Low Gas Pressure vs Standard Gas Pressure in Robotic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
During surgery that is done using a robot, the surgeon needs to put carbon dioxide gas into the belly to lift the belly wall. This is done so the surgeon can adequately see all the body organs and operate safely. Many surgeons currently use a standard pressure of 15 mmHg (a unit to measure pressure). However, many patients find the use of this pressure to be painful after surgery. New research has shown that using a lower pressure with a device called "AirSeal" can safely reduce pain and lead to faster recovery after surgery.
The goal of this clinical trial is to learn if using a lower gas pressure with the AirSeal device during robotic surgery, compared to standard gas pressure with conventional devices, helps adults feel less pain and recover faster.
The study includes adults aged 18 or older having robotic at New York-Presbyterian Hospital/Weill Cornell Medical Center.
The main questions this clinical trial aims to answer are:
1. Does using lower gas pressure shorten the time people spend in the recovery room after surgery? 2. Does using lower gas pressure lead to less pain and reduce the need for pain medicine after surgery?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older
Scheduled to undergo robotic-assisted surgery at New York-Presbyterian/Weill Cornell Medical Center
American Society of Anesthesiologists physical status I-III
Able to understand and provide written informed consent in English
Disqualifiers
American Society of Anesthesiologists physical status IV or higher (i.e. a severe systemic disease that is a constant threat to life such as decompensated heart failure)
Chronic opioid use (≥30 morphine milligram equivalents per day for ≥30 days within the past 6 months)
Current pregnancy
Inability to understand and provide informed consent in English
Trial design
Design model
Parallel
Treatments tested in this trial
AirSeal Robotic Solution
DeviceThe experimental intervention is low-pressure pneumoperitoneum at 8 mmHg using the AirSeal Robotic Solution device. The AirSeal Robotic Solution (CONMED Corporation) is an FDA 510(k)-cleared carbon dioxide insufflation device that is indicated for use in robotic-assisted surgery. It consists of a console, tri-lumen filtered tube set, and access ports that function as valveless trocars. The console of the device is mounted on a cart and regulates carbon dioxide flow and smoke evacuation by continuously measuring the intra-abdominal pressure. The trilumen filtered tube set carries carbon dioxide to the abdomen, transmits pressure information back to the console, and returns gas from the abdomen for smoke evacuation and filtration. These features allow for the device to operate in the "AirSeal" mode, whereby the pressure within the abdomen is effectively kept constant. The valveless trocars are access ports for the minimally invasive tools to enter the abdominal cavity.
Standard-pressure pneumoperitoneum (15 mmHg)
Other interventionThe control intervention is standard-pressure pneumoperitoneum set at a pressure of 15 mmHg. This will be delivered using the operating room's conventional valved-trocar carbon dioxide insufflator.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Low-pressure pneumoperitoneum (AirSeal)Experimental treatment 1 intervention
Group B: Standard-pressure pneumoperitoneumActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average post-anesthesia care unit (PACU) length of stay in minutes from PACU admission to PACU discharge order
The PACU is the area where participants recover from anesthesia after surgery. The PACU recovery time will be computed in minutes as the interval between the documented PACU arrival timestamp and the documented PACU discharge-order timestamp which will both be abstracted from the institutional electronic medical record. The discharge-order timestamp represents the clinical decision that the participant is fit to leave the PACU and is therefore not confounded by factors such as transport delays.
Time frame
From PACU arrival (5 minutes post-surgery) to PACU discharge-order (1 to 4 hours post-surgery)Secondary outcomes
1
Average numeric rating scale (NRS) pain score (0-10) at PACU admission
Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10. 0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer. The pain scores will be taken from the participants within 5 minutes of documented PACU arrival.
Time frame
PACU arrival (5 minutes post-surgery)2
Average numeric rating scale (NRS) pain score (0-10) at PACU discharge
Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10. 0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer. The pain scores will be taken from the participants within 10 minutes of PACU discharge order time stamp.
Time frame
PACU discharge (1-4 hours post-surgery)3
Average numeric rating scale (NRS) pain score (0-10) at post-operative day 1 (POD1)
Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10. 0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer. The pain scores will be taken from the participants on POD1 between the hours of 08:00 and 12:00. If the participant is discharged, a telephone call will be made during those hours.
Time frame
Post-operative day 1 (24 hours after surgery)4
Average numeric rating scale (NRS) pain score (0-10) at post-operative day 3 (POD3)
Postoperative pain intensity is measured using a verbally administered numeric rating scale (NRS) ranging from 0 to 10. 0 indicates no pain while 10 indicates the worst pain that the participant can imagine or has experienced. The score will be recorded as an integer. The pain scores will be taken from the patients on POD3 between the hours of 08:00 and 12:00. If the participant is discharged, a telephone call will be made during those hours.
Time frame
Post-operative day 3 (72 hours after surgery)Sponsors and contacts
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Source ClinicalTrials.gov