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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000116426

Acronym

ECER TRIAL

Enrollment

120

Registered

2016-02-02

Start date

2015-11-24

Completion date

2016-06-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Patients scheduled for elective or emergency operation under general relaxant anaesthesia 2. ASA I - III according to American Society of Anaesthesiologist guidelines. 3. Age 18 - 70 years old. 4. Aim for extubation at the end of surgery 5. Procedure duration of 1 hour to 6 hours

Exclusion criteria

1. Patient refusal (or legal guardian) 2. Planned to remain intubated and ventilated 3. Patient on tracheostomy 4. Any contraindication to rocuronium, neostigmine or sugammadex such as allergy, severe renal or liver impairment, coagulopathy and on OCP. 5. Evidence of raised ICP or IOP 6. Residual neuromuscular weakness affecting cough and gag

Outcome results