About this trial
The purpose of this study is to investigate the effect of intraoperative blood glucose management based on real-time continuous glucose monitoring ( RT-CGM) on time in range (TIR) and postoperative recovery during pancreaticoduodenectomy. The primary outcome is intraoperative TIR. Additionally, it aims to compare the differences in other glucose metrics, quality of postoperative recovery, and 30-day postoperative complications and mortality between the two glycemic management methods .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18
Scheduled for pancreaticoduodenectomy
ASA classification I-III
Disqualifiers
Emergency surgery
scheduled for MRI the day before surgery
Allergy to CGM sensor
Communication barriers or refusal to participate
Trial design
Parallel
Treatments tested in this trial
RT-CGM
DeviceIn the RT-CGM group, patients will wear a CGM sensor the day before surgery. Before entering the operating room, capillary blood glucose will be measured and compared with CGM interstitial glucose values for calibration. The target range for intraoperative blood glucose management is 3.9-10.0 mmol/L, with arterial blood gas measurements required at least every 2 hours. Following the administration of insulin or glucose, arterial blood gases should be retested at least every hour. RT-CGM monitoring will also be employed during surgery. A tablet in the operating room will be configured with low and high glucose alerts set at 3.9 mmol/L and 10.0 mmol/L, respectively. When an alarm is triggered, arterial blood gases will be rechecked, and glucose levels will be adjusted based on the arterial blood glucose results. If interstitial glucose values do not reach the intervention threshold, arterial blood gas measurements are recommended every 30 minutes.
Control
DeviceIn the control group, patients will wear a CGM sensor the day before surgery. Before entering the operating room, capillary blood glucose will be measured and compared with CGM interstitial glucose values for calibration. The target range for intraoperative blood glucose management is 3.9-10.0 mmol/L, with arterial blood gas measurements required at least every 2 hours. Following the administration of insulin or glucose, arterial blood gases should be retested at least every hour. CGM monitoring will also be employed during surgery, but the CGM interstitial glucose readings and alerts will be masked during the operation. The final intraoperative glucose management approach will be determined by the anesthesiologist, considering the patient's condition and surgical circumstances. The anesthesiologist can choose the intravenous insulin adjustment protocol we recommend.
Treatment groups
Trial outcomes
Primary outcomes
Intraoperative time in range (TIR)
Time in range (TIR) from CGM generally refers to the percentage of time that glucose levels stay within a target range (3.9-10 mmol/L)
Secondary outcomes
Intraoperative insulin dosage
unit
Intraoperative time above range (TAR)
Time above range (TAR) from CGM generally refers to the percentage of time glucose levels exceed the upper limit of the target range (\>180 mg/dL).
Intraoperative time below range (TBR)
Time below range (TBR) from CGM generally refers to the percentage of time glucose levels fall below the lower limit of the target range (\<70 mg/dL).
Intraoperative mean glucose
The average glucose level recorded by the CGM over a specified period
Locations
Sponsors and contacts
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