Warming IV Fluids and Incidence of Hypotension

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?

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02582112

Enrollment

Registered

2015-10-21

Start date

2010-09-30

Completion date

2015-10-31

Last updated

2016-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assault by Hot Fluids

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.

Interventions

OTHERActive Comparator: Warming group

Placebo Comparator: Control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 43 Years

Healthy volunteers

Inclusion criteria

* Inclusion criteria were previous cesarean delivery and breech presentation.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026