Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia

NCT ID: NCT04252820

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 215 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-08-04

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Prewarming during 15 minutes

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.

Group Type: EXPERIMENTAL

WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

Intervention Type: DEVICE

Forced-air warming will be applied in the preanesthetic room

Prewarming during 30 minutes

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.

Group Type: EXPERIMENTAL

WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

Intervention Type: DEVICE

Forced-air warming will be applied in the preanesthetic room

Prewarming during 45 minutes

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.

Group Type: EXPERIMENTAL

WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

Intervention Type: DEVICE

Forced-air warming will be applied in the preanesthetic room

Interventions

WarmTouch total body blanket, Covidien Ltd, Mansfield, USA

Forced-air warming will be applied in the preanesthetic room

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Negrin University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ángel Becerra

Principal Investigator, Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aurelio Rodríguez-Pérez, PhD

Role: STUDY_DIRECTOR

Dr Negrin UH

Locations

Ángel Becerra

Las Palmas de Gran Canaria, Las Palmas, Spain

Countries

Spain

Other Identifiers

RTU-Spinal

Identifier Type: -

Identifier Source: org_study_id