Neuromuscular BlockadePhase 4NCT02513693
Deep Neuromuscular Blockade During Robotic Radical Prostatectomy
A Phase 4 study testing Standard neuromuscular blockade and Deep neuromuscular blockade in people with Neuromuscular Blockade, run by Palacky University at 2 sites in Czechia.
Trial summary
Basic requirement for safe performance of the robotic intra-abdominal surgery is a calm and clear surgical field after the introduction of a capnoperitoneum. That can be enabled by a neuromuscular blockade. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Standard neuromuscular blockade and Deep neuromuscular blockade
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesCzechia
- Study dates
- Jul 2015to Mar 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Informed consent
- Elective robotic radical prostatectomy
- American Society of Anesthesiologists (ASA) status 1-3
Who cannot join
- Age under 18 years
- American Society of Anesthesiologists (ASA) status over 3
- Indication for rapid sequence induction, signs of difficult airway severe neuromuscular, liver or renal disease
- Known allergy to drugs used in the study
- Malignant hyperthermia (medical history)
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc
Olomouc, 775 20
Milan Adamus, MD,PhD,MBA, +420 588 442 705, milan.adamus@seznam.cz
Lenka Doubravská, MD, +420 588 445 979, lenadoub@seznam.cz
- Recruiting
Dept. of Anesthesiology, Perioperative Medicine and Intensive Care, J. E. Purkinje University, Masaryk Hospital
Ústí nad Labem, 401 13
Vladimir Cerny, MD,PhD,FCCM, +420 602 492 054, cernyvla1960@gmail.com
About this study
Official title: Effect of Deep Neuromuscular Blockade on Surgical Conditions and Recovery After Robotic Radical Prostatectomy: a Prospective Randomized Study
Basic requirement for safe performance of the robotic intra-abdominal surgery is a calm and clear surgical field after the introduction of a capnoperitoneum. That can be enabled by a neuromuscular blockade. Provision of standard neuromuscular blockade is a compromise between optimal surgical conditions (sufficiently deep block) and capability to antagonize the block rapidly at the end of the surgery. With rocuronium, it is possible to maintain deep neuromuscular blockade safely until the very end of the surgery, and unlike with spontaneous recovery or reversal of the block with neostigmine, administration of sugammadex at the end of the surgery will enable quick and consistent reversal of the block. Project is focused on comparison of the parameters of deep and standard neuromuscular blockade - surgical conditions (primary endpoint), quality of recovery and turnover time (secondary endpoints).
Read the detailed description
Balanced anesthesia is an anesthetic procedure of choice for intra-abdominal surgery. Main components of this procedure are loss of consciousness, treatment of pain and appropriate neuromuscular blockade (NMB). Peripheral neuromuscular blocking agents (NMBA) are drugs used for muscle relaxation during balanced anesthesia. Their use plays essential role for tracheal intubation, orotracheal tube tolerance, introduction of mechanical ventilation and provision of calm surgical field.
In laparoscopic procedures, introduction of capnoperitoneum for good visibility in surgical field is necessary. From anesthetic point of view this requirement can be met by adequate muscle relaxation. After withdrawal of capnoperitoneum at the end of the surgery the procedure is usually terminated quickly (this phase consists only from suture of a peritoneum and the small incisions through which instruments were inserted). Spontaneous recovery from NMB or usual reversal of the block by neostigmine are not fast and reliable enough at this moment. During standard neuromuscular blockade the dosage of NMBA is a compromise between optimal surgical conditions (sufficiently deep block) and capability to antagonize the block rapidly at the end of the surgery. Introduction of sugammadex into clinical praxis brings the potential to change this paradigm. With rocuronium, it is possible to maintain deep neuromuscular blockade safely until the very end of the surgery and unlike with spontaneous recovery or reversal of the block with neostigmine, administration of sugammadex at the end of the surgery will enable quick and consistent reversal of the block. Data about routine use of the deep block are rare, PubMed lists with search strategy [(deep neuromuscular blockade) AND (laparoscopic surgery OR laparoscopy)] 11 references (January 12, 2015, www.pubmed.com).
