Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

•Subjects who undergo steep Trendelenburg will remain in 30 degrees of Trendelenburg, and the da Vinci robot will be docked.

After subjects are asleep an arterial line will be place in one wrist by the anesthesiologist. It will be removed at the conclusion of the procedure.

Steep Trendelenburg

•Subjects who undergo decreased Trendelenburg will be taken out of Trendelenburg to the minimal angle possible that enables adequate visualization, as determined by the primary surgeon, at which time robot will be docked.

After subjects are asleep an arterial line will be place in one wrist by the anesthesiologist. It will be removed at the conclusion of the procedure.

Decreased Trendelenburg

Kirsten Sasaki, MD

Patient/Population: Women over the age of 18, who are not pregnant and are undergoing benign, robotic-assisted gynecologic procedures at Lutheran General Hospital.

Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep Trendelenburg, which is the usual standard of care, to the limit of the operative bed, which is 30 degrees.

Outcome: Outcomes will include the mean angle of Trendelenburg in the experimental arm and the difference in Trendelenburg between the two arms. Additional outcomes included will be end tidal Carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and arterial Carbon dioxide. Secondary outcomes will include operative time, blood loss and conversion to laparotomy.

For any patient undergoing robotic-assisted benign laparoscopic procedures at Lutheran General Hospital were eligible to participate. Each subject was randomized to steep or a decreased angle of Trendelenburg. While under anesthesia an arterial line would be placed to monitor vital signs. At specific time points throughout surgery, all vital signs were measured including End Tidal CO2, peak airway pressure, mean arterial pressure, heart rate and arterial CO2 as well as operative time, blood loss and conversion to laparotomy.

The arterial line was removed at the conclusion of the case, and all variables will be compared between the two cohorts.

Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?

Measured using electronic Angle Meter from supine to Trendelenburg in degrees (0-30)

Heart rate (beats per minute) measured in beats per minute by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and at the end of the case.

Arterial CO2- Measured by taking an arterial blood gas from the arterial line by the anesthesiologist at the beginning of the case prior to insufflation, and then every hour while in Trendelenburg.

End Tidal CO2 measured in mmHg by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and then at the end of the case.

Peak Airway Pressure (mm Hg) measured in mmHg by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and then at the end of the case.

Mean arterial pressure (mm hg) measured in mmHg by anesthesiologist at the beginning of the case prior to insufflation, after insufflation, every 30 minutes while in Trendelenburg and then at the end of the case.

The operative time will be measured (minutes) from the time the robot was docked until it is undocked.

The blood loss (mL) will be measured by subtracting the irrigation fluid used from the fluid suctioned out during the procedure.

It will be recorded whether the robot required undocking, placement in greater Trendelenburg and redocking of the robot in order to complete the procedure.

It will be recorded whether the surgical approach was transitioned to traditional laparoscopy or laparotomy versus a robotic-assisted procedure as scheduled.

Advocate Health Care

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anti-Inflammatory Agents

Antirheumatic Agents

Ropivacaine

Morphine

Parecoxib

Cyclooxygenase Inhibitors

Cyclooxygenase 2 Inhibitors

Enzyme Inhibitors

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Before incision, patients in controlled Group received NS

Before incision, parecoxib patients received 40mg of parecoxib IV

Before incision, patients in Group P (n = 120) receive 40mg of parecoxib IV. Thereafter, parecoxib patients receive 40mg of parecoxib IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.

Parecoxib Sodium

Before incision, patients in Group C (n = 120) receive 2 mL of normal saline IV. Thereafter, they receive 2 mL of normal saline IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.

Normal saline

Wenqi Huang, postgraduate

The purpose of this study is to determine the effects of parecoxib in combination with epidural morphine in providing analgesia for patients undergoing gynecological surgery.

Researches have showed that the use of epidural and spinal block resulted in significant reduction in morbidity and mortality after surgery. Moreover, appropriate pain management results in better outcomes. Opioids therapy is recommended as the first choice medication for the management of postoperative pain but is associated with a number of undesirable adverse effects. A multimodal therapy for providing postoperative analgesia has advantages over the use of opioids alone. The use of NSAIDs and opioids together often improves analgesia and reduces the need for opioids in the postoperative period. Often, the combination of COX-2 inhibitors with epidural analgesia is preferred. With epidural analgesia, addition of COX-2 inhibitors may improve the analgesia and decrease the undesirable side effects.

Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery

A Multicenter, Randomised, Double-blinded, Placebo-controlled Trial Comparing the Efficacy and Safety of Intravenous Parecoxib Sodium on Morphine Patient-controlled Epidural Analgesia After Gynecologic Surgery

The primary end-point of this study was to quantify the morphine-sparing effect of a multimodal approach containing parecoxib compared with the standard PCEA approach in patients undergoing abdominal hysterectomy.

The secondary outcome included pain intensity, the patients' global evaluation, and side effects accompanied with PCEA and parecoxib, such as nausea, vomiting, pruritus, sedation, motor block in the lower extremities, and the time to passage of flatus and first bowel movement.Blood loss, length of hospitalization, and postoperative cardiovascular (CV) events were also recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?	NCT02728999	Benign Female R...	Steep Trendelen... Decreased Trend...	18 Years -	Advocate Health Care
Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery	NCT01566669	Benign Female R...	Parecoxib Sodiu... Normal saline	18 Years - 65 Years	First Affiliated Hospital, Sun Yat-Sen University
Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery	NCT01566669	Benign Female R...	Parecoxib Sodiu... Normal saline	18 Years - 65 Years	First Affiliated Hospital, Sun Yat-Sen University

Spots Global Cancer Trial Database for benign female reproductive system neoplasm