Effect of Neostigmine on the Recovery of Rocuronium: A Comparison Between Partial and TOF Ratio-Based Dose

NCT03058263 | Completed Phase 1

• 1 other identifier: IndonesiaUAnes011
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the effect of Neostigmine partial dose towards neuromuscular blockade of rocuronium

Conditions

Muscle Relaxant; General Anesthesia

Outcome Measures

Primary Outcomes (4)

• TOF ratio with partial dose of neostigmine

  Train-of-Four ratio obtained from post-operative acceleromyography after the first partial dose of neostigmine had been administrated until definitive airway device can be removed

  Day 1

• TOF ratio with TOF ratio-based dose of neostigmine

  Day 1

• TOF ratio between partial dose of neostigmine and TOF ratio-based dose of neostigmine

  Day 1

• time needed to reach TOF ratio ≥ 90% in group with partial dose of neostigmine

  Day 1

Study Arms (2)

partial dose of neostigmine

EXPERIMENTAL

Those who received partial dose of neostigmine as rocuronium reversal

Drug: Dose of Neostigmine

TOF ratio-based dose of neostigmine

EXPERIMENTAL

Those who received TOF ratio-based dose of neostigmine as rocuronium reversal

Drug: Dose of Neostigmine

Interventions

Dose of Neostigmine DRUG

Subjects were given partial dose of neostigmine as rocuronium reversal after the surgery had finished; subjects were given TOF ratio-based dose of neostigmine after the surgery had finished

Also known as: prostigmin

TOF ratio-based dose of neostigmine; partial dose of neostigmine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients aged 18-60 years old
• American Society of Anesthesiologists (ASA) physical status I-II who were planned to undergo any elective surgery at operating room in general anesthesia
• subjects had been explained about the study, and agreed to enroll and have signed the informed consent form

You may not qualify if:

• BMI ≥ 30
• had any severe kidney or liver disease
• had neuromuscular disease or asthma
• Drop out Criteria:
• Duration of operation less than one hour or more than 2 hours
• during surgery received maintenance dose of neuromuscular block
• intraoperative cardiac arrest was occurred

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (16)

• Maybauer DM, Geldner G, Blobner M, Puhringer F, Hofmockel R, Rex C, Wulf HF, Eberhart L, Arndt C, Eikermann M. Incidence and duration of residual paralysis at the end of surgery after multiple administrations of cisatracurium and rocuronium. Anaesthesia. 2007 Jan;62(1):12-7. doi: 10.1111/j.1365-2044.2006.04862.x.

  PMID: 17156221 BACKGROUND

• Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4.

  PMID: 20442260 BACKGROUND

• Thilen SR, Hansen BE, Ramaiah R, Kent CD, Treggiari MM, Bhananker SM. Intraoperative neuromuscular monitoring site and residual paralysis. Anesthesiology. 2012 Nov;117(5):964-72. doi: 10.1097/ALN.0b013e31826f8fdd.

  PMID: 23001053 BACKGROUND

• Donati F. Residual paralysis: a real problem or did we invent a new disease? Can J Anaesth. 2013 Jul;60(7):714-29. doi: 10.1007/s12630-013-9932-8. Epub 2013 Apr 27.

  PMID: 23625545 BACKGROUND

• Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.

  PMID: 12717123 BACKGROUND

• Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386.

  PMID: 17307778 BACKGROUND

• Song IA, Seo KS, Oh AY, No HJ, Hwang JW, Jeon YT, Park SH, Do SH. Timing of reversal with respect to three nerve stimulator end-points from cisatracurium-induced neuromuscular block. Anaesthesia. 2015 Jul;70(7):797-802. doi: 10.1111/anae.13044. Epub 2015 Feb 27.

  PMID: 26580249 BACKGROUND

• Sundman E, Witt H, Olsson R, Ekberg O, Kuylenstierna R, Eriksson LI. The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium. Anesthesiology. 2000 Apr;92(4):977-84. doi: 10.1097/00000542-200004000-00014.

  PMID: 10754616 BACKGROUND

• Viby-Mogensen J. Postoperative residual curarization and evidence-based anaesthesia. Br J Anaesth. 2000 Mar;84(3):301-3. doi: 10.1093/oxfordjournals.bja.a013428. No abstract available.

  PMID: 10793585 BACKGROUND

• Brull SJ, Murphy GS. Residual neuromuscular block: lessons unlearned. Part II: methods to reduce the risk of residual weakness. Anesth Analg. 2010 Jul;111(1):129-40. doi: 10.1213/ANE.0b013e3181da8312. Epub 2010 May 4.

  PMID: 20442261 BACKGROUND

• American Society of Anesthesiologists Task Force on Postanesthetic Care. Practice guidelines for postanesthetic care: a report by the American Society of Anesthesiologists Task Force on Postanesthetic Care. Anesthesiology. 2002 Mar;96(3):742-52. doi: 10.1097/00000542-200203000-00033. No abstract available.

  PMID: 11873052 BACKGROUND

• Naguib M, Kopman AF, Lien CA, Hunter JM, Lopez A, Brull SJ. A survey of current management of neuromuscular block in the United States and Europe. Anesth Analg. 2010 Jul;111(1):110-9. doi: 10.1213/ANE.0b013e3181c07428. Epub 2009 Nov 12.

  PMID: 19910616 BACKGROUND

• Naguib M, Samarkandi AH, Bakhamees HS, Magboul MA, el-Bakry AK. Histamine-release haemodynamic changes produced by rocuronium, vecuronium, mivacurium, atracurium and tubocurarine. Br J Anaesth. 1995 Nov;75(5):588-92. doi: 10.1093/bja/75.5.588.

  PMID: 7577286 BACKGROUND

• Whalley DG, Maurer WG, Knapik AL, Estafanous FG. Comparison of neuromuscular effects, efficacy and safety of rocuronium and atracurium in ambulatory anaesthesia. Can J Anaesth. 1998 Oct;45(10):954-9. doi: 10.1007/BF03012303.

  PMID: 9836032 BACKGROUND

• Grayling M, Sweeney BP. Recovery from neuromuscular blockade: a survey of practice. Anaesthesia. 2007 Aug;62(8):806-9. doi: 10.1111/j.1365-2044.2007.05101.x.

  PMID: 17635429 BACKGROUND

• Kopman AF. Managing neuromuscular block: where are the guidelines? Anesth Analg. 2010 Jul;111(1):9-10. doi: 10.1213/ANE.0b013e3181cdb0a5. No abstract available.

  PMID: 20576960 BACKGROUND

Related Links

• Van Pelt M, Chitilian HV, Eikerman M. Multi-faceted initiative designed to improve safety of neuromuscular blockade. APSF. 2016; 30: 45-76

MeSH Terms

Conditions

Muscle Hypotonia

Interventions

Neostigmine

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Arif HM Marsaban, Consultant

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist Consultant

Study Record Dates

• First Submitted: February 12, 2017
• First Posted: February 20, 2017
• Study Start: October 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 28, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

ID (1)