Ignite Creation Date:
2024-05-06 @ 8:47 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02825576
Status:
TERMINATED
Last Update Posted:
2023-03-29
First Post:
2016-06-21
Brief Title:
Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
Sponsor:
Northern Sydney Anaesthesia Research Institute
Organization:
Northern Sydney Anaesthesia Research Institute
Study Overview
Official Title:
Prevention of Postoperative Events Following Reversal With Sugammadex or Neostigmine
Status:
TERMINATED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Study Personnel
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P-PERSON
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
Detailed Description:
This is a local multi-centre prospective randomised double blinded trial of 976 patients
Objectives
The primary objective is to determine if the use of sugammadex compared with neostigmine reduces the rate of postoperative pulmonary complications PPCs Secondary objectives are to determine if the use of sugammadex compared with traditional reversal agents improves patient quality of recovery reduces the rate of postoperative nausea and vomiting and reduces the rate of airway complications in the Post Anaesthesia Care Unit PACU
Study procedures
Following informed consent prior to surgery patients will be randomised to two groups allocating drugs used for reversal of muscle relaxation
1 2mgkg sugammadex
2 50mcgkg neostigmine with 10mcgkg glycopyrrolate
Randomisation will be via computer generated numbers which will be sealed in opaque sequentially numbered envelopes
Treating anaesthetist and staff assessing outcomes will be blinded to treatment
Patients will have neuromuscular transmission NMT monitoring intraoperatively to ensure return of train-of-four count TOFC 2 prior to reversal Muscle relaxant will be limited to rocuronium or vecuronium at the choice of the individual anaesthetist As this study is planned to be a real world trial mode of anaesthesia analgesia postoperative nausea and vomiting PONV prophylaxis and time of reversal will be determined by the individual treating anaesthetist
Postoperative outcome data will be collected in the recovery unit on postoperative day 1 and 2 if still an inpatient at hospital discharge and via a 30 day post-operative phone call
Statistical Analysis
Conservatively estimating the baseline incidence of PPC at 7 baseline incidence and an equally conservative estimate that sugammadex can reduce this to 3 would produce a clinically relevant number needed to treat NNT of 29 Accepting an alpha error of 005 and beta error of 02 would require 930 patients Allowing for 5 incomplete data and loss to follow up requires 976 patients
Groups will be analysed on an intention-to-treat basis
1 PPC rate QoR-15 score and hospital stay will be assessed as continuous variables
2 Post operative Nausea and Vomiting PONV score will be assessed as an ordinal variable
3 Mortality and the presence of respiratory and PACU events will be assessed as categorical variables
The effect of sugammadex on continuous variables will be analysed by 2-tailed Student T-test The effect of sugammadex on ordinal and categorical variables will be analysed by Chi-squared tests Binomial regression analysis will be performed on the categorical outcomes for the subgroup analyses Logistic regression will be performed to analyse the effect of PONV risk on PONV scores
Appropriate statistical tests to confirm test assumptions are met will be performed In the case of non-parametric data the appropriate test will be performed Interim analysis is planned after 50 data completion
Objectives
The primary objective is to determine if the use of sugammadex compared with neostigmine reduces the rate of postoperative pulmonary complications PPCs Secondary objectives are to determine if the use of sugammadex compared with traditional reversal agents improves patient quality of recovery reduces the rate of postoperative nausea and vomiting and reduces the rate of airway complications in the Post Anaesthesia Care Unit PACU
Study procedures
Following informed consent prior to surgery patients will be randomised to two groups allocating drugs used for reversal of muscle relaxation
1 2mgkg sugammadex
2 50mcgkg neostigmine with 10mcgkg glycopyrrolate
Randomisation will be via computer generated numbers which will be sealed in opaque sequentially numbered envelopes
Treating anaesthetist and staff assessing outcomes will be blinded to treatment
Patients will have neuromuscular transmission NMT monitoring intraoperatively to ensure return of train-of-four count TOFC 2 prior to reversal Muscle relaxant will be limited to rocuronium or vecuronium at the choice of the individual anaesthetist As this study is planned to be a real world trial mode of anaesthesia analgesia postoperative nausea and vomiting PONV prophylaxis and time of reversal will be determined by the individual treating anaesthetist
Postoperative outcome data will be collected in the recovery unit on postoperative day 1 and 2 if still an inpatient at hospital discharge and via a 30 day post-operative phone call
Statistical Analysis
Conservatively estimating the baseline incidence of PPC at 7 baseline incidence and an equally conservative estimate that sugammadex can reduce this to 3 would produce a clinically relevant number needed to treat NNT of 29 Accepting an alpha error of 005 and beta error of 02 would require 930 patients Allowing for 5 incomplete data and loss to follow up requires 976 patients
Groups will be analysed on an intention-to-treat basis
1 PPC rate QoR-15 score and hospital stay will be assessed as continuous variables
2 Post operative Nausea and Vomiting PONV score will be assessed as an ordinal variable
3 Mortality and the presence of respiratory and PACU events will be assessed as categorical variables
The effect of sugammadex on continuous variables will be analysed by 2-tailed Student T-test The effect of sugammadex on ordinal and categorical variables will be analysed by Chi-squared tests Binomial regression analysis will be performed on the categorical outcomes for the subgroup analyses Logistic regression will be performed to analyse the effect of PONV risk on PONV scores
Appropriate statistical tests to confirm test assumptions are met will be performed In the case of non-parametric data the appropriate test will be performed Interim analysis is planned after 50 data completion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None