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Musculoskeletal Diseases

Digestive System Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Pain

Shoulder Pain

Pneumoperitoneum

Genital Neoplasms, Female

Peritoneal Diseases

Gastrointestinal Diseases

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Anesthetics

Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge.

Conventional Insufflation System (CIS) used for pneumoperitoneum during laparoscopic/robotic surgery.

Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge.

ConMed AirSeal Insufflation System (AIS) at Low Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.

Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge.

ConMed AirSeal Insufflation System (AIS) at Higher Pressure used for pneumoperitoneum during laparoscopic/robotic surgery.

Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge.

Questionnaires ask about pain level and any drugs taken for it. It should take about 5 minutes to complete.

Questionnaires

CIS with pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.

Conventional Insufflation System (CIS)

AIS with an insufflation pressure target of 9±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.

ConMed AirSeal Insufflation System (AIS) at Low Pressure

AIS with an insufflation pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.

ConMed AirSeal Insufflation System (AIS) at Higher Pressure

Pedro T. Ramirez, MD

The goal of this clinical research study is to compare the level of pain 2 hours after surgery in patients after the use of the AirSeal® Insufflation System (AIS) at a high or low pressure setting or the standard insufflator (the conventional insufflation system, or CIS). "Insufflation" is the creation of a pressure barrier of air/gas within the abdomen that allows the surgeon more space to work in.

Baseline Visit:

If participant agrees to take part in this study, within 30 days before surgery, participant will be asked to complete a questionnaire about participant's pain level and any drugs participant may be taking for it. It should take about 5 minutes to complete.

Study Groups:

Participant will be randomly assigned to 1 of 3 groups (as in a roll of dice). This is done because no one knows if one study group is better, the same, or worse than the other group. Participant has an equal chance of being placed in each group. Participant will not know which group participant is assigned to.

* If participant is in Group 1, participant will have the CIS used during surgery.
* If participant is in Group 2, participant will have the AIS used at a lower pressure during surgery.
* If participant is in Group 3, participant will have the AIS used at a higher pressure during surgery.

Surgery:

Participant will then have surgery. Participant will sign a separate consent for the surgery that explains the procedure, the risks of the surgery, and the risks of CIS.

Blood (about 3 teaspoons each time) will be collected 1 time before surgery, 2 times during surgery, and 1 time after surgery is completed. Routine tests and tests to learn how participant's body reacts to inflammation will be performed on this blood.

Questionnaires:

After surgery, participant will complete the questionnaire about participant's pain level and any drugs participant is taking. Participant will complete this questionnaire:

* Two (2) hours after surgery,
* When participant leaves the post-anesthesia care unit (PACU), and
* When participant is discharged from the hospital

If participant is discharged the same day as participant's surgery, participant will be called by the study staff to answer the questionnaire the following day.

Length of Study Participation:

Participation in the study will be over after participant completes the questionnaire after participant is discharged, unless participant agrees to complete additional optional questionnaires.

This is an investigational study. Both AirSeal® insufflation system (AIS) and conventional insufflation systems (CIS) are FDA approved and commercially available. It is investigational to compare the effects of high and low pressures using the AIS.

Up to 240 participants will be enrolled in this study. All will take part at MD Anderson.

Pneumoperitoneum Management With Low vs. Higher Pressure

A Single Center, Prospective, Randomized, Controlled Study to Evaluate Shoulder Pain, Cardiovascular Changes, Pulmonary Pressures and Perioperative Outcomes Related to the Use of the AirSeal® Insufflation System (AIS) at Low and Higher Pressure Pneumoperitoneum vs. Conventional Insufflation

Incidence of shoulder pain defined by a positive (\>0) score for an 11-point pain intensity numeric rating scale (PI-NRS).

CONMED Corporation

M.D. Anderson Cancer Center

Anti-Arrhythmia Agents

Channel Blockers

Adjuvants, Anesthesia

Analgesics

Other Dietary Supplements

Lidocaine

Fentanyl

Rocuronium

Ketamine

Propofol

Isoflurane

Anesthetics, Inhalation

Benzocaine

Narcotics

Tannic Acid

Induction with 1% propofol (2-3 mg/kg), fentanyl (1-3 mg/kg), and Rocuronium 1-1.5 mg/kg. Before the injection of propofol, 5 mL 1% lidocaine (50 mg) to limit any discomfort caused by the propofol injection. After endotracheal intubation, intravenous infusion of propofol, lidocaine, ketamine or narcotic as deemed appropriate by anesthesiologist. There will be no inhalation anesthetic used. Ventilation with oxygen and air mixture (50%/50%) and titrated to keep the mean arterial pressure within 20% of its preinduction value. Muscle relaxation maintain using Aliquots of rocuronium to 0 to 1 train-of-4 twitch response of adductor pollicis. During surgery, mechanical ventilation using pressure-controlled mode (peak inspiratory pressure 30 cm H2O). We aim for Tidal volume of 5-7 ml/Kg of ideal body weight with a positive end-expiratory pressure of 5 cm H2O, and a respiratory rate to maintain end-tidal carbon dioxide between 30 to 40 mm Hg.

