Intra-abdominal Pressure and Insufflator Effects in Robotic Surgery

Koç University

Status: Completed

Conditions: Hemodynamic Instability; Intraoperative Complications; Hypercapnia; Complication,Postoperative; Post Operative Pain

Treatments: Device: Valveless Insufflator with 8 mmHg intra-abdominal pressure; Device: Valveless Insufflator with 12 mmHg intra-abdominal pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT06132490

2022.094.IRB1.040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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43 participants in 2 patient groups

Valveless 12

Experimental group

Description:

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

Treatment:

Device: Valveless Insufflator with 12 mmHg intra-abdominal pressure

Valveless 8

Experimental group

Description:

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

Treatment:

Device: Valveless Insufflator with 8 mmHg intra-abdominal pressure