Procedural Sedation

Procedural sedation is defined as - the technique of

administering sedatives or dissociative agents with or
without analgesic to induce an altered state of
consciousness that allows the patient to tolerate painful
or unpleasant procedures while preserving
cardiorespiratory function. Regardless of the
medication, dose or route of administration, when a
medication is used for the purpose of altering the
patient’s cognitive state in order to facilitate a specific
procedure, it is considered procedural sedation.

Procedural sedation is often performed in many areas

of the hospital outside of the operating theatre.
Because procedural sedation, like anaesthesia, poses
significant potential risks to patients, administration of
procedural sedation must be uniform throughout the
hospital. The qualification of staff participating in the
procedure, the medical equipment, the supplies and
the monitoring must be the same wherever procedural
sedation is provided in the hospital.
Joint commission international accreditation standards
for hospitals, 7th edition.

Policy on use of conscious sedation

The hospital maintains a uniform process for
administration of conscious sedation throughout its
premise.
The clinician performing the procedure shall plan to
sedate the patients based on patients’ age, pre
procedure vitals and other clinical details.

Purpose:
To provide guidelines for monitoring intravenous
sedation administered to patients undergoing invasive,
manipulative or diagnostic procedures or patients
admitted with mechanical ventilations in ICU etc.
To standardize the process of administration of sedation
(minimal, moderate and deep) throughout the hospital.
To ensure that Sedation of patient will be administered
by qualified and trained medical staff.
To ensure that the emergency medical technology and
supplies are available at the time where sedation is
being performed

Scope:
Sedation may be administered in the following
departments:
Endoscopy/ Bronchoscopy
Cardiac Cath lab
Intensive care units
Imaging Services -CT/MRI/ Nuclear medicine
Radiation Oncology

Responsibilities:
Primary — Anesthetists & doctors performing the
procedure
Secondary — Nurses & technicians

Definitions:
Minimal Sedation (anxiolysis)
A drug-induced state during which patients respond
normally to verbal commands. Although cognitive
function and coordination may be impaired, ventilation
and cardiovascular functions are unaffected.

Moderate sedation/ analgesia (conscious sedation)

A drug-induced depression of consciousness during
which patients respond purposefully to verbal
commands, either alone or accompanied by tactile
stimulation. No interventions are required to maintain a
patent airway, and spontaneous ventilation is
adequate. Cardiovascular function is usually
maintained.
Deep sedation/analgesia
A drug-induced depression of consciousness during
which patients 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.

Goals:
Procedures are done under Sedation:
To guard the patient’s safety and welfare
To minimize physical discomfort, pain, or anxiety
To minimize negative psychological responses to
treatment by providing sedation and analgesia, and to
maximize the potential for amnesia
To control behaviour in some children and
uncooperative adults, to expedite the Conduct of
procedures which are not particularly uncomfortable,
but which require the patient not to move,
To return the patient to a state in which safe discharge,
as determined by recognized criteria is possible for
outpatients or to return inpatients to pre -sedation
status.
Staff competency :
Only qualified and privileged medical professionals are
authorized for performing procedural sedation and
monitor patients receiving sedation
Individuals responsible for performing procedure should
be different than the individuals administering
procedural sedation and monitor patients receiving
sedation
Medical professionals responsible for administering
minimal/moderate sedation are competent in:
Techniques and various modes of sedation
Pharmacology of sedation drugs and the use of reversal agents
( Flumazenil for over dosage of midazolam and naloxone for
over dosage of opoids)
To predictably achieve desired levels of sedation in the patient
and to
monitor patients carefully in order to maintain them at the
desired level of sedation.
Evaluation of patients prior to performing minimal & moderate
sedation
Responding to complication of procedural sedation both during
and after sedation
Competent in methods and techniques required to rescue those
who unavoidably/Unintentionally slip into a deeper-than-desired
level of sedation or analgesia using reversal agents.
To manage an unstable cardiovascular system as well as a
compromised airway and inadequate oxygenation and
ventilation.
Healthcare professionals are privileged to administer
minimal & moderate sedation which is to be duly
mentioned in their respective privileging forms kept in
their personnel files
Healthcare professionals responsible for supervising
and providing uninterrupted monitoring of patients
during moderate/deep sedation must be competent in:
Knowledge on pharmacology of sedative agents/medications.
Assessing total patient care during minimal/moderate sedation
Monitor respiratory rate, oxygen saturation, blood pressure,
cardiac rate and rhythm, and patient's level of consciousness.
Anticipate and recognize potential complications of IV
conscious sedation in relation to the type of medication being
administered
Possess the requisite knowledge and skills to assess, diagnose
and intervene in event of complications or undesired outcomes
Airway management resuscitation
Use of reversal agents
Recovery criteria
Trained in performing age appropriate BLS/ACLS.

Equipment and Monitoring

Equipment and supplies appropriate for the size of the
child or adult being sedated, must be secured, checked,
and with immediate access to patient (bedside, exam
table, etc.) before sedation and analgesia are given.
Appropriate equipment for montoring shall be available
for monitoring vital signs including heart and
respiratory rates and Oxygenation using pulse oximetry
equipment
Minimum Equipment required are:
Basic and advanced airway management equipment
IV equipment appropriate to size and supplies including
syringes
Pulse oximeter with alarm (oxygen saturation)
Operating wall O2 source with a flow meter or a full portable O2
tank
Positive pressure oxygen delivery device (bag-valve-mask) such
as Ambu bag:
Suction source, with regulator (wall or portable), and suction
catheters.
Cardiac and Blood pressure monitoring system (manual or
automatic).
The following items must be immediately accessible:
Emergency medications
Epinephrine
Atropine
Lidocaine
Pharmacologic antagonists like Flumazenil and Naloxone are available

A portable cardiac monitor and defibrillator with cardioversion

capabilities

Heart rate and oxygenation shall be continuously

monitored by pulse oximeters.
Respiratory frequency and adequacy of pulmonary
ventilation shall be continually monitored
Blood pressure shall be measured at regular intervals.
ECG shall be monitored in patients with significant
cardiovascular disease or when dysthymias are
anticipated or detected.
The monitoring shall be documented in procedure form
under sedation

Procedure
1. Consultant writes the orders for the procedure in progress
notes for IPD patients and on OPD prescription in case of
procedures to be done in OPD.
2. Separate consents will be taken — one each for sedation and
procedure
3. Consent for sedation shall be taken by Anesthetist after
discussing/educating the patient about the proposed sedation,
potential benefits and drawbacks, possible alternatives, the
likelihood of success, possible problems related to recovery and
the possible results of non-treatment. This education is to be
given to the patient/his or her family/those who are authorized
to make decision for the patient (refer policy on Informed
Consent).
4. The physician performing the medical or surgical procedure
on the patient is responsible for obtaining the patient’s
informed consent for the procedure before starting the
procedure.
5. The Anesthetist / privileged consultants shall order the
pharmacological agent to be administered for sedation. An
anesthesiologist shall be available 24 hours a day for
consultation as needed.
6. All patients must have an intravenous access secured prior
to administration of moderate and deep sedation. Children may
receive only Syp. Trichlophos (pedichloryl) up to a dose of 50
mg/kg or oral midazolam in a dose of 0.3 mg- 0.5 mg/kg . Other
routes of administration and dosages are shown in the table
below: Common Drugs for Sedation (Non OT settings- except
ICU) for minimal moderate (conscious sedation) sedation

XXXXXXXXXX
** Infants 1 to 5 months: Limited data available in non-
intubated infants; infants <6 months are at higher risk
for airway obstruction and hypoventilation; titrate dose
with small increments to desired clinical effect; monitor
carefully.

Process flow for procedure under sedation

Indoor patient:
Patient in the WARD/ICU/HDU advised for procedure
under sedation
procedure Consent is taken by the Respective
consultant and Sedation consent by
anesthetist/intensivist
patient is shifted to the procedure department / area as
indicated
Outdoor patient:
OPD Patient advised for the procedure under sedation
(Bronchoscopy/Endoscopy/CT/MRI under sedation/etc)
anesthetist/intensivist is informed
procedure Consent is taken by the Respective
consultant and Sedation consent by
anesthetist/intensivist
patient is shifted to the procedure department / area as
indicated

Common tasks:
Pre, intra & post sedation assessment, is done by
anesthetist /Intensivist
Procedure notes are filled by consultant
After procedure the patient is shifted to recovery for 2
hours monitoring under the supervision of
anesthetist/intensivist
Patient is discharged from recovery after meeting the
discharge/recovery criteria

Evaluation, Monitoring and Documentation

All patients requiring sedation will have a pre procedure
assessment, intra procedure and post procedure
monitoring. It will be recorded in procedure form under
sedation
Pre-procedure evaluation and assessment includes:
History of Pre-Anesthesia/surgery
Pre sedation airway assessment (identify any airway problems
that may influence the type of sedation used)
Current medications, including any allergies
Systemic Examination
Clinical Evaluations
Fasting Period

