Akademik Veri Yönetim Sistemi
International Journal of Clinical Trials, cilt.8, sa.4, ss.315-322, 2021 (Hakemli Dergi)
Background: This study aims to investigate the effects of individual and combined use of intraoperative forced-air
warming and warmed intravenous and irrigation fluids on post-operative body temperature, shivering, thermal
comfort, pain, nausea and vomiting in adult patients receiving general anaesthesia.
Methods: This is a randomised controlled clinical trial. A 2x2 factorial design will used in the experiment. Eligible
patients will be randomly assigned to one of four groups. We attempt to report this randomized controlled trial to
comply with the spirit. The study population will consist of 120 adult patients receiving general anaesthesia at
university hospitals in Turkey. After the induction of anaesthesia, the first group (n=30) will be warmed with only
forced-air warming device, the second group (n=30) will receive only warmed intravenous and irrigation fluids,
forced-air warming as well as warmed intravenous (IV) and irrigation fluids will be applied to the third group (n=30),
the fourth group (n=30) will consist of the control group without any intervention. Blood and blood products to be
applied intraoperatively to all groups will be heated to 37°C.
Conclusions: The primary outcome measures are post-operative body temperature, shivering, thermal comfort, pain,
nausea and vomiting. The primary results will be subjected to a one-way analysis of variance for covariant such as
amount of bleeding and volume of intraoperative fluids.
Trial registration: The trial has been registered in clinical trials: https://clinicaltrials.gov/. Registration number:
NCT04907617).
Keywords: General anesthesia, Hypothermia, Pain, Post-operative nausea and vomiting.