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?
Verified date | February 2016 |
Source | Cukurova University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 43 Years |
Eligibility |
Inclusion Criteria: - Inclusion criteria were previous cesarean delivery and breech presentation. Exclusion Criteria: - Exclusion criteria included parturients younger than 18 and older than 43 years, significant coexisting disease such as preeclampsia or eclampsia, thyroid disorders, neurological disorders, increased risk of intra-operative hemorrhage (such as placenta accreta), and any contraindication to regional anaesthesia such as bleeding disorders or local infection. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Turkey | Hakki Unlugenc | Adana |
Lead Sponsor | Collaborator |
---|---|
Hakki Unlugenc |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure of the present study was the incidence of intraoperative maternal hypotension and ephedrine requirement during spinal anaesthesia for caesarean section | Systolic and diastolic blood pressures (mmHg) and Ephedrine and transfusion requirement (n /mg) | 6 months | No |
Secondary | Secondary outcome measures were total volume consumption. | Total volume consumption (mL), | 6 months | No |
Secondary | Secondary outcome measures were pain scores | Pain scores (VRS), | 6 months | No |
Secondary | Secondary outcome measures were shivering and maternal and foetal side effects. | side effects such as shivering, nausea, vomiting, bradycardia, hypoxia (y/n) | 6 months | No |