Induction with 1% propofol (2-3 mg/kg), fentanyl (1-3 mg/kg), and Rocuronium 1-1.5 mg/kg. Before the injection of propofol, 5 mL 1% lidocaine (50 mg) to limit any discomfort caused by the propofol injection. After endotracheal intubation, the depth of anesthesia will be maintained at a minimum alveolar concentration of 1 to 1.25 using isoflurane in oxygen and air mixture (50%/50%) and titrated to keep the mean arterial pressure within 20% of its preinduction value. Muscle relaxation maintain using Aliquots of rocuronium to 0 to 1 train-of-4 twitch response of adductor pollicis. During the surgery, subjects will be mechanically ventilated using pressure-controlled mode (peak inspiratory pressure 30 cm H2O). We aim for Tidal volume of 5-7 ml/Kg of ideal body weight with a positive end-expiratory pressure of 5 cm H2O, and a respiratory rate to maintain end-tidal carbon dioxide between 30 to 40 mm Hg.

Induction with 1% propofol (2-3 mg/kg), fentanyl (1-3 mg/kg), and Rocuronium 1-1.5 mg/kg. Before the injection of propofol, 5 mL 1% lidocaine (50 mg)

TIVA

Induction with 1% propofol (2-3 mg/kg), fentanyl (1-3 mg/kg), and Rocuronium 1-1.5 mg/kg. Before the injection of propofol, 5 mL 1% lidocaine (50 mg

Balanced anesthesia

Sonia Mehta, MD

Anna Woods

Steep Trendelenburg positioning and insufflation of the abdominal cavity have shown to increase intra ocular pressure. Different anesthetic techniques can alter intra ocular pressure and a small pilot study showed decrease in Intraocular Pressure (IOP) in robotic case in steep Trendelenburg with IV anesthetics (TIVA).

We want to quantify the degree of change in Intraocular Pressure (IOP) in female patients undergoing robotic procedures for cancer. We want to detect the difference in increase of pressure with total IV anesthesia versus conventional balanced anesthesia

During the day of surgery, the anesthesiologist trained by an ophthalmologist, will measure each eye's Intraocular Pressure (IOP) using a tonometer for both the Trendelenburg with IV anesthetics (TIVA) and propofol/fentanyl/rocuronium arms of the study. (The Tono-Pen XL Medtronic Solan, Jacksonville, FL) The Intraocular Pressure (IOP) for both eyes will be measured at seven time points:

Time 1 induction after administration of sedative and local anesthesia in the eye. Both eyes of the patient will anesthetized using topical proparacaine hydrochloride ophthalmic solution 0.5%.

Time 2 Post induction table 0 degrees Time 3 Supine after pneumoperitoneum with 14 mmHg pressure Time 4 After docking robot at correct Trendelenburg positioned measured by a level Time 5 After undocking and before moving supine Time 6 Supine and before extubation. If the intraocular pressure remains elevated above 19 mmHg will require a 7th measurement in PACU with HOB at 30 degrees and if the pressure still at or above 19 ophthalmology consult initiated.

Time 7 if needed, see above

If the patient has any increased reading at the end of the procedure, the same attending anesthesiologist in the post-operative recovery area prior to discharge will do a post op measurement. Any abnormal readings will prompt an ophthalmology consult and follow up with ophthalmology department.

Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients

quantify the degree of change in IOP in female patients undergoing robotic procedures for cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pneumoperitoneum Management With Low vs. Higher Pressure	NCT03128281	Malignant Neopl...	Questionnaires Conventional In... ConMed AirSeal ... ConMed AirSeal ...	18 Years - 80 Years	M.D. Anderson Cancer Center
Pneumoperitoneum Management With Low vs. Higher Pressure	NCT03128281	Malignant Neopl...	Questionnaires Conventional In... ConMed AirSeal ... ConMed AirSeal ...	18 Years - 80 Years	M.D. Anderson Cancer Center
Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients	NCT04281017	Intraocular Pre... Oncology	TIVA Balanced anesth...	18 Years - 99 Years	University of Florida
Effect of Position and Anesthetic Choice in Intraocular Pressure in Robotic GYN (Gynecologic) Oncology Patients	NCT04281017	Intraocular Pre... Oncology	TIVA Balanced anesth...	18 Years - 99 Years	University of Florida

Spots Global Cancer Trial Database for robotic gynecologic surgery