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?

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.

Study Overview

• Status: Completed
• Conditions: Assault by Hot Fluids
• Intervention / Treatment: Other: Active Comparator: Warming group

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Adana, Turkey, 01330
    • Hakki Unlugenc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Other: Active Comparator: Warming group; Placebo Comparator: Control group
Active Comparator: Warming group; Active Comparator: Warming group	Other: Active Comparator: Warming group; Placebo Comparator: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hakki Unlugenc
• Investigators: Study Director: Hakkı Ünlügenç, Prof Dr, Cukurova University

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 21, 2015

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: HZLTNS98