Patients undergoing robotic radical prostatectomy will be randomized to two groups differing in muscle relaxation strategy (standard vs. deep) and the type of antagonizing drug at the end of the surgery (neostigmine vs. sugammadex). Relevant end-points and the differences between groups with deep and standard neuromuscular blockade will be compared. Indication and dosage of rocuronium, neostigmine and sugammadex correspond to manufacturers' recommendations.
- Conditions
- Neuromuscular Blockade
- Being tested
- Standard neuromuscular blockade, Deep neuromuscular blockade
- Keywords
- Anesthesia, Rocuronium, Sugammadex, Neostigmine, TOF, Radical Prostatectomy, Robotic Surgery, Accelerometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard neuromuscular blockadeDrug
Also called Rocuronium + neostigmine
Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.
Deep neuromuscular blockadeDrug
Also called Rocuronium + sugammadex
Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.
| Study group | Role | What they receive |
|---|---|---|
| Standard Neuromuscular Blockade | Experimental | Drug: rocuronium + neostigmine
Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Train-of-Four (TOF) count = 1-2, TOF-count measurement every 1 min. Neuromuscular blockade reversal at the end of anesthesia: neostigmine 0.03 mg/kg iv + atropine 0.5-1.0 mg iv Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1.5-2.5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv Extubation when patient is conscious and attained the recovery from neuromuscular blockade to a TOF-ratio of at least 0,9. Receives: Drug: Standard neuromuscular blockade |
| Deep Neuromuscular Blockade | Experimental | Drug: rocuronium + sugammadex
Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Post-tetanic Count (PTC) = 1-2; PTC measurement every 4 min. Neuromuscular blockade reversal at the end of anesthesia: sugammadex 2 mg/kg iv (when PTC is 18-20 and TOF-count 0) or sugammadex 4 mg/kg iv (when PTC under 18).
Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1,5-2,5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv.
Extubation when patient is conscious and attained recovery from neuromuscular blockade to a TOF-ratio of at least 0,9. Receives: Drug: Deep neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical condition
Surgical rating score (SRS) - surgical condition will be evaluated by surgeon every 15 minutes on predefined five point scale (excellent - above average - average - below average - poor). For each patient, the final score will be the average of all 15 min SRS values.
Measured: Every 15 minutes during surgery until final suture
Secondary outcomes (2)
Quality of recovery
Speed of clinical recovery by using Post-Operative Quality Recovery Scale (www.pqrsonline.org). PQRS will be evaluated at following time points:
preoperatively, day (D) 1, D3, D7, month (M) 1, M2.
Measured: 2 months
"Ready to leave operating room (OR)" time
"Ready to leave OR time" will be defined as a time period (in minutes) from the time point of completing surgery to the time point, when patient is ready to leave OR to the facility providing postanesthesia care.
Measured: Period of patient's presence at OR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palacky University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Olomouc, Masaryk Hospital Usti nad Labem
- Responsible party
- Principal investigator, Milan Adamus, MD, PhD, MBA, Palacky University
- Investigators
- Milan Adamus, MD,PhD,MBA, Study director, Department of Anesthesiology and Intensive Care Medicine Palacky University Olomouc Faculty of Medicine and DentistryVladimir Cerny, MD,PhD,FCCM, Principal investigator, J. E. Purkinje University, Masaryk Hospital, Usti nad Labem, Czech Republic, Dept. of Anesthesiology, Perioperative Medicine and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513693
- Sponsor's protocol ID
- IGA_LF_2015_012
- Status last verified
- Jul 2015
- First submitted
- 28 Jul 2015
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindekaer AL, Halvor Springborg H, Istre O. Deep neuromuscular blockade leads to a larger intraabdominal volume during laparoscopy. J Vis Exp. 2013 Jun 25;(76):50045. doi: 10.3791/50045.
PubMed 23851450Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gatke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579.
PubMed 23461992Boon M, Martini CH, Aarts LP, Bevers RF, Dahan A. Effect of variations in depth of neuromuscular blockade on rating of surgical conditions by surgeon and anesthesiologist in patients undergoing laparoscopic renal or prostatic surgery (BLISS trial): study protocol for a randomized controlled trial. Trials. 2013 Mar 1;14:63. doi: 10.1186/1745-6215-14-63.
PubMed 23452344Ding L, Zhang H, Mi W, Sun L, Zhang X, Ma X, Li H. [Effects of carbon dioxide pneumoperitoneum and steep Trendelenburg positioning on cerebral blood backflow during robotic radical prostatectomy]. Nan Fang Yi Ke Da Xue Xue Bao. 2015 May;35(5):712-5. Chinese.
PubMed 26018268Ding L, Zhang H, Mi W, He Y, Zhang X, Ma X, Li H. [Effects of dexmedetomidine on recovery period of anesthesia and postoperative cognitive function after robot-assisted laparoscopicradical prostatectomy in the elderly people]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2015 Feb;40(2):129-35. doi: 10.11817/j.issn.1672-7347.2015.02.003. Chinese.
PubMed 25769330Dogra PN, Saini AK, Singh P, Bora G, Nayak B. Extraperitoneal robot-assisted laparoscopic radical prostatectomy: Initial experience. Urol Ann. 2014 Apr;6(2):130-4. doi: 10.4103/0974-7796.130555.
PubMed 24833824Kopman AF, Naguib M. Laparoscopic surgery and muscle relaxants: is deep block helpful? Anesth Analg. 2015 Jan;120(1):51-58. doi: 10.1213/ANE.0000000000000471.
PubMed 25625254Donati F, Brull SJ. More muscle relaxation does not necessarily mean better surgeons or "the problem of muscle relaxation in surgery". Anesth Analg. 2014 Nov;119(5):1019-21. doi: 10.1213/ANE.0000000000000429. No abstract available.
PubMed 25329018Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
PubMed 24240315Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gatke MR. Surgical space conditions during low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular blockade: a randomized clinical study. Anesth Analg. 2014 Nov;119(5):1084-92. doi: 10.1213/ANE.0000000000000316.
PubMed 24977638Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.
PubMed 24809482Vijayaraghavan N, Sistla SC, Kundra P, Ananthanarayan PH, Karthikeyan VS, Ali SM, Sasi SP, Vikram K. Comparison of standard-pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy: a double blinded randomized controlled study. Surg Laparosc Endosc Percutan Tech. 2014 Apr;24(2):127-33. doi: 10.1097/SLE.0b013e3182937980.
PubMed 24686347Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.
PubMed 24639018Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
PubMed 20601860
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Neuromuscular Blockade on Surgical Conditions and Recovery After Robotic Radical Prostatectomy: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT02513693
- Acronym / sponsor ID
- IGA_LF_2015_012
- Conditions
- Neuromuscular Blockade
- Keywords
- Anesthesia, Rocuronium, Sugammadex, Neostigmine, TOF, Radical Prostatectomy, Robotic Surgery, Accelerometry
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Palacky UniversityUniversity, hospital or other
- Collaborators
- University Hospital Olomouc, Masaryk Hospital Usti nad Labem
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 3 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Basic requirement for safe performance of the robotic intra-abdominal surgery is a calm and clear surgical field after the introduction of a capnoperitoneum. That can be enabled by a neuromuscular blockade. Provision of standard neuromuscular blockade is a compromise between optimal surgical conditions (sufficiently deep block) and capability to antagonize the block rapidly at the end of the surgery. With rocuronium, it is possible to maintain deep neuromuscular blockade safely until the very end of the surgery, and unlike with spontaneous recovery or reversal of the block with neostigmine, administration of sugammadex at the end of the surgery will enable quick and consistent reversal of the block. Project is focused on comparison of the parameters of deep and standard neuromuscular blockade - surgical conditions (primary endpoint), quality of recovery and turnover time (secondary endpoints).
Detailed description
Balanced anesthesia is an anesthetic procedure of choice for intra-abdominal surgery. Main components of this procedure are loss of consciousness, treatment of pain and appropriate neuromuscular blockade (NMB). Peripheral neuromuscular blocking agents (NMBA) are drugs used for muscle relaxation during balanced anesthesia. Their use plays essential role for tracheal intubation, orotracheal tube tolerance, introduction of mechanical ventilation and provision of calm surgical field.
In laparoscopic procedures, introduction of capnoperitoneum for good visibility in surgical field is necessary. From anesthetic point of view this requirement can be met by adequate muscle relaxation. After withdrawal of capnoperitoneum at the end of the surgery the procedure is usually terminated quickly (this phase consists only from suture of a peritoneum and the small incisions through which instruments were inserted). Spontaneous recovery from NMB or usual reversal of the block by neostigmine are not fast and reliable enough at this moment. During standard neuromuscular blockade the dosage of NMBA is a compromise between optimal surgical conditions (sufficiently deep block) and capability to antagonize the block rapidly at the end of the surgery. Introduction of sugammadex into clinical praxis brings the potential to change this paradigm. With rocuronium, it is possible to maintain deep neuromuscular blockade safely until the very end of the surgery and unlike with spontaneous recovery or reversal of the block with neostigmine, administration of sugammadex at the end of the surgery will enable quick and consistent reversal of the block. Data about routine use of the deep block are rare, PubMed lists with search strategy [(deep neuromuscular blockade) AND (laparoscopic surgery OR laparoscopy)] 11 references (January 12, 2015, www.pubmed.com).
Patients undergoing robotic radical prostatectomy will be randomized to two groups differing in muscle relaxation strategy (standard vs. deep) and the type of antagonizing drug at the end of the surgery (neostigmine vs. sugammadex). Relevant end-points and the differences between groups with deep and standard neuromuscular blockade will be compared. Indication and dosage of rocuronium, neostigmine and sugammadex correspond to manufacturers' recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Neuromuscular Blockade | Experimental | Drug: Standard neuromuscular blockadeDrug: rocuronium + neostigmine Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Train-of-Four (TOF) count = 1-2, TOF-count measurement every 1 min. Neuromuscular blockade reversal at the end of anesthesia: neostigmine 0.03 mg/kg iv + atropine 0.5-1.0 mg iv Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1.5-2.5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv Extubation when patient is conscious and attained the recovery from neuromuscular blockade to a TOF-ratio of at least 0,9. |
| Deep Neuromuscular Blockade | Experimental | Drug: Deep neuromuscular blockadeDrug: rocuronium + sugammadex Administration of rocuronium 0,6 mg/kg iv, top-ups 5-10 mg iv to target value of Post-tetanic Count (PTC) = 1-2; PTC measurement every 4 min. Neuromuscular blockade reversal at the end of anesthesia: sugammadex 2 mg/kg iv (when PTC is 18-20 and TOF-count 0) or sugammadex 4 mg/kg iv (when PTC under 18). Induction of anesthesia: midazolam 1-2 mg iv, sufentanil 10-30 mcg iv, propofol 1,5-2,5 mg/kg iv Anesthesia: sevoflurane in air to target 1.2-1.5 minimal alveolar concentration (MAC). Rescue medication: sevoflurane, propofol 20-40 mg iv. Extubation when patient is conscious and attained recovery from neuromuscular blockade to a TOF-ratio of at least 0,9. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- Informed consent
- Elective robotic radical prostatectomy
- American Society of Anesthesiologists (ASA) status 1-3
Key exclusion criteria (5 listed)
- Age under 18 years
- American Society of Anesthesiologists (ASA) status over 3
- Indication for rapid sequence induction, signs of difficult airway severe neuromuscular, liver or renal disease
- Known allergy to drugs used in the study
- Malignant hyperthermia (medical history)
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 |
|---|---|---|
| Standard neuromuscular blockadeAlso: Rocuronium + neostigmineStandard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine. | Drug | Standard Neuromuscular Blockade |
| Deep neuromuscular blockadeAlso: Rocuronium + sugammadexDeep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex. | Drug | Deep Neuromuscular Blockade |
Primary outcome
Surgical condition
Time frame: Every 15 minutes during surgery until final suture
Surgical rating score (SRS) - surgical condition will be evaluated by surgeon every 15 minutes on predefined five point scale (excellent - above average - average - below average - poor). For each patient, the final score will be the average of all 15 min SRS values.
