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Clinical Hub,References,Adult Moderate Sedation Topics

Informed Consent

Informed Consent - Clinical Hub, References, Adult Moderate Sedation Topics


Discuss the risks, benefits and alternatives to the procedure, with and without sedation, with the patient and/or family members as appropriate. Include post procedural expectations such as management of any post procedure pain and anticipated short and long term changes in activities of daily living. Ensure that patients or legal surrogates understand the proposed treatment and its potential complications. Ask each patient or legal surrogate to recount what he or she has been told during the informed consent. (Leapfrog). By providing pre procedure patient education, the physician can allay patient fears and anxiety regarding the planned procedure. These measures can lead to a decrease in the dosage of medications needed for sedation (Yaney, 1998). 

Document consent as outlined in hospital policy 4.17 Informed Consent including date and time consent was obtained. The following outlines the various categories of medical care and the corresponding documentation required for each category, as it relates to sedation: 

Signed Consent 

Signed consent generally means a consent form or statement signed by the patient or representative. It is required for:

Documented Consent 

Documented consent includes signed consent (see above) or a note included in the patient chart outlining risks/benefits/alternatives to the plan of care. It should be signed by the responsible physician and note that the patient/representative understands and agrees to proceed with the plan as discussed. It includes:

In an emergency, when the patient is unable to give consent and delaying medical care until a patient’s authorized representative can be found risks serious injury to health or significant pain, medical care may be given to the extent needed to respond to the emergency needs of the patient, provided there is no known advance directive to the contrary. In case of doubt concerning the validity or applicability of an advance directive directing withholding treatment, emergency medical care should be given. When possible, attempts to obtain consent of the patient or the patient’s authorized representative should continue while care is given. The responsible physician determines the existence of an emergency. It is advisable to document in the medical record the nature of the emergency and the efforts made to obtain consent. 

No patient shall receive sedation until a pre-sedation assessment has been completed and documented by the physician responsible for the sedation. Documentation includes the patient’s appropriateness to receive sedation. 

The person administering the sedation medication (generally the qualified RN) is responsible for assuring the requirements are completed before administering medication. A procedure will be delayed or cancelled until all pre-procedure documentation is complete. This includes:

Establish Venous Access 

Establish venous access, if appropriate, for the administration of intravenous sedation and ready access should additional medications or IV fluids required during or after the procedure. The responsible physician determines the need for venous access. 

Obtain Necessary Equipment 

Because the potential for respiratory depression exists, resuscitative equipment needs to be readily available. Allow time for and coordinate equipment availability and set-up with nursing staff. A qualified RN will determine that the following resuscitative and monitoring equipment are available: