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Efficacy of forced heating peri-induction of general anesthesia in preventing low body temperature in patients treated for robotic prostate removal surgery. Double-blind randomized controlled clinical trial

Efficacy of peri-induction forced warming in preventing hypothermia in patients undergoing robot-assisted prostatectomy. Double-blind randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2kx385d
Enrollment
Unknown
Registered
2023-03-07
Start date
2022-12-26
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia

Interventions

The selected participants will be patients submitted to robotic prostatectomy under combined anesthesia (spinal analgesia and total intravenous general anesthesia) with a minimum duration of 60 minute

Sponsors

Hospital Brasília
Lead Sponsor
Hospital Brasília
Collaborator

Eligibility

Sex/Gender
Male
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Men; Age between 50 and 80 years; physical status ASA I to III (classification related to the diseases the individual has); patients who will undergo elective robotic prostatectomy (removal of the prostate) under spinal analgesia and total intravenous general anesthesia; minimum surgical duration of 60 minutes

Exclusion criteria

Exclusion criteria: BMI >35 kg/m²; preoperative tympanic body temperature >38ºC or <36ºC; patients referred to the ICU (intensive care unit) in post-anesthesia recovery; surgeries lasting less than 60 minutes; patients who have uncompensated thyroid disease (thyroid disease that is not controlled by medication).

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of the forced peri-induction heating technique with a thermal mattress in the prevention of hypothermia, defined as a temperature <36.0ºC, during the intraoperative period for laparoscopic robotic prostatectomy. The evaluation will be done by measuring the temperature before, during and after the surgery, comparing the temperature variation of the patients in both groups (blanket and mattress). It is expected to find less incidence of hypothermia in the group that will use the mattress in the induction of general anesthesia.

Secondary

MeasureTime frame
To evaluate the impact of peri-induction heating with a thermal mattress on intraoperative temperature and in the first hour of post-anesthetic recovery. It is expected that the intervention group will have a faster recovery from the initial loss of temperature, and that the tympanic temperature of the individual in the intervention group will be higher in the recovery room than that of the individuals in the control group (thermal blanket).;To assess the impact of hypothermia on bleeding volume and the need for intraoperative and postoperative blood transfusions. The volume of content aspirated into the collector during surgery will be measured. In addition, postoperative bleeding will be assessed qualitatively by assessment in the recovery room and from medical records. The intervention group is expected to have less intraoperative bleeding and lower rates of related postoperative complications.;Evaluate hypothermia risk predictors in the perioperative context, based on individual characteristics of each participant (classification of physical status, weight, age, initial blood pressure, time to start surgery, initial temperature). It is expected that these factors are related to a higher risk of hypothermia and postoperative complications.;Measure the time between admission to the operating room and the start of surgery (pre-surgical preparation time) and the time to PACU discharge. This time will be correlated with the risk of developing hypothermia or not intraoperatively, in addition to being compared between the two groups for standardization and to avoid bias.;Identify the time to reach normothermia intraoperatively. A temporal analysis of the temperature evolution of individuals in both groups will be performed. Thus, a comparison can be made of how the change in temperature of the intervention and control groups evolved. The group with thermal mattress during induction is expected to reach temperatures closer to preoperative values ??more quickly than the

Countries

Brazil

Contacts

Public ContactAntônio Filipe Neto

Hospital Brasília

cet.hbr@hobra.com.br+55 (61) 37049396

Outcome results

None listed

Source: REBEC (via WHO ICTRP)