Neuromuscular Blockade Improves Surgical Conditions

NCT00895778 | Completed DMC

• 1 other identifier: NISCO
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test the clinical hypothesis that a neuromuscular block improves surgical conditions, operation time, and post-operative pain.

Conditions

Neuromuscular Blockade

Keywords

Neuromuscular blockade; post-operative pain; post-operative pulmonary function

Outcome Measures

Primary Outcomes (1)

• Postoperative patient-controlled analgesic demand for adequate pain control

  Regular anesthesia time, approximately 1 hour

Secondary Outcomes (4)

• Incidence of intraoperative muscle movements

• Incision-to-suture-time

• Surgeon's and anesthesiologist's opinion about the operating conditions assessed by a visual analogue scale (VAS)

• Postoperative pulmonary function

Study Arms (2)

NMB

EXPERIMENTAL

muscle relaxation (neuromuscular block) during laparoscopic cholecystectomy

Other: Neuromuscular blockade with rocuronium and reversal with sugammadex

no NMB

PLACEBO COMPARATOR

no muscle relaxation (neuromuscular block) during laparoscopic cholecystectomy

Other: Neuromuscular blockade with rocuronium and reversal with sugammadex

Interventions

Neuromuscular blockade with rocuronium and reversal with sugammadex OTHER

NMB; no NMB

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for elective laparoscopic cholecystectomy under general anesthesia
• Patients ASA physical status I - III
• Patients between 18 and 64 years
• Patients scheduled for general anesthesia with intubation using rocuronium
• Patients having given informed consent to the study

You may not qualify if:

• Anatomic and functional malformations with expected difficult intubation
• Known or suspected neuromuscular disease
• Significant hepatic or renal dysfunction
• Known or suspected history or family history of disposition to malignant hyperthermia
• Known or suspected allergy towards sugammadex, anesthetics, muscle relaxants, or other drugs used for general anesthesia
• Use of drugs that interfere with muscle relaxants
• Patients, included in another trial within the last 30 days
• Patients, with legal guidant
• Patients with contraindication towards the use of Sugammadex, neostigmine or glycopyrrolate
• Patients, which have already participated in a sugammadex trial
• Breastfeeding women
• Patients who are unable to understand or successfully administer a patient- controlled-analgesia (PCA) device

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

Location

Related Publications (4)

• Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.

  PMID: 18946293 BACKGROUND

• Puhringer FK, Rex C, Sielenkamper AW, Claudius C, Larsen PB, Prins ME, Eikermann M, Khuenl-Brady KS. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008 Aug;109(2):188-97. doi: 10.1097/ALN.0b013e31817f5bc7.

  PMID: 18648227 BACKGROUND

• Flockton EA, Mastronardi P, Hunter JM, Gomar C, Mirakhur RK, Aguilera L, Giunta FG, Meistelman C, Prins ME. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2.

  PMID: 18385265 BACKGROUND

• Blobner M, Frick CG, Stauble RB, Feussner H, Schaller SJ, Unterbuchner C, Lingg C, Geisler M, Fink H. Neuromuscular blockade improves surgical conditions (NISCO). Surg Endosc. 2015 Mar;29(3):627-36. doi: 10.1007/s00464-014-3711-7. Epub 2014 Aug 15.

  PMID: 25125097 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Neuromuscular Blockade; Rocuronium; Sugammadex

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Investigative Techniques; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Manfred Blobner, MD

  Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: May 8, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: March 19, 2013

Record last verified: 2013-03

Locations

DE (1)