Complication,Postoperative, Hemodynamic Instability, Hypercapnia, Intraoperative Complications, Post Operative Pain
Conditions
Keywords
robotic surgery, intra-abdominal pressure, insufflator, postoperative pain, postoperative complications, intraoperative complications
Brief summary
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.
Detailed description
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.
Interventions
DEVICEValveless Insufflator with 12 mmHg intra-abdominal pressure
In this group valveless insufflators, which are relatively new in clinical practice, will be used under low intra-abdominal pressure throughout the surgery.
DEVICEValveless Insufflator with 8 mmHg intra-abdominal pressure
In this group valveless insufflators, which are relatively new in clinical practice, will be used under ultra-low intra-abdominal pressure throughout the surgery.
Sponsors
Koç University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
The patient and the pain nurses will be blind to the intervention due to the study design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Elective robotic surgery with intraabdominal insufflation and trendelenburg position (prostatectomy, hemicolectomy etc.) * ASA (American Society of Anesthesiologists) Physical Status I-II-III
Exclusion criteria
* Patients without consent * Emergency surgery * Bleeding diathesis * Pregnancy or lactation * Prior history of major abdominal/pelvic surgery * Chronic kidney disease * Chronic opioid consumption for chronic pain * Inability to communicate with the patient due to language barriers or mental status
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of manipulations done by the attending anesthesiologists | Intraoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial blood gas lactate levels | Intraoperative | Arterial blood gas will be sampled at standardized times during the operation and lactate levels will be compared among the groups |
| Peak airway pressures | Intraoperative | Peak airway pressures (cmH2O) will be compared among the groups |
| Mean airway pressures | Intraoperative | Mean airway pressures (cmH2O) will be compared among the groups |
| Lung compliance | Intraoperative | Lung compliance (mL/cmH2O) will be compared among the groups |
| End tidal carbon dioxide levels | Intraoperative | End tidal carbon dioxide levels (mmHg) will be compared among the groups |
| Minute ventilation | Intraoperative | Minute ventilation (L/minute) will be compared among the groups |
| Systolic blood pressure | Intraoperative | Systolic arterial pressures (mmHg) will be compared among the groups. |
| Diastolic blood pressure | Intraoperative | Diastolic arterial pressures (mmHg) will be compared among the groups. |
| Mean blood pressure | Intraoperative | Mean arterial pressures (mmHg) will be compared among the groups. |
| Heart rate | Intraoperative | Heart rate (beat per minute) will be compared among the groups |
| Acute Postoperative Pain | Postoperative 24 hours | 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. |
| Postoperative morphine consumption | Postoperative 24 hours | Intravenous morphine consumption (mg) will be recorded at postoperative 1st, 3rd, 6th, 12th and 24th hours |
| Anesthesia time and operative time | Intraoperative | Anesthesia and operative times wil be recorded as minutes |
| Intraoperative bleeding | Intraoperative | Total bleeding level estimated by the surgical nurse will be recorded as milliliters at the end of the surgery |
| Urine output | Intraoperative and daily untill discharge | Kidney function will be monitored by using intraoperative and daily postoperative urine output (mL) |
| Creatinine levels | Preoperative and postoperative (up to one month) | Kidney function will be monitored by using daily creatinine levels (mg/dL) |
| Hemoglobin levels | Intraoperative and daily untill discharge | Intraoperative and daily postoperative hemoglobin levels will be recorded |
| Need for blood product transfusion | Intraoperative and daily untill discharge | Blood product transfusions will be recorded |
| Number of participants with pulmonary complications | Postoperative, up to one month | 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. |
| Flatus time | Postoperative one week | Postoperative time to first flatus will be recorded |
| Time to oral intake | Postoperative 3 days | Postoperative time to oral intake will be recorded |
| Number of participants with subcutaneous emphysema | Postoperative, up to one month | Subcutaneous emphysema diagnosed with chest radiograph will be recorded |
| Length of hospital stay | Postoperative, up to one month | Length of hospital stay will be recorded as hours |
| The Clavien-Dindo classification of surgical complications | Postoperative, up to one month | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed