Effective July 2021, the Anesthesia Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) as noted below. This is a competitive process that will be conducted by the Anesthesia MISP in 2021. Decisions will be made on the basis of scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below. The program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.
The following areas are of interest to the Investigator Studies Program Committee:
- NEUROMUSCULAR BLOCKADE (NMB):
- Impact of NMB management on a variety of surgical procedures, including robotic, ENT, ophthalmologic, orthopedic joint manipulation, cardiothoracic, and neurosurgical/neuroradiological.
- Impact of NMB on perioperative outcomes (see procedures above), including pulmonary, cardiac function, cognition, gastrointestinal function, ambulation, swallowing/laryngeal function, and patient-reported/-centered outcomes.
- Impact of mechanism of reversal (Neo/Antimuscarinic vs Sugammadex) on autonomic dysfunction (Patient Outcomes /impact on healthcare resource utilization):
- GI: Postoperative Nausea and vomiting (PONV) and Impaired return of bowel function
- Urinary: Postoperative urinary retention (POUR)
- Cardiac: dysrhythmias and QT Dispersion
- RESIDUAL NMB:
- Impact of residual NMB on postoperative recovery and/or other perioperative outcomes overall, and in special populations1
- Identify special populations1 at risk for postoperative pulmonary and other complications
- Together with pharmacologic management, study the impact of assessment of adequate recovery from NMB with objective monitoring techniques intraoperatively and in the PACU, including evolving standards from TOF% ≥ 0.9 and related downstream healthcare outcomes. Investigate innovative clinical or digital methods to detect residual block.
- COMPARATIVE EFFECTIVENESS:
- Impact of reversal of NMB on quality of patient care, including relevant hospital quality metrics; pharmacoeconomic/related costs in various settings (e.g. inpatient, outpatient/ambulatory, institutions with varying patient volumes); patient populations, and procedures; relevant clinical effectiveness endpoints.
- PERI-OPERATIVE PROTOCOLS:
- Contribution of active neuromuscular relaxant reversal and/or NMB on patient outcomes in risk-stratification strategies, specific surgical pathways, and bundled care.
- ELECTRONIC MEDICAL RECORD-BASED QUALITY INITIATIVES:
- Develop and/or validate methods to measure quality including application of data analytics and data science techniques that drive decision-making and policy within the NMB and/or residual NMB arena.
1Special populations include but are not limited to: children, elderly, obese, those with burns, those with cardiac and/or pulmonary disease, those in special settings (intensive care, ambulatory, other), those with neuromuscular or psychiatric disorders, patients with chronic post-COVID-19 (specially with pulmonary fibrosis).
NOTE: Proposals specifying use of a TOF-watch device should consider the following country specific information: The EU and USA have no restrictions on TOF-watch use. Device registration will expire in China on 12Nov2019 and in Thailand on 28Oct2018. Investigators in other countries unsure of the status should contact their local MSD office.
Please complete a protocol with detailed budget via Visiontracker
, the Company's on-line study management system (in US). The proposals will be collectively reviewed and selected by the the Anesthesia MISP Committee.
Critical Activities and Timelines:
||1st Review Cycle
||2nd Review Cycle
||3rd Review Cycle
|Protocol Submission with Detailed Budget
||January 1, 2021
||May 1, 2021
||September 1, 2021
|Final Comments to Investigator
||February 8, 2021
||June 4, 2021
||October 8, 2021
|Final Protocol Submission by Investigator
||February 22, 2021
||June 18, 2021
||October 19, 2021
|Final Protocol Approval by Committee
||March 1, 2021
||June 25, 2021
||October 29, 2021