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Comparing Reversal With Neostigmine and Sugammadex in Paediatric (JS)

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ClinicalTrials.gov Identifier: NCT03137290
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Rhendra Hardy Mohamad Zaini, Universiti Sains Malaysia

Brief Summary:

A reversal agent is commonly given to improve neuromuscular function after intra-operative administration of non-depolarizing neuromuscular blocking agents. The administration of conventional reversal agent neostigmine is associated with many undesirable side effects. For almost a decade, a new novel drug sugammadex has been used to specifically antagonize the effect of aminosteroidal neuromuscular blocking agents.

A total of 80 paediatric patients planned for general anaesthesia were divided into two groups and were given either neostigmine+atropine, or sugammadex for reversal once the operation had completed.


Condition or disease Intervention/treatment Phase
Neuromuscular Blockade Drug: Neostigmine Drug: Sugammadex Sodium Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between the Efficacy of Neostigmine Versus Sugammadex Reversal of Rocuronium Induced Neuromuscular Blockade In Paediatric Patients.
Actual Study Start Date : December 1, 2014
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : June 30, 2016

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Arm Intervention/treatment
Active Comparator: Neostigmine
1 mg of Atropine (1ml) was mixed with 2.5mg of Neostigmine (1ml) and diluted into 10mls with Normal Saline 0.9% in a 10ml standard syringe.
Drug: Neostigmine
The TOF Watch Sx, and Paediatric Bispectral Index (BIS) monitoring were put on patient. Gaseous induction, with oxygen and Sevoflurane was given until BIS was 40-50, then a intravenous line was obtained. 2 mcg/kg of fentanyl was given for analgesia. then,the TOF Watch Sx was calibrated.The patient was paralyzed with 0.6mg/kg of rocuronium, and intubation of the trachea was done once TOF count was less than 1. A maintenance of 0.2 mg/kg of Rocuronium was given boluses every 30 minutes to maintain TOF count between 2-3. At the end of surgery, TOF count was checked to ensure it was between 2-3. Then a reversal dose for TOF count of 2 to 3 was 0.05 mg/kg of Neostigmine with 0.02 mg/kg of Atropine. Therefore the volume would be 0.2 mls per kg is to be administered.
Other Name: Prostigmine

Experimental: Sugammadex sodium
100mg Sugammadex (1ml) is diluted into 10mls in a standard 10mls syringe with Normal Saline 0.9%.
Drug: Sugammadex Sodium
The TOF Watch Sx, and Paediatric Bispectral Index (BIS) monitoring were put on patient. Gaseous induction, with oxygen and Sevoflurane was given until BIS was 40-50, then a intravenous line was obtained. 2 mcg/kg of fentanyl was given for analgesia. then,the TOF was calibrated.The patient was paralyzed with 0.6mg/kg of rocuronium, and intubation of the trachea was done once TOF count was less than 1. A maintenance of 0.2 mg/kg of Rocuronium was given boluses every 30 minutes to maintain TOF count between 2-3. At the end of surgery, TOF count was checked to ensure it between 2-3. Then the dose for reversal of sugammadex with a TOF count of 2 or 3 would be 2 mg/kg. This will also be equivalent to a volume of 0.2 mls per kg and given at the end of surgery.
Other Name: Bridion




Primary Outcome Measures :
  1. Recovery time [ Time Frame: From the time the reversal drugs (neostigmine or sugammadex) were given at TOF count of 2-3 till the TOF ratio is more than 0.9 up to 5 minutes after the operation finished ]
    To assess the recovery time from TOF count of 2 or 3 to TOF ratio of more than 0.9 between neostigmine or sugammadex in reversal of rocuronium induced neuromuscular blockade in paediatric patients.


Secondary Outcome Measures :
  1. Adequate ventilation [ Time Frame: From the time of the reversal drugs (neostigmine or sugammadex) were given till patient achieved good ventilation (tidal volume 6 ml/kg) up to 5 minutes after the operation finished ]
    To evaluate the time from administration of reversal to adequate ventilation (tidal volume at least 6mls/kg and adequate respiratory rate for age)

  2. Extubation time [ Time Frame: From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is extubated up to 5 minutes after the operation finished. ]
    To evaluate the time from administration of reversal to extubation

  3. Blood Pressure [ Time Frame: From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes. ]
    Blood pressure was documented in 5 minute intervals upon administration of the reversal agent and in the the recovery bay.

  4. Heart Rate [ Time Frame: From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes. ]
    Heart rate was documented in 5 minute intervals upon administration of the reversal agent and in the the recovery bay.

  5. Oxygen saturation [ Time Frame: From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes. ]
    Oxygen saturation was documented in 5 minute intervals upon administration of the reversal agent and in the the recovery bay.

  6. Number of patients with treatment related-adverse event as assessed by clinical observation [ Time Frame: From the time of the patient extubated until the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes. ]
    To monitor any incidence of treatment related-adverse event post extubation



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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anaesthesiologist (ASA) physical status 1 and 2.
  • Paediatric patients within the above criteria whom require rocuronium induced neuromuscular blockage for general anaesthesia

Exclusion Criteria:

  • Active or recent upper respiratory tract infection (within 2 weeks)
  • Haemodynamically unstable patients for example trauma, haemorrhage, sepsis, thyrotoxic or cardiac failure
  • Patients with pre-existing neuromuscular disorders
  • Patients with renal failure, with creatinine clearance of less than 30mmol/L
  • Patients requiring post-operative ventilation
  • Patients with known allergy to sugammadex or neostigmine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137290


Locations
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Malaysia
University of Science Malaysia Hospital
Kubang Kerian, Kelantan, Malaysia, 16150
Sponsors and Collaborators
Universiti Sains Malaysia
Investigators
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Principal Investigator: Rhendra Hardy Mohamad Zaini, MD Universiti Sains Malaysia
Publications of Results:
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Responsible Party: Rhendra Hardy Mohamad Zaini, Doctor, Universiti Sains Malaysia
ClinicalTrials.gov Identifier: NCT03137290    
Other Study ID Numbers: JEPeM/281.3(3)
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhendra Hardy Mohamad Zaini, Universiti Sains Malaysia:
Paediatric general anaesthesia
Rocuronium
Neostigmine
Sugammadex
Additional relevant MeSH terms:
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Neostigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents