Deep Neuromuscular Blockade During Robotic Radical Prostatectomy

Neuromuscular Blockade Clinical Trial

Official title:

Effect of Deep Neuromuscular Blockade on Surgical Conditions and Recovery After Robotic Radical Prostatectomy: a Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02513693
• Other study ID #: IGA_LF_2015_012
• Status: Recruiting
• Phase: Phase 4
• First received: July 28, 2015
• Last updated: July 30, 2015
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2015
• Source: Palacky University
• Contact: Milan Adamus, MD,PhD,MBA
• Phone: +420588442705
• Email: milan.adamus[@]seznam.cz
• Is FDA regulated: No
• Health authority: Czech Republic: Ministry of Health
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years

• Informed consent

• Elective robotic radical prostatectomy

• American Society of Anesthesiologists (ASA) status 1-3

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Standard neuromuscular blockade
Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.
• Deep neuromuscular blockade
Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.

Locations

Country	Name	City	State
Czech Republic	Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc	Olomouc
Czech Republic	Dept. of Anesthesiology, Perioperative Medicine and Intensive Care, J. E. Purkinje University, Masaryk Hospital	Usti nad Labem

Sponsors (3)

Lead Sponsor	Collaborator
Palacky University	Masaryk Hospital, Usti nad Labem, University Hospital Olomouc

Country where clinical trial is conducted

Czech Republic, 

References & Publications (14)

Boon 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 — View Citation

Ding 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 — View Citation

Ding 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. Chine — View Citation

Dogra 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. — View Citation

Donati 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. — View Citation

Dubois 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.000000000000009 — View Citation

Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;3:CD006930. doi: 10.1002/14651858.CD006930.pub3. Review. — View Citation

Kopman AF, Naguib M. Laparoscopic surgery and muscle relaxants: is deep block helpful? Anesth Analg. 2015 Jan;120(1):51-8. doi: 10.1213/ANE.0000000000000471. Review. — View Citation

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). doi: 10.3791/50045. — View Citation

Martini 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. — View Citation

Royse 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; — View Citation

Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gätke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579. — View Citation

Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Lindekaer AL, Riber C, Gätke MR. Surgical space conditions during low-pressure laparoscopic cholecystectomy with deep versus moderate neuromuscular blockade: a randomized clinical study. Anesth Analg. 2014 — View Citation

Vijayaraghavan 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 Lapa — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every 15 minutes during surgery until final suture	No
Secondary	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.	2 months	No
Secondary	"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.	Period of patient's presence at OR	No