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Warming IV Fluids and Incidence of Hypotension

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ClinicalTrials.gov Identifier: NCT02582112
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hakki Unlugenc, Cukurova University

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.

Condition or disease Intervention/treatment Phase
Assault by Hot Fluids Other: Active Comparator: Warming group Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
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?
Study Start Date : September 2010
Actual Primary Completion Date : July 2015
Actual Study Completion Date : October 2015

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Arm Intervention/treatment
Active Comparator: Warming group
Active Comparator: Warming group
Other: Active Comparator: Warming group
Placebo Comparator: Control group

Placebo Comparator: Control group
Control group
Other: Active Comparator: Warming group
Placebo Comparator: Control group




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582112


Locations
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Turkey
Hakki Unlugenc
Adana, Turkey, 01330
Sponsors and Collaborators
Hakki Unlugenc
Investigators
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Study Director: Hakkı Ünlügenç, Prof Dr Cukurova University

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Responsible Party: Hakki Unlugenc, Professor Dr, Cukurova University
ClinicalTrials.gov Identifier: NCT02582112     History of Changes
Other Study ID Numbers: HZLTNS98
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases