Effective September 2018, the Surgery 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 Surgery MISP in 2019. 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 following areas are of interest to the Investigator Studies Program Committee:
- NEUROMUSCULAR BLOCKADE (NMB):
- Impact of NMB (including deep block1) on surgical conditions, including intra-abdominal pressure, and other intra-operative outcomes for a variety of procedures, especially abdominal minimally invasive, robotic, ENT, ocular, orthopedic joint manipulation, thoracic, and neurosurgical.
- Impact of NMB (including deep block1) on peri-operative outcomes (see procedures above), including pulmonary, pain, nausea, vomiting, neurohumoral response, cardiac function, cognition, ambulation, swallowing, and overall patient or surgeon satisfaction.
- RESIDUAL NMB:
- Impact of residual NMB on postoperative recovery and/or other perioperative outcomes overall, and in special populations2
- Identify special populations2 at risk for postoperative pulmonary and other complications
- Impact of subjective vs. objective neuromuscular monitoring on achieving complete recovery at extubation and/or the rate of residual paralysis
- Develop clinical or digital methods to detect residual block
- EFFICIENCY and COMPARATIVE EFFECTIVENESS:
- Impact of reversal of NMB on efficiency and/or quality of patient care, including: time in the operating room, PACU, ICU, or hospital in various scenarios or in specific procedures; relevant hospital quality metrics; costs in various scenarios (inpatient; outpatient, other); patient populations2 and procedures; relevant clinical effectiveness endpoints
- Develop and/or validate methods to measure efficiency and/or quality
- ENHANCED RECOVERY PROTOCOLS:
- Contribution of neuro-muscular relaxant reversal and/or NMB (including deep block) on patient outcomes in specific surgical protocols.
1deep block = post-tetanic count of 1 or 2 twitches
Special 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.
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 full protocol and detailed budget via Visiontracker
, the Company's on-line study management system (in US) or your MSD country representative (outside US). The proposals will be collectively reviewed and selected by the Surgery MISP Committee.
Critical Activities and Timelines:
||1st Review Cycle
||2nd Review Cycle
||3rd Review Cycle
||4th Review Cycle
||5th Review Cycle
|Full Protocol Submission with Detailed Budget
||Jan 1, 2019
||Mar 1, 2019
||May 1, 2019
||Jul 1, 2019
||Sep 2, 2019
|Final Comments to Investigator
||Feb 8, 2019
||Apr 3, 2019
||Jun 7, 2019
||Aug 2, 2019
||Oct 9, 2019
|Final Protocol Submission by Investigator
||Feb 15, 2019
||Apr 19, 2019
||Jun 14, 2019
||Aug 16, 2019
||Oct 18, 2019
|Final Protocol Approval by Committee
||Feb 22, 2019
||Apr 24, 2019
||Jun 21, 2019
||Aug 23, 2019
||Oct 29, 2019