Warming IV Fluids and Incidence of Hypotension

Phase 1

Completed

• Conditions: Assault by Hot Fluids

• Registration Number: NCT02582112
• Lead Sponsor: Hakki Unlugenc

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2015-07
• Study Completion: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-21
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome measure of the present study was the incidence of intraoperative maternal hypotension and ephedrine requirement during spinal anaesthesia for caesarean section	6 months	Systolic and diastolic blood pressures (mmHg) and Ephedrine and transfusion requirement (n /mg)

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures were shivering and maternal and foetal side effects.	6 months	side effects such as shivering, nausea, vomiting, bradycardia, hypoxia (y/n)
Secondary outcome measures were pain scores	6 months	Pain scores (VRS),
Secondary outcome measures were total volume consumption.	6 months	Total volume consumption (mL),

Trial Locations

Locations (1)

Hakki Unlugenc; 🇹🇷 Adana, Turkey