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

NCT ID: NCT03058263

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-02-28

Brief Summary

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

Detailed Description

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannula with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on the subjects in the operation room. After preoxygenation was given with 100% oxygen, general anesthesia induction was done with midazolam 0.01-0.02 mg/kg, fentanyl 3 mcg/kg, propofol 1-2 mg/kg, and rocuronium 0.6 mg/kg. Following induction, endotracheal intubation or laryngeal mask insertion was performed. Maintenance was done by sevoflurane 1.2 vol%, and fentanyl 1.2 mcg/kg. After the surgery had finished, fentanyl drip was stopped. Subjects were then observed until spontaneous breaths occured adequately (tidal volume ≥ 5 ml/kg) before train of four (TOF) ratio was evaluated using acceleromyography (AMG). Before reversal (neostigmine) was given, anesthetic gas was stopped and duration of operation as well as post-operative TOF ratio was recorded. The time since reversal was given then recorded. Group A received neostigmine partial dose (0.02 mg) in combination with atropine 0.4 mg for every milligram of neostigmine. Group B received TOF ratio-based dose of neostigmine in combination with atropine 0.4 mg for every milligram of neostigmine. After administration of neostigmine, TOF ratio was measured every 5 minutes until TOF ratio of ≥ 90% was achieved, and finally definitive airway could be removed. For Group A, another partial dose of neostigmine was given after 10 minutes from the first reversal dose if the TOF ratio of ≥90% had not been reached. For Group B, another TOF ratio-based dose of neostigmine was given after 10 minutes from the first reversal dose if the TOF ratio of ≥90% had not been reached. Subjects were then transported to recovery room. Data was analyzed using Statistical Package for the Social Sciences (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.

Conditions

Muscle Relaxant; General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

partial dose of neostigmine

Those who received partial dose of neostigmine as rocuronium reversal

Group Type: EXPERIMENTAL

Dose of Neostigmine

Intervention Type: 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

TOF ratio-based dose of neostigmine

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

Group Type: EXPERIMENTAL

Dose of Neostigmine

Intervention Type: 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

Interventions

Dose of Neostigmine

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

Intervention Type: DRUG

Other Intervention Names

prostigmin

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Arif H. M. Marsaban

Anesthesiologist Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arif HM Marsaban, Consultant

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

References

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.

Reference Type: BACKGROUND

PMID: 17156221 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20442260 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23001053 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23625545 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12717123 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17307778 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26580249 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10754616 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10793585 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20442261 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11873052 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19910616 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7577286 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9836032 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17635429 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20576960 (View on PubMed)

Related Links

http://www.apsf.org/newsletters/pdf/Feb2016final_lores.pdf

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

Other Identifiers

IndonesiaUAnes011

Identifier Type: -

Identifier Source: org_study_id