Anaesthesia Department POLICY AND PROCEDURE

Number: AHH-ANA 006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 1 of 15

1.0

Title: Conscious Sedation (Moderate Sedation/Analgesia)

2.0 their 3.0

Condition: Applies to all qualified Al Hammadi Hospital Anaesthesia Department and privileged staff using Conscious Sedation Techniques. Purpose: To discuss and describe the standards of care for patients undergoing procedural moderate sedation/analgesia (Conscious Sedation).

4.0

Definition:

The term conscious sedation is used to describe the act of giving medication to alleviate anxiety and/or pain associated with potentially unpleasant procedures. 5.0 Classification: The level or depth of sedation/analgesia can be classified as defined by the American Society of Anesthesiologists (ASA). Minimal Sedation (Anxiolysis) is a drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired,ventilatory and cardiovascular functions are unaffected. 5.1

Number: 006

AHH-ANA-

Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 2 of 15

Moderate Sedation/Analgesia (Conscious Sedation) is a drug induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. Nointerventions are required to maintain a patients airway and spontaneous ventilation is adequate. Cardiovascular function is usually unaffected. Deep Sedation / Analgesia is a drug-induced state of depressed consciousness during which patient cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. 6.0 Policy: 6.1 The areas The areas where conscious sedation is administered are identified and are approved by the chief of anesthesia. These areas include: 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6 6.1.7 6.2 The Staff Qualified Staff who are certified or who have successfully completed an Advanced Cardiac Life Support (ACLS) course, a Pediatric Advanced Life Support (PALS) course or a Neonatal Resuscitation Program (NRP) should Endoscopy Unit Intensive Care Unit Radiology Areas-MRI Cardiac Catheterization Laboratory ESWL AED Nuerophysiology-EEG 5.3

5.2

Number: AHH-ANA-006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 3 of 15

provide sedation. Persons familiar with the drugs used and prepared to deal with any potential complications . The Qualified Staff includes: 6.2.1 Attending Clinician Conscious sedation is ordered only by physician who is responsible for performing the procedure/examination using conscious sedation and who is primarily responsible for the health care of the patient. This physician has been given privileges to order conscious sedation by the chief of anesthesia and medical director. 6.2.2 Performing Clinician Refers to the medical staff clinician who is performing the procedure and who is privileged to perform procedural sedation, moderate or deep. The performing clinician can also be the attending clinician. Nurse The nurse deemed competent by Nursing Services to perform nursing duties in patient preparation and the administration of medication for procedural moderate sedation/analgesia Successful completion of conscious sedation training program is required. 6.3 The Patients 6.3.1 short anticipated rapid state. Conscious sedation is used only for patients undergoing diagnostic or therapeutic procedures with an recovery and return to pre- anesthetized 6.2.3

6.3.2 Patients undergo a clinically indicated diagnostic or therapeutic procedure is selected for conscious sedation require documentation and planning prior to the procedure. An assessment by an anaesthetist is required. 6.3.3 ensure Consultation to other specialties may be appropriate to adequate preparation.

6.3.4 Informed Consent.

The

provision

of

conscious

sedation

requires

an

Number: AHH-ANA-006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 4 of 15

6.3.5 Patients undergoing moderate sedation for elective procedures shall be on NPO. The NPO Criteria for patients undergoing Conscious Sedation are as follows: 6.3.5.1 Infants/Neonates (Birth to 1 Year of Age): Two hours for clear liquid Four hours for breast milk Six hours for solids and non-clear liquids 6.3.5.2 Children (>1 Year up to 12 years old ): Two hours for clear liquids Six hours for solids 6.3.5.3 Adults:(13 years and above) Two hours for clear liquids Six hours for a light meal, e.g., toast and clear fluids Eight hours for a meal of fried or fatty foods or meat 6.3.5.4 Variances In emergency situations or other situations where gastric emptying may be impaired, the potential for pulmonary aspiration of gastric content must be considered in determining the appropriate timing of the interventions as well as the degree of the sedation/analgesia.. Any variance from NPO criteria is to be justified by the clinician. 6.3.6 Patients should have their procedure and until the cardiorespiratory depression. 6.3.7 consciousness, receiving intravenous conscious sedation vascular access maintained throughout the patient is no longer at risk for

Monitoring requirements during procedural moderate sedation/analgesia include the patients level of oxygenation, ventilation and circulation.

Monitoring used should be American

appropriate to the patient's condition.

6.3.8 Patients are selected for conscious sedation based on The

Number: AHH-ANA-006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 5 of 15

Society of Anesthesiologists: guidelines for classifying a patients physical status. 6.4 ASA Physical Status Classification: The guidelines for classifying a patients physical status: Class I: a normally healthy patient with no systemic Class II: a patient with mild systemic disease. Class III: a patient with moderate to severe systemic limits activity but is not incapacitating Class IV: a patient with severe systemic disease that is and which is a constant threat to life. Class V: a moribund patient not expected to survive

6.4.1 disease. 6.4.2 6.4.3 disease that 6.4.4 incapacitating 6.4.5 more than 24

hours with or without an operation. 6.4.6 If the procedure is being done as an emergency, the letter E is 6.4.7 potential normal risk candidates for conscious sedation. Patients who are classed III or IV or exhibit factors associated with difficulty in airway management are considered at a higher risk for potential adverse outcome. These patients require additional consideration in planning for the proposed intervention. ASA Class IV patients require a consultation to Anesthesia Department, unless added to the numerical score Patients who are classed ASA I or II may be considered

patient is in critical care and airway is protected. 6.5 is administered: 6.5.1 manual sphygmonometer. 6.5.2 Pulse oximetry. Stethoscope and automated blood pressure monitor, or Equipments The following minimal equipment and supplies shall be present and ready for use in all areas where conscious sedation

Number: AHH-ANA-006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 6 of 15

6.5.3 Oxygen supply including piped (central or wall) oxygen or portable oxygen and a back up supply. Portable oxygen supply and back-up must each be the equivalent of at least a full type E cylinder. 6.5.4 Oxygen delivery system capable of providing an enriched oxygen concentration up to 100%. 6.5.5 Airway management equipment (appropriate size airway, bag-valvemask (BVM) device of proper size and fit for the patient), and emergency intubation equipment. 6.5.6 Reliable source of suction including Yankauer suction tip. 6.5.7 Intravenous supplies and medications including reversal agent or Antagonist medication, when appropriate. 6.5.8 Cardiac monitor for patients receiving procedural moderate sedation/analgesia using intravenous agents, and in patients with significant cardiovascular disease, or those who are undergoing procedures when dysrhythmias are anticipated. 6.5.9 Broselow Pediatric Emergency Tape.

6.5.10 in close proximity

Crash cart with defibrilltor must be available and

to the procedure/sedation site. 7.0 Procedures: The patients history and need for conscious sedation, prior to the receiving conscious sedation. The history includes:

7.1 patient

7.1.1 Any history of impaired cardiac, renal or hepatic function or other serious systemic disease (e.g., sickle cell disease, diabetes). 7.1.2 History of current medications. 7.1.3 Any allergic reactions to medications, with specific reference to sedatives, local anesthetics and contrast dyes, if applicable. 7.1.4 Any previous experience with conscious sedation or anesthesia. 7.2 For elective procedures using conscious sedation, a complete physical examination performed within two weeks prior to the procedure and documented in the patients medical record is acceptable, Physical examination and investigations must include:
Number: AHH-ANA-006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 7 of 15

7.2.1 Age and weight of all patients. 7.2.2 Vital signs (blood pressure, temperature, pulse). 7.2.3 ECG when appropriate 7.3 any of Considers consultation with an anesthesiologist if not familiar with The following: 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 Sickle cell disease. Family history of malignant pyrexia. Unstable cardiac status. Signs and symptoms of shock. Uncontrolled airway or respiratory in-sufficiency, except

in cases of bronchoscope. 7.3.6 Central nervous system depression. 7.3.7 Systemic disease, such as renal or hepatic failure 7.3.8 Patients who are pregnant and who are undergoing nongynecological procedures. 7.3.9 Patients who have been on monoamine oxidase inhibitor within the previous two weeks. 7.4 The qualified staff monitoring a patient who received medication shall have no or other responsibilities which would require that individual to leave the patient unattended which would compromise continuous patient monitoring during and after the procedure. The staff member may assist with minor interruptible tasks, provided continuous monitoring is not compromised. A qualified staff member can monitor, at the same time, a maximum of three patients who are recovering from procedural moderate sedation/analgesia. The patient must be within proximity and sight of the monitoring individual. 7.5 The nurse assigned to the conscious sedation procedure is responsible for the following: 7.5.1 Performing a pre-procedure assessment to provide baseline data which includes: Last oral intake. Temperature, blood pressure, heart rate and respirations.
Number: AHH-ANA-006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 8 of 15

7.5.2 respirations. 7.5.3 7.5.4 7.5.5 7.5.6 7.5.7 7.5.8 an IV 7.6 adverse

Temperature,

blood

pressure,

heart

rate

and

Oxygen saturation, with pulse oximeter. Skin color and condition. Drug allergies. Level of consciousness. Emotional state. Maintaining venous access (either a running infusion or lock) until patient is discharged.

Documentation concerning conscious sedation in accordance with drug events and reactions are available and implemented.

7.7 Monitoring requirements during procedural moderate sedation /analgesia include the patients level of consciousness, oxygenation, ventilation and circulation. Monitoring used should be appropriate to the patients condition 7.7.1 Following non-intravenous administration of medication, including oral, nasal, sublingual, rectal, inhalational or intra-muscular routes, minimal monitoring includes: continual sedation level or score, respiratory rate and ventilatory adequacy, pulse, blood pressure (BP) and continuous pulse oximetry. Monitoring continuous with documentation every 10 minutes until completion of the procedure and beginning of the recovery phase. The minimal interval for monitoring and documentation of BP in the Paediatric patient may be omitted during the actual procedure to avoid patient awakening and movement as clinically appropriate. 7.7.2 Following intravenous administration of medication, minimal monitoring includes: Continual sedation level or score, respiratory rate and ventilatory adequacy, pulse, blood Pressure and continuous cardiac rhythm and pulse oximetry. Monitoring shall be continuous with documentation every 5 minutes until completion of the procedure and beginning of the recovery phase. Clinical signs can estimate ventilatory adequacy or depth such as: 7.7.2.1 Observation of chest expansion.
Number: AHH-ANA-006 Original IssueDate:Nov. 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 9 of 15

shall be

7.7.2.2

Auscultation of breath sounds using pericardial or

parasternal stethoscope. 7.7.2.3 During recovery following the procedure, monitoring, including the assessment of pain, remains continuous with documentation a minimum of every fifteen (15) minutes to complete the first hour and then a minimum of every thirty (30) minutes thereafter until the patient qualifies for discharge or transfer. 7.8 an inPatient transferred or discharged 7.8.1 Patients receiving conscious sedation shall be transferred to patient unit in accordance with established criteria: 7.8.1.1 documented 7.8.1.2 baseline 7.8.1.3 on 7.8.1.4 7.8.2 discharge if all the room air. The performing clinician has written an order indicating patient is fit for transfer. receiving conscious sedation are following criteria are met: fit for Oxygen saturation (O2 Sat) is greater than 95% Level of consciousness has returned to baseline or sedation score *<2. Vital signs are stable (+/-20% of pre-sedation

Patients

7.8.2.1 Level of consciousness has returned to preprocedure sedation baseline or sedation score, score <2 with state of alertness and orientation appropriate for age. 7.8.2.2 Vital signs are stable (+/- 10% of preprocedure baseline). 7.8.2.3 Oxygen Saturation has returned to pre-procedure baseline. 7.8.2.4 Patient is active or ambulating where appropriate with minimal assistance. Patients pain (if present) <3 on pain score.
Number: AHH-ANA-006 Original IssueDate:Nov. 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 10 of 15

7.8.3

Criteria (1) through (5) are valid 1.5 to 2 hours following use

of a reversal depression 7.8.4 home or suitable Patient has a responsible individual to accompany alternate arrangements set in place. agent for over sedation or cardio-respiratory

7.8.5 Discharge orders have been written by the clinician. Ensuring that written discharge instructions are given and explained clearly to the patient or the caregiver. 7.8.6 Modified Aldrete score of 8 documents per procedure baseline score. Modified Aldrete Score
Activity: Able to 4 extremities move voluntarily or 2 extremities on command 0 extremities Respiration

2 1 0 Able to deep breath and cough 2 freely 1 Dyspnea, shallow or limited 0

breathing Apneic BP +/- 20mm of pre-anesthetic level BP +/- 20-50 mm of preanesthetic level BP +/- 50 mm of pre-anesthesia level Fully awake Arousable on calling Not responding

Circulation

2 1 0

Consciousness

2 1 0

O2 Saturation

Able to maintain O2 Saturation 2 >92% on room air Needs O2 inhalation to maintain 1 O2 saturation > 90% O2 saturation <90% even with O2 0 supplement

Number: AHH-ANA-006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 11 of 15

8.0

Medications: Anesthesiology director in collaboration with anesthesia and pharmacy recommends to the pharmacy & drug committee, the drugs to be added or deleted from the conscious sedation list of drugs. All medications for the purpose of procedural moderate sedation/analgesia shall be prescribed by the clinician, administered by qualified staff and, where appropriate, titrated for maximum effect. 8.1 Chloral Hydrate: 8.1.1 Dosage and rate of administration: Neonates: 50 mg/kg. Infants and children: 70 mg/kg. May repeat the dose once.

8.1.2 Precaution Comments / Stability 8.1.2.1 Not effective if vomiting. 8.1.2.2 Tastes bad, thus hard to give a large volume. Giving 510 cc water may prevent gagging and vomiting. 8.1.2.3 Problems with hypotension and respiratory depression. 8.1.2.4 Can cause severe hepatic or renal impairment, cardiac disease or porphyria, hypersensitivity or idiosyncratic reaction. 8.1.2.5 Avoid in patients in Phenytoin 8.1.2.6 Excessive or repetitive doses have been associated with cardiac arrhythmias. 8.1.2.7 Discourage use in pediatric patients more than 3 years of age, only use in infants and neonates. 8.2 Benzodiazipines : The majority of physicians are familiar with the work horses of conscious sedation benzodiazipines and narcotics. Other drug has commonly used but effective include Sedativeshypnotics, neuroleptics and anesthetics agents.

Number: AHH-ANA-006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 12 of 15

8.2.1

Diazepam (Valium) A lipid insoluble compound with a relatively fast onset action within 5 minutes but unpredictable duration of action its IV actions subside in 1 to 2 hours at dose of 0.07 to 0.15 mg./kg. IV. one can expect about 65 to 70% of patients to experience amnesia of events. It not be given IM due to local irritation. 8.2..2 Lorazepam (Ativan) It can be given sublingual PO, IM and IV. Intravenous has relative fast onset action within 5 minutes but has a longer duration of action up to 3 to 4 hours. At dose of 0.02 to 0.04 mg/kg I.V. one can expect about 75 to 85% of patients to experience amnesia. 8.2.3 Midazolam (Dormicum) It can be given SC, IM or IV or even PO in some situation it has ster onset of action- 2to 3 minutes without pain on injection and short duration of action. 1 to 2 hours doses for midazolam IV should be 0.02-to 0.04-mg./ kg. We prefer to give 2 mg. Every 2 to 3 minutes until a suitable level of sedation is reached or total dose of 0.1 mg/kg is reached. 9.3 with Narcotics - Opiates" Narcotics should be reserved for procedures associated not only anxiety but with pain.

9.3.1 Morphine: It has slight delay in its onset of action but also has a longer duration of action to its relatively hydrophilic nature. In a dose of 0.07-to 0.15 mg/kg one can expect an effect within 510 minutes and durationmore than 2 hours side effects: histamine release, emesis, and respiratory depression. 9.3.2 Meperidine (Pethidine) Has a slightly faster onset of action but a shorter duration. A dose range from 0.3 to 0.7-mg/kg results in onset of
Number: AHH-ANA-006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013

Number of Pages: 1 3 of 15

action less than 5 minutes and duration of about 1 to 2 hours. It cause less histamine release and nausea and morphine. 9.3.3 Fentanyl Sublimaze: It is a synthetic lipophylic with quicker onset and shorter duration of action, there is less histamine release and less emesis. Doses of 0.3 to 0.5 mcg/kg should be given followed by 0.1 mcg/kg until a adequate level of sedation is reached. One should not use more than 1 mcg/kg unless he is prepared to deal with airway consequences. Onset of action 2 to 5 minutes and duration up to 1 hour. It has cardio vascular stability. 9.3.4 Neuroleptic This is less commonly used. These can be particularly helpful in dealing with confused patients in whom we are concerned about respiratory depression from opiates. Two drugs are known haloperidol and droperidol. 9.4 The anesthetic induction agents : These are used by anesthetist in the operation theatre which includes: 9.4.1 Propofol (Diprivan), 9.4.2 Ketamine (Ketalar) 9.4.3 Sodium Thiopentone Pentothal 9.5 drugs that can help and potentially same patients. 9.5.1 Nalaxone (Narcan) As an opiate antagonist, for it to be effective, opiate should be use as a part of the conscious sedation. We start with 0.4 mg in 10cc syringe and administer 0.04 mg boluses every 2 to 4 minutes until desired effect is seen. A dose of 0.4 mg can result in side effects like a arrhythmia and pulmonary edema. The Physician during conscious sedation should be familiar with two

Number: AHH-ANA-006

Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 14 of 15

9.5.2 Flumazenil (Anexate) A benzodiazepines antagonist has a recommended dosage of 0.1 mg every 5 minutes up to three doses or in the unconscious patient 0.3mg every 5 minutes up to 3 doses. It is contraindicated to patients with history of seizure disorders. 10. 0 Reporting & Statistics: 10.1 Service chiefs whose staff use conscious sedation submit a semi-annual report to the medical director, identifying volume statistics for the use of conscious sedation and any complication encountered such as, hypersensitivity. 10.2 Statistics from use of conscious sedation are analyzed and the analyzed trends monitored and documented. The reports should be submitted to the Quality Management Department. Recommendation leading to improvement in practice is implemented. 11.0 Clinician Priviledging: 11.1 Privileges shall be sought and granted for medical staff whose scope of practice includes the use of conscious sedation (procedural moderate sedation/analgesia) in accordance with Credentials and Privileges Policies. 11.2. A list of privileged clinicians is kept in the Quality Management Office. 12.0 Attachment: 12.1 Operation Request Form 12.2 Pre Anesthesia Evaluation Record 12.3 Informed Consent Form

12.0 References: 12.1 Anaesthesia Policy and Procedure Number AHA-006, Issued November 2007. 12.2 Clinical Anaesthesia byG. Edward Mirgan,Jr. Maged S. Mikhail,Michael J. Murray,pp.196 12.3 Operating Room technique by Nancy Marie Phillips,pp. 196

Number: AHH-ANA 006 Original Issue Date:November 2007 Revision Date: June 2011 Effective Date: July 2011 Due for Revision: July 2013 Number of Pages: 15 of 15 13.0 Approval Section: Prepared by: _______________________________ Ms. Bella M. Samonte Clinical Quality Assurance Manager _______________________________ Ms. Marwa Del Castillo Anaesthesia Department Head Nurse Reviewed by : _______________________________ Ms. Pacita C. Frias Nursing Department Head _______________________________ Dr. Mohammad Askar Chief of Anaesthesia and Head of Operating Room Approved by : _______________________________ Dr. Abdulaziz Al Hammadi Vice-Director of Medical Affairs _______________________________ Dr. Reema Al Hammadi Director of Medical Affairs _______________________________ Mr. Mohammad Al Hammadi Executive Director _______________ Date _______________ Date _______________ Date _______________ Date _______________ Date _______________ Date _______________ Date