Effect of Preoperative Prewarming on Serum Lactate Levels in Patients Undergoing Elective Nephrectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorBeyzanur Aydoğdu

About this trial

The goal of this observational study is to learn whether warming patients before surgery, called "prewarming," affects blood lactate levels (a marker of how well tissues are getting oxygen) and recovery in adults having planned (elective) kidney removal surgery (nephrectomy).

The main questions this study aims to answer are:

* Does prewarming lower the rise in blood lactate seen during and after surgery? * Does prewarming affect time spent in the intensive care unit (ICU), the need for a blood transfusion, or the rate of complications after surgery?

Researchers will compare two groups of adults having this surgery. One group receives brief active warming before anesthesia (the "prewarming" group). The other group does not receive this warming (the "control" group). The anesthesia team decides whether to use prewarming and for how long, as part of routine care; the study does not change this decision. Researchers will compare the two groups to see whether prewarming is linked to lower lactate levels and better recovery.

Participants will:

* Receive their usual, routine surgery and anesthesia care * Have blood pressure, heart rate, body temperature, and blood tests, including lactate, checked before and after surgery, as already done in routine care * Have their ICU stay, need for blood transfusion, and any complications recorded

This study does not add any extra tests, procedures, or blood draws beyond routine clinical care.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for elective nephrectomy

Adults aged 18-90 years

ASA (American Society of Anesthesiologists) physical status classification I-III

Signed informed consent form

Disqualifiers

Emergency nephrectomy

Concurrent additional major surgical procedure planned in the same session

Age under 18 or over 90 years

ASA physical status classification IV or higher

Trial population

Adult patients aged 18-90 years, ASA I-III, undergoing elective nephrectomy (open or laparoscopic) at the study site, enrolled consecutively over a one-year period.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Preoperative active warming (prewarming)

    Device

    Application of an active warming device to the patient's body surface during operating room preparation, before induction of anesthesia, for approximately 10-15 minutes at the discretion of the anesthesia team. The decision to apply prewarming, and its duration, follows routine clinical practice and is not standardized by the study protocol.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Prewarming Group1 intervention
Group B: Control Group0 interventions

Trial outcomes

Primary outcomes

1

Change in Serum Lactate Concentration

Change in serum lactate concentration from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.

Time frame
From the preoperative assessment to 24 hours after surgery

Secondary outcomes

1

Change in Systolic and Diastolic Blood Pressure

Changes in systolic and diastolic arterial blood pressure from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.

Time frame
From the preoperative assessment to 24 hours after surgery
2

Change in Heart Rate

Change in heart rate from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.

Time frame
From the preoperative assessment to 24 hours after surgery
3

Change in Body Temperature

Change in body temperature from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.

Time frame
From the preoperative assessment to 24 hours after surgery
4

Change in Hemoglobin Level

Change in hemoglobin concentration from the preoperative assessment to the postoperative assessment, compared between the prewarming and control groups.

Time frame
From the preoperative assessment to 24 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beyzanur Aydoğdu

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Sponsor institution