The main aim of this study is to compare the perioperative effects of different intra-abdominal pressures and different insufflators in patients undergoing robotic surgery at a 30-45 degree trendelenburg position.
Adult patients scheduled for robotic genitourinary or colorectal surgery are going to be enrolled in this study. Patients will be randomized in three groups. In group I, conventional insufflators will be used with 12 mmHg intra-abdominal pressure; in group II, valveless insufflators will be used with 12 mmHg intra-abdominal pressure and in group III, valveless insufflators will be used with 8 mmHg intra-abdominal pressure. Intraoperative data regarding airway pressures, lung compliance, hemodynamic parameters, arterial blood gas analysis, times of pressure loss and camera cleaning will be gathered. Each patient will receive a standardized anesthesia and analgesia procedure with a intravenous morphine patient controlled analgesia (PCA). Postoperative pain will be monitored at 1st, 3rd, 6th, 12th and 24th postoperative hours and morphine consumption rates will be recorded. Patient length of stay, time to first flatus, urine output, postoperative complications(graded by Clavien Dindo classification), preoperative and postoperative hemoglobin and creatinine levels will be filed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
43
In this group valveless insufflators, which are relatively new in clinical practice, will be used under low intra-abdominal pressure throughout the surgery.
In this group valveless insufflators, which are relatively new in clinical practice, will be used under ultra-low intra-abdominal pressure throughout the surgery.
Koç University
Istanbul, Turkey (Türkiye)
Number of manipulations done by the attending anesthesiologists
After the induction of general anesthesia, orotracheal intubation and arterial catheterization; a standard ventilation and anesthesia maintenance strategy will be applied. Every manipulation performed to keep the parameters monitored by the anesthesiologists within physiological limits will be recorded: ventilation frequency setting, remifentail infusion titration, administration of vasoactive agents, etc.
Time frame: Intraoperative
Arterial blood gas lactate levels
Arterial blood gas will be sampled at standardized times during the operation and lactate levels will be compared among the groups
Time frame: Intraoperative
Peak airway pressures
Peak airway pressures (cmH2O) will be compared among the groups
Time frame: Intraoperative
Mean airway pressures
Mean airway pressures (cmH2O) will be compared among the groups
Time frame: Intraoperative
Lung compliance
Lung compliance (mL/cmH2O) will be compared among the groups
Time frame: Intraoperative
End tidal carbon dioxide levels
End tidal carbon dioxide levels (mmHg) will be compared among the groups
Time frame: Intraoperative
Minute ventilation
Minute ventilation (L/minute) will be compared among the groups
Time frame: Intraoperative
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Systolic blood pressure
Systolic arterial pressures (mmHg) will be compared among the groups.
Time frame: Intraoperative
Diastolic blood pressure
Diastolic arterial pressures (mmHg) will be compared among the groups.
Time frame: Intraoperative
Mean blood pressure
Mean arterial pressures (mmHg) will be compared among the groups.
Time frame: Intraoperative
Heart rate
Heart rate (beat per minute) will be compared among the groups
Time frame: Intraoperative
Acute Postoperative Pain
Acute postoperative pain reported with numeric rating scale (0-10) will be recorded at postoperative 1st, 3rd, 6th, 12th and 24th hours with 0 meaning no pain and 10 meaning worst imaginable pain.
Time frame: Postoperative 24 hours
Postoperative morphine consumption
Intravenous morphine consumption (mg) will be recorded at postoperative 1st, 3rd, 6th, 12th and 24th hours
Time frame: Postoperative 24 hours
Anesthesia time and operative time
Anesthesia and operative times wil be recorded as minutes
Time frame: Intraoperative
Intraoperative bleeding
Total bleeding level estimated by the surgical nurse will be recorded as milliliters at the end of the surgery
Time frame: Intraoperative
Urine output
Kidney function will be monitored by using intraoperative and daily postoperative urine output (mL)
Time frame: Intraoperative and daily untill discharge
Creatinine levels
Kidney function will be monitored by using daily creatinine levels (mg/dL)
Time frame: Preoperative and postoperative (up to one month)
Hemoglobin levels
Intraoperative and daily postoperative hemoglobin levels will be recorded
Time frame: Intraoperative and daily untill discharge
Need for blood product transfusion
Blood product transfusions will be recorded
Time frame: Intraoperative and daily untill discharge
Number of participants with pulmonary complications
Pulmonary complications like atelectasis, pulmonary oedema, pleural effusion, pneumothorax, pneumonia, ventilatory failure will be recorded for each patient. And number of patients with pulmonary complications will be compared among the groups.
Time frame: Postoperative, up to one month
Flatus time
Postoperative time to first flatus will be recorded
Time frame: Postoperative one week
Time to oral intake
Postoperative time to oral intake will be recorded
Time frame: Postoperative 3 days
Number of participants with subcutaneous emphysema
Subcutaneous emphysema diagnosed with chest radiograph will be recorded
Time frame: Postoperative, up to one month
Length of hospital stay
Length of hospital stay will be recorded as hours
Time frame: Postoperative, up to one month
The Clavien-Dindo classification of surgical complications
Any postoperative complication will be graded by the Clavien-Dindo classification between I to V with I meaning any deviation from the postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions and V meaning death of a patient.
Time frame: Postoperative, up to one month