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Comparing Reversal With Neostigmine and Sugammadex in Paediatric

NCT03137290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-05-02

No results posted yet for this study

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.

Conditions

  • Neuromuscular Blockade

Interventions

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.

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.

Sponsors & Collaborators

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Rhendra Hardy Mohamad Zaini, MD · Universiti Sains Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-01
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03137290 on ClinicalTrials.gov