Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery

Not Applicable

Completed

• Conditions: Hypercapnia; Post Operative Pain; Hemodynamic Instability; Intraoperative Complications; Complication,Postoperative
• Interventions: Device: Valveless Insufflator with 12 mmHg intra-abdominal pressure; Device: Valveless Insufflator with 8 mmHg intra-abdominal pressure

• Registration Number: NCT06132490
• Lead Sponsor: Koç University

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.

Study Timeline

• Study Start: 2022-07-15
• Study First Submitted: 2023-03-20
• Status Verified: 2023-09
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-15
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valveless 12	Valveless Insufflator with 12 mmHg intra-abdominal pressure	Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 12 mmHg intra-abdominal pressure.
Valveless 8	Valveless Insufflator with 8 mmHg intra-abdominal pressure	Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 8 mmHg intra-abdominal pressure.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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
Urine output	Intraoperative and daily untill discharge	Kidney function will be monitored by using intraoperative and daily postoperative urine output (mL)
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
Heart rate	Intraoperative	Heart rate (beat per minute) will be compared among the groups
Mean blood pressure	Intraoperative	Mean arterial pressures (mmHg) will be compared among the groups.
Intraoperative bleeding	Intraoperative	Total bleeding level estimated by the surgical nurse will be recorded as milliliters at the end of the surgery
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.
Time to oral intake	Postoperative 3 days	Postoperative time to oral intake will be recorded
Creatinine levels	Preoperative and postoperative (up to one month)	Kidney function will be monitored by using daily creatinine levels (mg/dL)
Need for blood product transfusion	Intraoperative and daily untill discharge	Blood product transfusions will be recorded
Hemoglobin levels	Intraoperative and daily untill discharge	Intraoperative and daily postoperative hemoglobin levels will be recorded
Flatus time	Postoperative one week	Postoperative time to first flatus 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.

Trial Locations

Locations (1)

Koç University; 🇹🇷 Istanbul, Turkey