DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Deep Neuromuscular Blockade During Robotic Radical Prostatectomy

Information source: Palacky University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuromuscular Blockade

Intervention: Standard neuromuscular blockade (Drug); Deep neuromuscular blockade (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Palacky University

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

Overall contact:
Milan Adamus, MD,PhD,MBA, Phone: +420588442705, Email: milan.adamus@seznam.cz

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).

Clinical Details

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

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

Primary outcome: Surgical condition

Secondary outcome:

Quality of recovery

"Ready to leave operating room (OR)" time

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.

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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)

Locations and Contacts

Milan Adamus, MD,PhD,MBA, Phone: +420588442705, Email: milan.adamus@seznam.cz

Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Olomouc, Olomouc 775 20, Czech Republic; Recruiting
Milan Adamus, MD,PhD,MBA, Phone: +420 588 442 705, Email: milan.adamus@seznam.cz
Lenka Doubravsk√°, MD, Phone: +420 588 445 979, Email: lenadoub@seznam.cz

Dept. of Anesthesiology, Perioperative Medicine and Intensive Care, J. E. Purkinje University, Masaryk Hospital, Usti nad Labem 401 13, Czech Republic; Recruiting
Vladimir Cerny, MD,PhD,FCCM, Phone: +420 602 492 054, Email: cernyvla1960@gmail.com

Additional Information

Starting date: July 2015
Last updated: July 30, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017