Urologic Diseases Clinical Trial
— NMBOfficial title:
Does Depth of Neuromuscular Blockade (NMB) Affect Surgical Conditions and Postoperative Pain in Obese Patients Undergoing Robotic Surgery
NCT number | NCT03591289 |
Other study ID # | 17.1119 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | February 2018 |
Est. completion date | July 12, 2018 |
Verified date | April 2021 |
Source | University of Louisville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A prospective, randomized, outcome trial to evaluate, if depth of neuromuscular blockade (NMB) will affect surgical conditions and postoperative pain based on the degree of neuromuscular block during robotic surgery for gynecological and urologic procedures in obese and non-obese patients.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 12, 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients scheduled for elective robotic gynecological or urologic surgery under general anesthesia. 2. Patients are willing and sign an IRB approved consent 3. Patients will be 18 years or older Exclusion Criteria: 1. Patients with atrial fibrillation 2. Other significant arrhythmia (Lown grade 3 or greater) 3. Patients with aortic regurgitation 4. Unable to receive or refuses to usehydromorphone for pain management post-operatively (allergic, bad experience previously with use) |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville Medical School, Department of Anesthesiology and Perioperative Medicine | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Rainer Lenhardt |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of surgical conditions during deep versus moderate NMB in patients undergoing robotic abdominal surgery | Surgical conditions will be assessed by the Leiden surgical rating scale (Martini BJA 2014; 112:498) as follows:
Scale range from 1 to 5 with 1 describing extremely poor conditions and 5 describing optimal conditions for surgery |
data will be reported every 15 minutes starting post anesthesia induction until the end of general anesthesia | |
Secondary | Assessment of PVI changes to predict fluid responsiveness in robotic surgery | PVI changes will be measured after each fluid challenge and correlated with a change in stroke volume | PVI will be measured every 15 minutes and after any fluid bolus. Fluid bolus will be given, when PVI is > 12 | |
Secondary | Incidence of good and optimal surgical conditions in obese and non-obese patients undergoing robotic abdominal surgery | Surgical conditions will be assessed by the Leiden surgical rating scale and will be compared in obese patients versus non-obese patients
Surgical conditions will be assessed by the Leiden surgical rating scale (Martini BJA 2014; 112:498) as follows: Scale range from 1 to 5 with 1 describing extremely poor conditions and 5 describing optimal conditions for surgery |
Data will be reported every 15 minutes starting post anesthesia induction until the end of general anesthesia | |
Secondary | Assessment of postoperative pain after deep versus moderate NMB in patients undergoing robotic abdominal surgery. Does depth of neuromuscular block (NMB) affect postoperative pain ? | Postoperative pain will be measured by visual pain analogue scale and by the amount of hydromorphone used in 24 hours after surgery.
Pain assessments will be completed using the "visual pain analogue scale" (VAS). VAS scale ranges from 1 to 100 mm, with 1 meaning no pain at all to 100 rated as the worst pain imaginable |
First 24 hours postoperatively at time points 1hour, 6 hours after surgery and postoperative day one |
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