CompletedNot Applicable

Optimal Temperature Control in Body Contouring Procedures

Colombia197 participantsStarted 2022-06-01

Plain-language summary

The goal of this clinical trial is to compare different strategies for normothermia prevention in patients undergoing body contouring and other Aesthetic Plastic Surgery procedures. The main question(s) it aims to answer are: * Do active measures have an impact on preventing hypothermia in patients undergoing cosmetic procedures? * Does an active normothermia prevention protocol have any impact in the clinical setting? Four different protocols will be used for patient peroperative preparation for normothermia.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing body contouring procedures (liposuction or liposculpture), either individually or combined with a maximum of two other major aesthetic procedures involving face, breast, or dermolipectomy. * Healthy patients without underlying comorbidities (classified as ASA≤II) Exclusion Criteria: * Women with BMI \>30 kg/m² * men with BMI \>32 kg/m² * Patients after massive weight loss * Smokers

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hypothermia prevention

Timeframe: Before induction, Immediately after intubation, at the end of surgery (inside the OR), Upon arrival to the recovery room, before discharge.

Pain intensity

Timeframe: Intensity of pain (measured in VAS scale) at the awakening at the recovery room and just before discharge.

Chills

Timeframe: Immediately at awakening at the recovery room.

Shivering

Timeframe: Immediately at awakening at the recovery room.

Recovery Period

Timeframe: Time interval, measured in minutes and hours, commencing from the patient's admittance into the Post-Anesthesia Care Unit (PACU) until their subsequent discharge.

Analgesic requirements

Timeframe: Number of doses of pain medication required during the patient's recovery period at the PACU, between 1-8 hours after surgery.

Trial details

NCT IDNCT06238739

SponsorTotal Definer Research Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-30

View on ClinicalTrials.gov More Hypothermia trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Hypothermia prevention

Timeframe: Before induction, Immediately after intubation, at the end of surgery (inside the OR), Upon arrival to the recovery room, before discharge.

Pain intensity

Timeframe: Intensity of pain (measured in VAS scale) at the awakening at the recovery room and just before discharge.

Chills

Timeframe: Immediately at awakening at the recovery room.

Shivering

Timeframe: Immediately at awakening at the recovery room.

Recovery Period

Timeframe: Time interval, measured in minutes and hours, commencing from the patient's admittance into the Post-Anesthesia Care Unit (PACU) until their subsequent discharge.

Analgesic requirements

Timeframe: Number of doses of pain medication required during the patient's recovery period at the PACU, between 1-8 hours after surgery.