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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02825576

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
Scientific title
Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Complications 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Sugammadex
Treatment: Drugs - Neostigmine/Glycopyrrolate

Active Comparator: Sugammadex group - Sugammadex 2mg/kg intravenously at completion of surgery.

Active Comparator: Neostigmine/Glycopyrrolate group - Neostigmine 50mcg/kg plus Glycopyrrolate 10mcg/kg intravenously at completion of surgery.

Treatment: Drugs: Sugammadex
Sugammadex 2mg/kg given for reversal agent

Treatment: Drugs: Neostigmine/Glycopyrrolate
Neostigmine 50 mcg/kg plus Glycopyrrolate 10 mcg/kg given for reversal agent

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Incidence of post operative pulmonary complications. - Incidence of Postoperative pulmonary complications as defined by The Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) group.
Timepoint [1] 0 0
Up to day 2 post operatively.
Secondary outcome [1] 0 0
Quality of Recovery Score (QoR-15) - A 15- item patient-rated post operative questionnaire designed to assess the early postoperative health status of patients after anesthesia and surgery.
Timepoint [1] 0 0
Day 1 and Day 30 post operatively
Secondary outcome [2] 0 0
Incidence of post operative nausea and vomiting. - Post Operative Nausea and Vomiting (PONV) Score:
- no PONV
- PONV responsive to antiemetics
- PONV unresponsive to antiemetics
Timepoint [2] 0 0
Day of surgery.
Secondary outcome [3] 0 0
Incidence of airway events in the Post Anaesthesia Care Unit (PACU). - Proportion of patient that exhibit one or more of the following PACU Events (recorded by recovery room nursing staff);
Any desaturation to oxygen saturation by pulse oximetry (SpO2) <90%
Need for manual airway support
Need for oropharyngeal or nasopharyngeal airway
Need for reintubation in PACU
Need for anaesthetist to review the patient
Unplanned Intensive Care Unit (ICU) admission
Timepoint [3] 0 0
Day of surgery.
Secondary outcome [4] 0 0
Mortality - Death of patient within time frame.
Timepoint [4] 0 0
30 day
Secondary outcome [5] 0 0
Hospital stay - Duration of hospital stay
Timepoint [5] 0 0
30 days

Key inclusion criteria
- age >18

- patients presenting for non-cardiac surgery

- planned operative time of over 1 hour

- plan to be intubated and to receive muscle relaxants for their surgery

- plan to stay at least one night in hospital
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Previous recruitment to the trial

- Hypersensitivity to any of the study drugs

- Patient refusal

- Cognitive Impairment, or language proficiency leading to inability to complete QoR-15

- Body Mass Index (BMI) >40

- Planned postoperative intubation and ventilation

- Liver failure with Child-Pugh class B/C

- Renal failure with either regular peritoneal or haemodialysis or serum creatinine

- Women lactating, pregnant or of childbearing potential who are not willing to avoid
pregnancy during the study

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Northern Sydney Anaesthesia Research Institute
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Name [2] 0 0
Northern Sydney and Central Coast Area Health Service
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Brief summary
The purpose of this study is to determine if the use of sugammadex (compared with
neostigmine) reduces the rate of postoperative pulmonary complications (PPCs).
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Ben L Olesnicky, BMBS BSc
Address 0 0
Northern Sydney Anaesthesia Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ben L Olesnicky, BMBS Bsc
Address 0 0
Country 0 0
Phone 0 0
+61 2 9463 2488
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02825576