2 secondary outcomes
Quality of recovery
Time frame: 2 months
"Ready to leave operating room (OR)" time
Time frame: Period of patient's presence at OR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
- Results publication: PubMed 23851450Lindekaer AL, Halvor Springborg H, Istre O. Deep neuromuscular blockade leads to a larger intraabdominal volume during laparoscopy. J Vis Exp. 2013 Jun 25;(76):50045. doi: 10.3791/50045.
- Results publication: PubMed 23461992Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gatke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579.
- Results publication: PubMed 23452344Boon M, Martini CH, Aarts LP, Bevers RF, Dahan A. Effect of variations in depth of neuromuscular blockade on rating of surgical conditions by surgeon and anesthesiologist in patients undergoing laparoscopic renal or prostatic surgery (BLISS trial): study protocol for a randomized controlled trial. Trials. 2013 Mar 1;14:63. doi: 10.1186/1745-6215-14-63.
- Results publication: PubMed 26018268Ding L, Zhang H, Mi W, Sun L, Zhang X, Ma X, Li H. [Effects of carbon dioxide pneumoperitoneum and steep Trendelenburg positioning on cerebral blood backflow during robotic radical prostatectomy]. Nan Fang Yi Ke Da Xue Xue Bao. 2015 May;35(5):712-5. Chinese.
- Results publication: PubMed 25769330Ding L, Zhang H, Mi W, He Y, Zhang X, Ma X, Li H. [Effects of dexmedetomidine on recovery period of anesthesia and postoperative cognitive function after robot-assisted laparoscopicradical prostatectomy in the elderly people]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2015 Feb;40(2):129-35. doi: 10.11817/j.issn.1672-7347.2015.02.003. Chinese.
- Results publication: PubMed 24833824Dogra PN, Saini AK, Singh P, Bora G, Nayak B. Extraperitoneal robot-assisted laparoscopic radical prostatectomy: Initial experience. Urol Ann. 2014 Apr;6(2):130-4. doi: 10.4103/0974-7796.130555.
- Results publication: PubMed 25625254Kopman AF, Naguib M. Laparoscopic surgery and muscle relaxants: is deep block helpful? Anesth Analg. 2015 Jan;120(1):51-58. doi: 10.1213/ANE.0000000000000471.
- Results publication: PubMed 25329018Donati F, Brull SJ. More muscle relaxation does not necessarily mean better surgeons or "the problem of muscle relaxation in surgery". Anesth Analg. 2014 Nov;119(5):1019-21. doi: 10.1213/ANE.0000000000000429. No abstract available.
- Results publication: PubMed 24240315Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
- Results publication: PubMed 24977638Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gatke MR. Surgical space conditions during low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular blockade: a randomized clinical study. Anesth Analg. 2014 Nov;119(5):1084-92. doi: 10.1213/ANE.0000000000000316.
- Results publication: PubMed 24809482Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.
- Results publication: PubMed 24686347Vijayaraghavan N, Sistla SC, Kundra P, Ananthanarayan PH, Karthikeyan VS, Ali SM, Sasi SP, Vikram K. Comparison of standard-pressure and low-pressure pneumoperitoneum in laparoscopic cholecystectomy: a double blinded randomized controlled study. Surg Laparosc Endosc Percutan Tech. 2014 Apr;24(2):127-33. doi: 10.1097/SLE.0b013e3182937980.
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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.
Milan Adamus, MD,PhD,MBA study director
Department of Anesthesiology and Intensive Care Medicine Palacky University Olomouc Faculty of Medicine and Dentistry
Vladimir Cerny, MD,PhD,FCCM principal investigator
J. E. Purkinje University, Masaryk Hospital, Usti nad Labem, Czech Republic, Dept. of Anesthesiology, Perioperative Medicine and Intensive Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard neuromuscular blockade and Deep neuromuscular blockade in people with Neuromuscular Blockade, run by Palacky University at 2 sites in Czechia.
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 5 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: status not confirmed, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milan Adamus, MD,PhD,MBA (+420588442705, milan.adamus@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical condition (time frame: Every 15 minutes during surgery until final suture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02513693, which also lists 14 linked publications.
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 3 Aug 2015.