CompletedPhase 4ACTRN12616000116426

Evaluating the Cough Evoked Response on emergence in patients undergoing general anaesthesia trial (ECER TRIAL)

A Randomized Controlled Trial (RCT) comparing reversal effect of rocuronium with neostigmine or sugammadex towards cough response on emergence in patients undergoing general anesthesia


Sponsor

Dr Loh Pui San

Enrollment

120 participants

Start Date

Nov 24, 2015

Study Type

Interventional

Conditions

Summary

The aim of this study is to compare the incidence of cough response during emergence in general anaesthesia with sugammadex or neostigmine as the reversal agent. We hope this study will help and guide clinicians to choose a safe and appropriate drug that can efficiently reverse the patient under general anesthesia with minimal risk of coughing on emergence and other adverse events. Hypothesis: Reversal of neuromuscular blockade with either sugammadex or neostigmine at the end of neurosurgery will result in difference in the grade of cough response during emergence. Different dosage of sugammadex used for reversal may have different outcome in cough response.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria5

  • Patients scheduled for elective or emergency operation under general relaxant anaesthesia
  • ASA I - III according to American Society of Anaesthesiologist guidelines.
  • Age 18 - 70 years old.
  • Aim for extubation at the end of surgery
  • Procedure duration of 1 hour to 6 hours

Exclusion Criteria6

  • Patient refusal (or legal guardian)
  • Planned to remain intubated and ventilated
  • Patient on tracheostomy
  • Any contraindication to rocuronium, neostigmine or sugammadex such as allergy, severe renal or liver impairment, coagulopathy and on OCP.
  • Evidence of raised ICP or IOP
  • Residual neuromuscular weakness affecting cough and gag

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Interventions

To compare reversal effect of rocuronium with neostigmine or sugammadex towards cough response on emergence in patients undergoing general anesthesia. At the end of the surgery, each patient will be r

To compare reversal effect of rocuronium with neostigmine or sugammadex towards cough response on emergence in patients undergoing general anesthesia. At the end of the surgery, each patient will be receiving different types of reversal agent, either: Group 1: Intravenous Sugammadex 2mg/kg (half dose given prior to extubation and another half exactly after extubation) Group 2: Intravenous Sugammadex full dose of 2mg/kg prior to extubation


Locations(1)

Petaling jaya, selangor, Malaysia

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ACTRN12616000116426