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Sedation Guidelines for Research Protocols Involving Diagnostic, Operative and Invasive Procedures

October 2003

The Johns Hopkins Hospital, Johns Hopkins Bayview Medical Center and Howard County General Hospital have hospital policies that define the way procedural sedation is to be performed in these organizations. These hospital policies have been approved by the Medical Boards and the Boards of Trustees. Policies of this kind are mandated by regulatory and professional bodies.

When the JHM IRBs review an application for human subjects research and the application involves sedation, the IRBs will require the PI to follow the policy of the hospital where the sedation takes place.  The full protocol guidelines with specific drug administration routes and doses can be found on the Internet, as provided below.  (For questions, the contact information is also provided.)

JHH: Policy:   http://www.insidehopkinsmedicine.org/hpo/policies/39/45/policy_45.pdf
Contact:  Sedation/Analgesia Subcommittee of the Risk Management Committee

JHBMC: Policy:  http://www.jhbmc.jhu.edu:8001/policies/pcpm/index.html
Contact: JHBMC – Pharmacy and Therapeutics Committee

HCGH: Policy:  Policy S-18 Guidelines for Moderate Sedation /Analgesia for Short Term Therapeutic and Diagnostic Procedures
Contact: HCGH – Pharmacy and Therapeutics Committe

When research subjects will receive sedation for a research procedure, the drug(s), dose(s) and risks should be in the protocol and the consent form should name the drugs and discuss the risks.  The protocol should state that the appropriate hospital policy for sedation will be followed.
 
Situations where the hospital sedation protocols do not apply:

  •  Patients receiving intravenous sedating drugs under approved treatment protocols (e.g. in oncology patients: lorazepam 1 mg IV administered as an anti-emitic before some types of chemotherapy)
  •  Use of pure anxiolytics (e.g. buspirone) or sedative drugs in a low dose given once and expected to have little sedative effect.
  •  An analgesic drug used alone for a procedure for control of pain or discomfort without use of concomitant drugs with sedative properties.
  • Patients who are endotracheally intubated and mechanically ventilated.

AAHRPP

 

 

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