming in patients submitted to spinal anesthesia is still a weak recommendation and the optimal prewarming time has not been elucidated. Due to the searching of optimal prewarming time and the lack of evidence about the efficiency of prewarming in patients submitted to transurethral resection under spinal anaesthesia, the conductance of this clinical trial is justified.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia; Anesthesia, Perioperative Complication, Regional Anesthesia Morbidity, Temperature Change, Body, Transurethral Resection Syndrome
Keywords
body temperature, hypothermia, prewarming, regional anesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Different time periods of prewarming will be compared: 0 minutes (control group), 15 minutes, 30 minutes and 45 minutes
Masking
Care ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Prewarming during 15 minutes
Arm Type
Experimental
Arm Description
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.
Arm Title
Prewarming during 30 minutes
Arm Type
Experimental
Arm Description
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.
Arm Title
Prewarming during 45 minutes
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
WarmTouch total body blanket, Covidien Ltd, Mansfield, USA
Intervention Description
Forced-air warming will be applied in the preanesthetic room
Primary Outcome Measure Information:
Title
Differences in Body Temperature among different treatment groups using tympanic thermometer and zero-heat-flux temperature sensor
Description
To assess the effects of prewarming in preventing drop of body temperature of patients undergoing elective transurethral resection under spinal anesthesia
Time Frame
Throughout surgery, an average of 60 minutes.
Secondary Outcome Measure Information:
Title
Length of stay in postanesthetic care unit (in minutes)
Description
To assess the effect of prewarming in the length of stay in the Post-Anesthetic Care Unit of patients undergoing elective transurethral resection under spinal anesthesia.
Time Frame
Stay in Post-Anesthetic Care Unit, an average of 6 hours.
Title
Postoperative pain, using visual analogue scale (from 0 to 10)
Description
To assess the effect of prewarming in reducing the postoperative pain at the arrival to the postanesthetic care unit of patients undergoing elective transurethral resection under spinal anesthesia
Time Frame
Immediate postoperative period, an average of 1 hour.
Title
Postoperative shivering (using a dichotomous scale: yes or no)
Description
To assess the effect of prewarming in the prevalence of postoperative shivering of patients undergoing elective transurethral resection under spinal anesthesia
Time Frame
Immediate postoperative period, an average of 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurelio Rodríguez-Pérez, PhD
Organizational Affiliation
Dr Negrin UH
Official's Role
Study Director
Facility Information:
Facility Name
Ángel Becerra
City
Las Palmas De Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35019
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data are to be shared with other researchers when required once the study is completed and global data are published.

Learn more about this trial

Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia

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