Skip to main content
OpenTrials
Completed

NCT Number: NCT02582112

Warming IV Fluids and Incidence of Hypotension

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Hakki Unlugenc

Adana, 01330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Comparator: Warming group

Other

Placebo Comparator: Control group

Primary outcomes

  1. The primary outcome measure of the present study was the incidence of intraoperative maternal hypotension and ephedrine requirement during spinal anaesthesia for caesarean section

    Time frame: 6 months

    Systolic and diastolic blood pressures (mmHg) and Ephedrine and transfusion requirement (n /mg)

Secondary outcomes

  1. Secondary outcome measures were total volume consumption.

    Time frame: 6 months

    Total volume consumption (mL),

  2. Secondary outcome measures were pain scores

    Time frame: 6 months

    Pain scores (VRS),

  3. Secondary outcome measures were shivering and maternal and foetal side effects.

    Time frame: 6 months

    side effects such as shivering, nausea, vomiting, bradycardia, hypoxia (y/n)

Sponsors and collaborators

Lead sponsor

Hakki Unlugenc

Other

Registry information

Official study 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?

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2015
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.