Deep Neuromuscular Blockade During Robotic Radical Prostatectomy

Sponsor

Palacky University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02513693

Collaborator

University Hospital Olomouc (Other), Masaryk Hospital Usti nad Labem (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Blockade	Drug: Standard neuromuscular blockade Drug: Deep neuromuscular blockade	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2016

Anticipated Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard Neuromuscular Blockade 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.	Drug: Standard neuromuscular blockade Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine. Other Names: Rocuronium + neostigmine
Experimental: Deep Neuromuscular Blockade 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.	Drug: Deep neuromuscular blockade Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex. Other Names: Rocuronium + sugammadex

Arm

Intervention/Treatment

Experimental: Standard Neuromuscular Blockade

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.

Drug: Standard neuromuscular blockade

Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.

Other Names:

Rocuronium + neostigmine

Experimental: Deep Neuromuscular Blockade

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.

Drug: Deep neuromuscular blockade

Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.

Other Names:

Rocuronium + sugammadex

Outcome Measures

Primary Outcome Measures

Surgical condition [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.

Secondary Outcome Measures

Quality of recovery [2 months]
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.
"Ready to leave operating room (OR)" time [Period of patient's presence at OR]
"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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc	Olomouc		Czech Republic	775 20
2	Dept. of Anesthesiology, Perioperative Medicine and Intensive Care, J. E. Purkinje University, Masaryk Hospital	Usti nad Labem		Czech Republic	401 13

Sponsors and Collaborators

Palacky University
University Hospital Olomouc
Masaryk Hospital Usti nad Labem

Investigators

Study Director: Milan Adamus, MD,PhD,MBA, Department of Anesthesiology and Intensive Care Medicine Palacky University Olomouc Faculty of Medicine and Dentistry
Principal Investigator: Vladimir Cerny, MD,PhD,FCCM, J. E. Purkinje University, Masaryk Hospital, Usti nad Labem, Czech Republic, Dept. of Anesthesiology, Perioperative Medicine and Intensive Care