Fasting guidelines

Ingested Material Minimum Fasting Period

Clear Liquids (non-alcoholic) 2 hrs

Breast Milk 4 hrs

Infant Formula 6 hrs

Non-Human Milk 6 hrs

Light meals 6 hrs

*Additional fasting time of 8 or more hours may be needed in
cases of patient intake of fried foods, fatty foods or meat

Evaluate at-risk patients for appropriateness of

procedural sedation
Depending on the anxiety levels of the patient,
assessment findings and type of procedure to be
performed, a sedation plan (outlining the type and level
of sedation) will be decided for the patient
Proper consent forms signed.
Safely administer sedation and interpret findings from
patient monitoring during procedural sedation and
recovery

Monitoring During Procedure

Monitoring of the patient is to be performed by a
person other than who is performing the procedure i.e.
Anesthetist and will include documentation of of vital
signs
Heart rate
Blood pressure
Respiratory rate
10.2.4 Oxygen saturation

The above documentation needs to be done

Prior to initiation of sedation.
Reviewed Every 10 minutes (minimum)
After Completion of Procedure

If maximum drug dosage is exceeded, the reason

should be documented by the physician

Sedation of Patients in ICU:

Following procedures are done under sedation in ICU
Endoscopy/Bronchoscopy
Percutaneous Tracheostomy
ECMO (Extra-corporeal membrane oxygenation)
All patients admitted in ICU will be sedated in such a manner
that will
Enable tolerance of endotracheal Intubation.
Enable tolerance of mechanical ventilation.
Enable pain relief in such a way that they are calm and yet arousable
Ensure that the patient is not aware of any procedures done.

Rescue of a patient from deeper level of

sedation:
Rescue of a patient from deeper level of sedation than
intended is an intervention performed by a clinician
proficient in airway management and advanced life
support.
The qualified practitioner corrects adverse physiologic
consequences of the deeper-than-intended level of
sedation (such as hypoventilation, hypoxia and
hypotension) returns the patient to the originally
intended level of sedation.

Post procedure Assessment

Post procedure documentation must include:
Heart rate
Blood pressure
Respiratory rate
Oxygen saturation

Post procedure observation must occur in a suitable

location.
Monitoring and documentation will continue every 15
minutes for a minimum of 2 hour. If discharged the
patient or responsible person must be provided verbal
and written instruction regarding diet, medications,
activities, and signs or symptoms of complications with
course of action to take if any complication develops.

Transfer/transport
A patient recovering from sedation and analgesia may
be transferred to another unit prior to discharge criteria
(as mentioned in the Procedure form under sedation
being met, and the unit receiving the patient provides
the same level of post procedure care monitoring, and
arrangements have been made with the nursing staff.
Handover is given to the nursing staff of the recovery
area. It includes:
All significant complications which occurred during or following
the sedation
Pre-sedation medical history
Sedation administered
Observed side effects or complications
Use of any pharmacologic antagonists.

Discharge:
Patient shall be discharged from the recovery room by
the qualified Anesthetist as per the discharge criteria.
(Modified Aldrete Scale). Aldrete Score ≥ 9 is fit for
discharge.
If discharge criteria are not met in 2 hours, the
physician shall be notified. The
anesthesiologist must reassess the patient and
determine appropriate action.
Discharge instructions shall be given and documented.
Outpatients shall be discharged with responsible adult
who shall accompany them from the hospital.
Outcomes of patients undergoing moderate/ deep
sedation are collected and analyzed in the aggregate in
order to identify opportunities to improve care.

In case of any complication notify the Consultant,

document complications and complete a hospital
incident report for the following:
Hemodynamic instability - Pulse, B.P. and SPO2
PONV - Post Operative Nausea Vomiting
Pain
Restlessness
Signs and symptoms suggesting respiratory distress or airway
impairment
Signs and symptoms suggesting pharmacologic overdose, and
Signs and symptoms suggesting unexpected drug effect.

Quality Monitoring/Outcomes:
Key aspects of moderate sedation/analgesia are monitored to
improve outcomes and compliance to standards.
Following indicator is tracked to monitor sedation services:
Percentage of adverse sedation events
The adverse events related to Sedation are recorded & flagged
to the treating physician in the incident form for RCA/CAPA