Hakki Unlugenc
Adana, 01330, Turkey (Türkiye)
NCT Number: NCT02582112
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.
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Notify Me18 year–43 year
Female
Interventional
Phase 1
Adana, 01330, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo Comparator: Control group
Time frame: 6 months
Systolic and diastolic blood pressures (mmHg) and Ephedrine and transfusion requirement (n /mg)
Time frame: 6 months
Total volume consumption (mL),
Time frame: 6 months
Pain scores (VRS),
Time frame: 6 months
side effects such as shivering, nausea, vomiting, bradycardia, hypoxia (y/n)
Hakki Unlugenc
Other
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?
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