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Trial registered on ANZCTR


Registration number
ACTRN12616000116426
Ethics application status
Approved
Date submitted
18/06/2015
Date registered
2/02/2016
Date last updated
8/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the Cough Evoked Response on emergence in patients undergoing general anaesthesia trial (ECER TRIAL)
Scientific title
A Randomized Controlled Trial (RCT) comparing reversal effect of rocuronium with neostigmine or sugammadex towards cough response on emergence in patients undergoing general anesthesia
Secondary ID [1] 286775 0
nil
Universal Trial Number (UTN)
Trial acronym
ECER TRIAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Evoked cough response on emergence 295152 0
Changes in vital signs such as blood pressure, heart rate as part of the sympathetic response during emergence 295744 0
Condition category
Condition code
Anaesthesiology 295392 295392 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 291932 0
Treatment: Drugs
Comparator / control treatment
Group 3 : Intravenous Neostigmine 0.05mg/kg + Glycopyrrolate 400 mcg
Control group
Active

Outcomes
Primary outcome [1] 295131 0
To compare the incidence of severe cough on emergence in patient undergoing general anesthesia receiving two types of reversal agents with different dosage.
Assessment done by the investigator who is blinded based on a reference table of cough severity.
Timepoint [1] 295131 0
The emergence phase will be considered starting at the time of discontinuation of the volatile or intravenous anaesthetic agents until 5 minutes after tracheal extubation, during which the patient will be intermittently stimulated at 1-2 minutes interval verbally or with gentle tactile stimulation. Once clinically suitable to reverse, the attending anesthetist will administer the study drug for reversal of muscle relaxant.
Secondary outcome [1] 314823 0
To look at parameters associated with severity of cough on emergence such as sympathetic activation on emergence
i) Blood pressure using sphygnomanometer(hypertension; SBP>160 or DBP >90)
ii) Heart rate on ECG (tachycardia; >100 )
Timepoint [1] 314823 0
Monitored every 10 minutes from time of emergence to time of discharge to the ward
Secondary outcome [2] 316238 0
To compare reversal time taken by each drug at different dosages
Timepoint [2] 316238 0
Time from discontinuation of anaesthetic gas or intravenous anaesthesia to extubation
Secondary outcome [3] 316240 0
To compare the incidence of post-operative complications such as unplanned ICU admission, residual paralysis, respiratory complications and nausea/ vomiting by reviewing anaesthetic charts in the post anaesthetic recovery area

Timepoint [3] 316240 0
Time from extubation until patient is discharged to the ward

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Once all inclusion criteria have been fulfilled and all exclusion criteria have been excluded, patients will be recruited from both elective and emergency lists in operating theatre.
2. Consent is taken from the patient and each of them will be given a patient information sheet.
3. The sealed envelope corresponding to the research ID will be opened:
Group 1 : Sugammadex 2mg/kg (half dose given prior to extubation and another half exactly after extubation)
Group 2 : Sugammadex full dose of 2mg/kg prior to extubation
Group 3 : Neostigmine 0.05mg/kg + Glycopyrrolate 200 mcg
The attending anesthetist is unblinded and will prepare the reversal drugs required according to the randomized drug groups.



Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization:

A computer generated randomization method is used for this study. The patients will be randomly allocated a unique ID no and a study group to receive either sugammadex or neostigmine at the end of surgery. The allocation will be prepared by the research assistant and sealed in an envelope. Both the patient and the research personnel, who are present during general anesthesia, will be blinded till completion of the study. Unblinding of the researcher is done in case of medical emergency when the identity of the study drug must be revealed ( eg in case of suspected anaphylaxis to the study drugs). Any adverse events likely resulting from study drugs participation will be reported to the Ethics Committee.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size calculation was performed using OpenEpi version 3.03 open source software. A total of 120 patients with n=40 per arm of the trial is required to achieve a=0.05 and power (1-ß) >80%. Estimation was based on 15% reduction of main outcome in the intervention group.The three arms include sugammadex group 1 (1mg/kg for reversal and another 1mg/kg post extubation) , sugammadex group 2 (2mg/kg) and neostigmine/glycopyrrolate group (0.05mg/kg and 200mcg). CHI SQUARE test and multivariate analysis to analyze the results.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6893 0
Malaysia
State/province [1] 6893 0
Petaling jaya, selangor

Funding & Sponsors
Funding source category [1] 291320 0
University
Name [1] 291320 0
Postgraduate Research Grant (PPP) - Course & Disertation , University of Malaya
Address [1] 291320 0
Postgraduate Research Grant (PPP) - Course & Dissertation University of Malaya, Jalan Lembah Pantai,
59100 Wilayah Persekutuan Kuala Lumpur,
Malaysia
Country [1] 291320 0
Malaysia
Primary sponsor type
Individual
Name
Dr Loh Pui San
Address
Consultant Lecturer,
Department of Anaesthesia & Intensive Care,
University of Malaya, Jalan Lembah Pantai,
59100 Wilayah Persekutuan Kuala Lumpur,
Malaysia
Country
Malaysia
Secondary sponsor category [1] 290048 0
Commercial sector/Industry
Name [1] 290048 0
MSD Malaysia
Address [1] 290048 0
Merck Sharp & Dohme Sdn Bhd
T2-9, Jaya 33, No 3 (Lot 33)
Jalan Semangat, Section 13,
46200 Petaling Jaya
Selangor
Malaysia
Country [1] 290048 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292928 0
medical ethics committee of University of Malaya Medical Centre
Ethics committee address [1] 292928 0
University malaya medical ethics committee,
Quality department,
university of malaya medical centre,
Lembah Pantai,
59100 Kuala Lumpur
Ethics committee country [1] 292928 0
Malaysia
Date submitted for ethics approval [1] 292928 0
09/06/2015
Approval date [1] 292928 0
23/11/2015
Ethics approval number [1] 292928 0
MECID.NO: 20156-1389

Summary
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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 472 472 0 0
Attachments [2] 474 474 0 0

Contacts
Principal investigator
Name 57494 0
Dr Pui-San Loh
Address 57494 0
Department of Anaesthesiology and Intensive Care,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country 57494 0
Malaysia
Phone 57494 0
+60379492052
Fax 57494 0
Email 57494 0
lohps@um.edu.my
Contact person for public queries
Name 57495 0
Dr Maizatulhikma Md Miskan
Address 57495 0
Department of Anaesthesiology and Intensive Care,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country 57495 0
Malaysia
Phone 57495 0
+60379492052
Fax 57495 0
Email 57495 0
maizatulhikma@ummc.edu.my
Contact person for scientific queries
Name 57496 0
Dr Pui-San Loh
Address 57496 0
Department of Anaesthesiology and Intensive Care,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country 57496 0
Malaysia
Phone 57496 0
+60379492052
Fax 57496 0
Email 57496 0
lohps@um.edu.my

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary