Surgical Conditions Clinical Trial
— BLISS4Official title:
Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions in Patients Undergoing Laparoscopic Renal Surgery
NCT number | NCT03170661 |
Other study ID # | p17.049 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 14, 2017 |
Est. completion date | June 1, 2020 |
Verified date | April 2021 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A deep neuromuscular block (NMB) is often associated with improved surgical conditions especially in laparoscopic surgery. We previously showed that deep NMB is superior to a moderate NMB under propofol anesthesia. However, this may not apply to sevoflurane anesthesia and sevoflurane by itself produces some degree of muscle relaxation. We therefore plan to investigate the effect of deep NMB on surgical conditions under sevoflurane anesthesia maintenance.
Status | Completed |
Enrollment | 98 |
Est. completion date | June 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy; - American Society of Anesthesiologists (ASA) class I-III - > 18 years of age; - Ability to give oral and written informed consent. Exclusion Criteria: - Known or suspected neuromuscular disorders impairing neuromuscular function; - Allergies to muscle relaxants, anesthetics or narcotics; - A (family) history of malignant hyperthermia; - Women who are or may be pregnant or are currently breast feeding; - Renal insufficiency, as defined by glomerular filtration rate < 30 ml/h creatinine. - Previous retroperitoneal surgery at the site of the current surgery. - Body mass index > 35 kg/m2 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | Merck Sharp & Dohme Corp. |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Leiden Surgical Rating Scale | During the on average 3 hour procedure, the surgical condition will be scored by the surgeon using a 5-point surgical rating scale at 15 minute intervals(1: poor ; 5: optimal) Mean and standard deviation of the average of all leiden surgical rating scale will be reported. | during surgery | |
Secondary | Postoperative Measurements and Outcomes; Pain Scores | Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period
-mean pain scores (numeric rating scale; 0 no pain - 10 worst pain imaginable) |
During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals | |
Secondary | Intraoperative Hemodynamic Conditions | Perioperative average blood pressure will be reported, mean blood pressure ranging from 65 tot 110 millimeters mercury is considered normal | Perioperative measurements at 15 minute interval (on average during 3 hours) | |
Secondary | Postoperative Measurements and Outcomes; Sedation Levels | Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period
-ramsay sedation levels (0 = normal alertness, eyes open, responds normal to command 1 = drowsy with open eyes, closed and opened on command 2 = drowsy with closed eyes, opened in response to light auditory stimulus 3 = eyes closed, opened in response to rubbing the shoulder or a loud auditory stimulus 4 = eyes closed and opened only briefly in response to touching the subject 5 = eyes closed, unarousable by touch, aroused by painful 6 = unarousable by pain) |
During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals | |
Secondary | Postoperative Measurements and Outcomes; Saturation | Postoperative measurements and outcomes of during PACU stay, all scores are reported as means and standard deviation of the average over the follow up period
-blood oxygen saturation in percent levels between 95-100 are considered normal |
During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals | |
Secondary | Intraoperative Nociception Level | The median and full range of the average nociception level index will be reported.
The nociception level index consist of Ta multiparameter nonlinear combination of heart rate, heart rate variability, amplitude of the finger photoplethysmogram, skin conductance level, fluctuations in skin conductance, and their time derivatives, derived from random forest regression. Random forest is an algorithmic modeling approach that enables combining multiple parameters of different origin and discovering their complex nonlinear interactions. Normal range is between 10-20; 0 indicates no nociceptive events (in example, pain stimuli), 100 indicates severe painful stimuli. |
Perioperative measurements at 15 minute interval (on average during 3 hours) |
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