Surgical ConditionsPhase 4BLISS4NCT03170661
Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions.
A Phase 4 study testing Deep neuromuscular block in people with Surgical Conditions, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Conditions
- What is being tested?
- Deep neuromuscular block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jun 2017to 1 Jun 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions in Patients Undergoing Laparoscopic Renal Surgery
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.
Read the detailed description
Neuromuscular blocking agents (NMBAs) are routinely administered during general anaesthesia to facilitate endotracheal intubation and to optimize surgical conditions. Increasing data suggest superiority of a deep neuromuscular block (defined by a post-tetanic count of 1-2 twitches) in creating optimal working conditions for the surgical team. However, it is unknown whether other aspects of the anaesthetic technique, most notably the choice of anaesthetic (for example, total intravenous versus inhalational anaesthesia), influence the relationship between the depth of the neuromuscular block and surgical conditions, particularly in laparoscopic surgery. Volatile anaesthetics are known for their ability to potentiate neuromuscular blocking agents an effect that is less existent with propofol. We previously showed that surgical working conditions in laparoscopic surgery during propofol anaesthesia are highly reliant on the depth of the neuromuscular block. Whether such a relationship also exists for inhalational anaesthetics, is unknown. To investigate this, we conducted a prospective, randomized, double blind study in which patients scheduled for laparoscopic renal surgery were randomized to receive either a moderate or a deep neuromuscular block during sevoflurane anaesthesia. The primary outcome was the intraoperative surgical condition assessed by a surgeon using the validated Leiden-Surgical Rating Scale. We hypothesized that the use of an inhalational anaesthetic would obviate the need for a deep NMB due to its intrinsic muscle relaxant potentiating properties to produce optimal working conditions.
- Conditions
- Surgical Conditions
- Being tested
- Deep neuromuscular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep neuromuscular blockDrug
Also called high dose rocuronium
Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
| Study group | Role | What they receive |
|---|---|---|
| Moderate neuromuscular block | No intervention | Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four |
| Deep neuromuscular block | Experimental | Subjects will receive deep neuromuscular block, aimed at 1-2 twitches post tetanic count Receives: Drug: Deep neuromuscular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during surgery
Secondary outcomes (5)
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)
Measured: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals
Intraoperative Hemodynamic Conditions
Perioperative average blood pressure will be reported, mean blood pressure ranging from 65 tot 110 millimeters mercury is considered normal
Measured: Perioperative measurements at 15 minute interval (on average during 3 hours)
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)
Measured: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals
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
Measured: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals
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.
Measured: Perioperative measurements at 15 minute interval (on average during 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start14 Jun 2017
- Primary completion1 Apr 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical ConditionsStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Albert Dahan, Leiden University Medical Center
- Investigators
- Albert Dahan, MD PhD, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170661
- Sponsor's protocol ID
- p17.049
- Acronym
- BLISS4
- Status last verified
- Apr 2021
- First submitted
- 25 Apr 2017
- Last updated
- 13 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Versus Moderate Neuromuscular Block During Sevoflurane Anesthesia on Intraoperative Surgical Conditions in Patients Undergoing Laparoscopic Renal Surgery
- ClinicalTrials.gov ID
- NCT03170661
- Acronym / sponsor ID
- BLISS4 / p17.049
- Conditions
- Surgical Conditions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neuromuscular blocking agents (NMBAs) are routinely administered during general anaesthesia to facilitate endotracheal intubation and to optimize surgical conditions. Increasing data suggest superiority of a deep neuromuscular block (defined by a post-tetanic count of 1-2 twitches) in creating optimal working conditions for the surgical team. However, it is unknown whether other aspects of the anaesthetic technique, most notably the choice of anaesthetic (for example, total intravenous versus inhalational anaesthesia), influence the relationship between the depth of the neuromuscular block and surgical conditions, particularly in laparoscopic surgery. Volatile anaesthetics are known for their ability to potentiate neuromuscular blocking agents an effect that is less existent with propofol. We previously showed that surgical working conditions in laparoscopic surgery during propofol anaesthesia are highly reliant on the depth of the neuromuscular block. Whether such a relationship also exists for inhalational anaesthetics, is unknown. To investigate this, we conducted a prospective, randomized, double blind study in which patients scheduled for laparoscopic renal surgery were randomized to receive either a moderate or a deep neuromuscular block during sevoflurane anaesthesia. The primary outcome was the intraoperative surgical condition assessed by a surgeon using the validated Leiden-Surgical Rating Scale. We hypothesized that the use of an inhalational anaesthetic would obviate the need for a deep NMB due to its intrinsic muscle relaxant potentiating properties to produce optimal working conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate neuromuscular block | No intervention | –Subjects will receive moderate neuromuscular block, aimed at 1-2 twitches train of four |
| Deep neuromuscular block | Experimental | Drug: Deep neuromuscular blockSubjects will receive deep neuromuscular block, aimed at 1-2 twitches post tetanic count |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep neuromuscular blockAlso: high dose rocuroniumDeep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count | Drug | Deep neuromuscular block |
Primary outcome
Leiden Surgical Rating Scale
Time frame: during surgery
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.
5 secondary outcomes
Postoperative Measurements and Outcomes; Pain Scores
Time frame: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals
Intraoperative Hemodynamic Conditions
Time frame: Perioperative measurements at 15 minute interval (on average during 3 hours)
Postoperative Measurements and Outcomes; Sedation Levels
Time frame: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals
Postoperative Measurements and Outcomes; Saturation
Time frame: During post-anesthetic care unit stay (average stay 2 hours) at 15 minute intervals
Intraoperative Nociception Level
Time frame: Perioperative measurements at 15 minute interval (on average during 3 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Dahan, MD PhD principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Deep neuromuscular block in people with Surgical Conditions, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leiden Surgical Rating Scale (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.