Assault by Hot Fluids Clinical Trial
Official title:
Do Warming iv Fluids During the Management of Spinal- Induced Hypotension Decrease the Incidence of Hypotension and Reduce the Requirement of Fluid, Blood and Ephedrine?
This prospective, double-blinded, randomized, controlled study was undertaken to evaluate whether warming IV fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine and transfusion requirement and lower fluid consumption than use of room-temperature fluids (22 oC) in cesarean delivery patients undergoing spinal anesthesia.
Inadvertent perioperative hypothermia during cesarean delivery is not rare and frequently
neglected, despite the recommendations by clinical guidelines. Exposure to cold air and
infusing non-warmed intravenous (iv) fluids are the other main sources of inadvertent
hypothermia. Spinal anesthesia used during the cesarean delivery has also been demonstrated
to impair normal autonomic thermoregulatory control and extend inadvertent perioperative
hypothermia. Various measures such as pre-warming of patients or fluids before anesthesia,
peroperative warming of iv fluids and active/passive cutaneous warming techniques have all
been used to prevent or to reduce inadvertent perioperative hypothermia. This prospective,
double-blinded, randomized, controlled study was undertaken to evaluate whether warming IV
fluids (37 oC) resulted in lower incidence of hypotension, less ephedrine and transfusion
requirement and lower fluid consumption than use of room-temperature fluids (22 oC) in
cesarean delivery patients undergoing spinal anesthesia.
The hypothesis was that in elective caesarean delivery patients undergoing spinal
anesthesia, warming intravenous fluids, would reduce the incidence of hypotension, ephedrine
and transfusion requirement and volume consumption. Thus, the primary outcome measure of the
present study was the incidence of intraoperative maternal hypotension and ephedrine
requirement during spinal anaesthesia for caesarean section. Secondary outcome measures were
total volume consumption, blood loss, pain scores, shivering and maternal and foetal side
effects.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention