Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery

Sponsor

Koç University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06132490

Collaborator

(none)

111

Enrollment

Location

Arms

17.5

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Hemodynamic Instability Hypercapnia Complication,Postoperative Intraoperative Complications	Device: Conventional Insufflator with 12 mmHg intra-abdominal pressure Device: Valveless Insufflator with 12 mmHg intra-abdominal pressure Device: Valveless Insufflator with 8 mmHg intra-abdominal pressure	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

111 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

The patient and the pain nurses will be blind to the intervention due to the study design.

Primary Purpose:

Screening

Official Title:

Comparison of the Perioperative Effects of Intra-abdominal Pressure Created With Standard and Valveless Insufflators in Robotic Surgery

Actual Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional Patients scheduled for genitourinary or colorectal robotic surgery, conventional insufflators will be used with 12 mmHg intra-abdominal pressure.	Device: Conventional Insufflator with 12 mmHg intra-abdominal pressure In this group conventional insufflators, which have been in clinical practice for a long time, will be used under low intra-abdominal pressure throughout the surgery.
Experimental: Valveless 12 Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 12 mmHg intra-abdominal pressure.	Device: Valveless 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.
Experimental: Valveless 8 Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 8 mmHg intra-abdominal pressure.	Device: Valveless 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.

Arm

Intervention/Treatment

Active Comparator: Conventional

Patients scheduled for genitourinary or colorectal robotic surgery, conventional insufflators will be used with 12 mmHg intra-abdominal pressure.

Device: Conventional Insufflator with 12 mmHg intra-abdominal pressure

In this group conventional insufflators, which have been in clinical practice for a long time, will be used under low intra-abdominal pressure throughout the surgery.

Experimental: Valveless 12

Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 12 mmHg intra-abdominal pressure.

Device: Valveless 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.

Experimental: Valveless 8

Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 8 mmHg intra-abdominal pressure.

Device: Valveless 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.

Outcome Measures

Primary Outcome Measures

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.
Number of moments with surgical field vision loss [Intraoperative]
Number of camera cleanings and the number of sudden intraabdominal pressure drops will be recorded

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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