Last reviewed · How we verify
NCT04252820
Prevention of Perioperative Hypothermia in Transurethral Resection Under Spinal Anaesthesia
NA trial testing WarmTouch total body blanket, Covidien Ltd, Mansfield, USA in Hypothermia; Anesthesia in 215 participants. Completed in 4 August 2020.
4 August 2020
Quick facts
| Lead sponsor | Dr. Negrin University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 215 |
| Start date | 1 March 2020 |
| Primary completion | 4 August 2020 |
| Estimated completion | 4 August 2020 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- WarmTouch total body blanket, Covidien Ltd, Mansfield, USA
Conditions studied
- Hypothermia; Anesthesia — all drugs for Hypothermia; Anesthesia →
- Perioperative Complication — all drugs for Perioperative Complication →
- Regional Anesthesia Morbidity — all drugs for Regional Anesthesia Morbidity →
- Temperature Change, Body — all drugs for Temperature Change, Body →
Sponsor
Dr. Negrin University Hospital
Who can join
18 and older, any sex, with Hypothermia; Anesthesia or Perioperative Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04252820
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypothermia; Anesthesia
Currently open trials in the same condition.
- NCT06543134 — Evaluation of The Relationship Between Perioperative Hypothermia and Emergence Agitation · recruiting
- NCT05015582 — Perioperative Warming Measures in Cesarean Delivery · NA · recruiting
Other Dr. Negrin University Hospital trials
Trials by the same sponsor.
- NCT07131228 — Changes in Portal Vein Pulsatility Variability During a Tidal Volume Challenge Can Predict Fluid Tolerance · not yet recruiting
- NCT06857513 — Post-ICU Syndrome Over Time in Patients With Respiratory Failure · not yet recruiting
- NCT06785389 — Influence of Preoperative Fear on Pain and Postoperative Outcomes · recruiting
- NCT06635915 — Ultrasound to Check the Position of the Nasogastric Tube · NA · recruiting
- NCT06386354 — Residual Neuromuscular Block in the Post-Anesthetic Unit and Postoperative Complications · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04252820 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Negrin University Hospital
- Last refreshed: 6 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04252820.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing