Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine (P-PERSON)
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|ClinicalTrials.gov Identifier: NCT02825576|
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : August 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Complications||Drug: Sugammadex Drug: Neostigmine/Glycopyrrolate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||976 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine|
|Actual Study Start Date :||December 3, 2018|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||July 2021|
Active Comparator: Sugammadex group
Sugammadex 2mg/kg intravenously at completion of surgery.
Sugammadex 2mg/kg given for reversal agent
Other Name: Bridion
Active Comparator: Neostigmine/Glycopyrrolate group
Neostigmine 50mcg/kg plus Glycopyrrolate 10mcg/kg intravenously at completion of surgery.
Neostigmine 50 mcg/kg plus Glycopyrrolate 10 mcg/kg given for reversal agent
- Incidence of post operative pulmonary complications. [ Time Frame: Up to day 2 post operatively. ]Incidence of Postoperative pulmonary complications as defined by The Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) group.
- Quality of Recovery Score (QoR-15) [ Time Frame: Day 1 and Day 30 post operatively ]A 15- item patient-rated post operative questionnaire designed to assess the early postoperative health status of patients after anesthesia and surgery.
- Incidence of post operative nausea and vomiting. [ Time Frame: Day of surgery. ]
Post Operative Nausea and Vomiting (PONV) Score:
- - no PONV
- - PONV responsive to antiemetics
- - PONV unresponsive to antiemetics
- Incidence of airway events in the Post Anaesthesia Care Unit (PACU). [ Time Frame: Day of surgery. ]
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
- Mortality [ Time Frame: 30 day ]Death of patient within time frame.
- Hospital stay [ Time Frame: 30 days ]Duration of hospital stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825576
|Contact: Ben L Olesnicky, BMBS Bsc||+61 2 9463 email@example.com|
|Australia, New South Wales|
|Royal North Shore Hospital||Recruiting|
|St Leonards, New South Wales, Australia, 2065|
|Contact: Dr Olesnicky|
|Principal Investigator:||Ben L Olesnicky, BMBS BSc||Northern Sydney Anaesthesia Research Institute|