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Practical Procedures
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Research study
Subcutaneous dissociative conscious sedation outside the
operating theatre: prospective randomised double-blind study
Abstract
Introduction
Colonoscopy is among the common
diagnostic and therapeutic gastrointestinal interventions, which is
routinely done outside the operating
room. The painful nature of the procedure and patient anxiety resulting
from gas insufflation propose using
sedatives and analgesics during the
colonoscopy procedure. The goal of
this study is to compare the safety of
different methods of conscious sedation in remote location anaesthesia.
Materials and methods
Our prospective randomised doubleblind study was conducted among 90
adult patients who were scheduled
for elective colonoscopy. Patients
were randomly assigned to one of
the three groups: subcutaneous ketamine in conjunction with opioid,
propofol in conjunction with opioid
and midazolam in combination with
opioids. Extra doses of opioids were
administered on demand during the
procedure. Heart rate, blood pressure
and blood oxygen saturation were
measured throughout the procedure.
Adverse effects and recovery events
were recorded.
Results
All patients tolerated the colonoscopy
well. Three study groups were comparable with regard to heart rate, BP,
apnoea and blood oxygen saturation.
Pain score and opioid consumption
were significantly lower in ‘subcutaneous ketamine in conjunction with
opioid’ group. Patient cooperation
* Corresponding author
Email: [email protected]
Anesthesiology and Intensive care Unit,
Tehran University of Medical Sciences, Iran
and endoscopist satisfaction were
significantly higher in the ‘subcutaneous ketamine in conjunction with
opioid’ group. Recovery time was
comparable in three groups and all
patients experienced an uneventful
recovery.
Conclusion
Subcutaneous dissociative conscious
sedation, a recently reported method
of conscious sedation, provides
more safety and patient satisfaction
in comparison with conventional
methods. Subcutaneous ketamine
in conjunction with opioid could be
considered as a safe and efficient
method of conscious sedation in
remote location anaesthesia.
Introduction
Colonoscopy is an important and
common gastrointestinal therapeutic
and diagnostic intervention1, which
is performed outside the operating
theatre by endoscopists2. Despite
considerable improvement in gastrointestinal procedures, anaesthesia
in remote areas is not risk free
and patient safety is still the most
important concern outside operating theatre procedures. The pain
related to gas insufflation and patient
anxiety propose using sedatives and
analgesics during the colonoscopy
procedure. Endoscopists usually
prefer using intravenous (i.v.) sedation or even general anaesthesia to
achieve patient comfort and optimal
situation throughout the colonoscopy procedure3–4. In addition, most
patients undergoing gastrointestinal interventions are outpatients
and a short stay period in the postanaesthesia care unit (PACU) is
desirable4-7. Conventional regimens
including combination of benzodiazepines and opioids have been used
to provide analgesia and amnesia.
Using hypnotics in combination
with opioids improves the quality of
sedation and reduces probable side
effects3,8–18. Propofol has been recommended as a safe hypnotic drug in
colonoscopy while using appropriate
monitoring19–30.
Ketamine as an old anaesthetic,
with known effects of analgesia
and amnesia, has been used widely
via different routes of administration for inducing anaesthesia and
sedation15,31–34. Subcutaneous (s.c.)
dissociative conscious sedation
(sDCS), which is defined as using
sub-anaesthetic doses of s.c. ketamine in conjunction with narcotics,
has recently been reported by Javid
et al. as a safe and efficient method of
conscious anaesthesia and conscious
sedation36,38.
Considering the feasibility to
preserve spontaneous ventilation
and patient cooperation and considerable amnesia as prominent
characteristics of sDCS methods, we
decided to evaluate and compare the
efficiency of this method of conscious
sedation with conventional methods
in patients undergoing colonoscopy.
Materials and methods
This work conforms to the values laid
down in the Declaration of Helsinki
(1964). The protocol of this study has
been approved by the relevant ethical
committee related to our institution in which it was performed. All
subjects gave full informed consent
to participate in this study.
Patients and settings
Our prospective randomised doubleblind study was conducted on 90
patients scheduled for elective colonoscopy. Patients were informed
Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)
F
: Javid MJ, Karvandian K, Shàbani S, Zebardast J. Subcutaneous dissociative conscious sedation
outside the operating theatre: prospective randomised double-blind study. OA Anaesthetics 2013 Mar 01;1(1):4.
CompeƟng interests: none declared. Conflict of Interests: none declared.
All authors contributed to the concepƟon, design, and preparaƟon of the manuscript, as well as read and approved the final manuscript.
All authors abide by the AssociaƟon for Medical Ethics (AME) ethical rules of disclosure.
MJ Javid, K Karvandian, S Sha`bani*, J Zebardast
Page 2 of 5
about the possible risks and benefits
of the study and a written consent
was received from the patients.
Anaesthetic method
Patients were randomly assigned
to one of the three groups; s.c. ketamine in conjunction with opioid
(sDCS), propofol in conjunction
with opioid and benzodiazepines
in conjunction with opioids. Extra
doses of opioids were administered
on demand during the procedure.
Heart rate, blood pressure (BP) and
blood oxygen saturation (SpO2) were
measured throughout the procedure.
Adverse effects and recovery events
were recorded.
Patient with American Society of
Anesthesiologists class III and IV,
cardiovascular disease, hypertension, history of drug abuse, history
of hypersensitivity to medications,
and any cognitive disorders were
excluded from the study.
Patients were continuously monitored using standard techniques
including electrocardiography, pulse
oximetry and non-invasive sphygmomanometry.
All procedures were performed
out of the operating room and by the
same endoscopist.
All patients were administered (i.v.)
meperidine 0.5 mg/kg and i.v. fentanyl
1µg/kg. Then, they were randomly
assigned to receive s.c. ketamine
0.6 mg/kg (sDCS group), infusion of
propofol 50 µg/kg/min (propofol
group) and midazolam 0.015 mg/
kg (midazolam group) at least 5 min
before starting the procedure when
the desirable level of conscious sedation had been achieved. The site of
s.c. injection in all patients was on the
anterior side of the forearm.
An extra dose of i.v. fentanyl 1 µg/
kg to maximum dose of 3 µg/kg, and
in the case of inefficient sedation an
additional dose of pethedine 0.5 mg/
kg was administered.
During the procedure, heart rate
and BP were recorded at 5-min intervals. Continuous monitoring of SpO2
and echocardiogram was established
throughout the procedure.
Adverse events, such as apnoea,
desaturation, hypotension, bradycardia, needed immediate intervention, and patient movements
resulting from pain or agitation were
recorded.
Patients received supplemental
oxygen by face mask. Desaturation
(SpO2 < 90) was recovered by jaw
trust and head tilt manoeuvre. Mask
ventilation devices were available to
interfere with probable apnoea.
The period of recovery (the time
needed for patients to become fully
awake and obedient) was recorded.
A duration of 20 min was considered as normal recovery time and
more than this defined as prolonged
recovery.
At the end of the recovery, patients
were asked about experiencing pain
or discomfort during the procedure
and satisfaction with their sedation.
Also any event of nausea, vomiting,
vertigo, visual disturbance and
hallucination during the procedure
and recovery period was recorded.
At the end of procedure, the
endoscopist was asked about his
satisfaction with the quality of sedation concerning the feasibility of the
procedure case by case.
Statistical analysis
Data were recorded through a questionnaire form. Statistical calculations were performed using SPSS
software, version i8.0 and analysed
by Student’s t -test and two-tailed
Fisher test. Differences were considered significant at P < 0.05.
Results
All patients tolerated the colonoscopy well. No patient was excluded
from the study. Mean age in the study
group was 33.00 ± 7.64 years, and
56% of the patients were men. No
significant demographic differences
were observed between the study
groups.
Three groups were comparable
with regard to heart rate and BP.
Haemodynamic changes, more than
20%, was detected in one case in
group sDCS (3.3%), no case in group
propofol and three cases in group
midazolam (10.0%) (P = 0.160).
No event of SpO2 < 90% in sDCS
group was recorded. Four patients
in propofol group (13.3%) and one
patient in midazolam group (3.3%)
showed desaturation (P = 0.064)
that was statistically non-significant.
Pain score and opioid consumption were significantly lower in sDCS
group. Two patients experienced
pain in sDCS group (6.6%), eight
patients in group propofol group
(26.6%), and 12 patients in group
midazolam group (40%) (P = 0.010).
One patient in group sDCS (3.3%), 10
patients in group propofol (33.3%)
and 11 patients (36.6%) in group
midazolam needed additional doses
of fentanyl (P = 0.040).
No patient in group sDCS needed
additional dose of meperidine. Seven
patients (23.3%) in group propofol
and nine patients (30.0%) in group
midazolam received additional dose
of meperidine (P = 0.006).
Patient cooperation and endoscopist satisfaction were significantly higher in sDCS group. Patients
were completely satisfied with their
anaesthesia in group sDCS and
propofol and no recall was reported
by the patients. In group midazolam,
17 patients (56.6%) were not satisfied with their sedation and recall
was reported by all 17 patients (P =
0.001).
A 93.3% (28 cases) satisfaction was
reported by the endoscopist in sDCS
group, 70.0% (21 cases) in group
propofol and 33.3% (10 patients) in
group midazolam (P = 0.001).
Recovery time was comparable in
all three groups and all patients experienced uneventful recovery.
The duration of recovery more
than 20 min was detected in two
cases in sDCS group (10.0%), five
cases in propofol group (16.6%),
and eight cases in midazolam group
(26.6%) (P = 0.115), which was not
statistically significant (Table 1).
Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)
F
: Javid MJ, Karvandian K, Shàbani S, Zebardast J. Subcutaneous dissociative conscious sedation
outside the operating theatre: prospective randomised double-blind study. OA Anaesthetics 2013 Mar 01;1(1):4.
CompeƟng interests: none declared. Conflict of interests: none declared.
All authors contributed to the concepƟon, design, and preparaƟon of the manuscript, as well as read and approved the final manuscript.
All authors abide by the AssociaƟon for Medical Ethics (AME) ethical rules of disclosure.
Research study
Page 3 of 5
Discussion
Colonoscopy is an important,
common gastrointestinal therapeutic
and diagnostic intervention1, which
is performed outside the operating
theatre by endoscopists2. Despite
considerable improvement in gastrointestinal procedures, this is still a
high-risk area for outpatient procedures.
Patient anxiety and pain related to
gas insufflation propose using sedatives and analgesics during the colonoscopy procedure. Endoscopists
usually prefer using i.v. sedation or
even general anaesthesia to achieve
patient comfort and optimal situation to prevent failure of the procedure1–4. In addition, most patients
undergoing gastrointestinal interventions are outpatients and a
short PACU admission period is
desirable4–7. Conventional regimens
including a combination of benzodiazepines and opioids have been used
to provide analgesia and amnesia.
Using hypnotics in combination with
opioids improves the quality of sedation and reduces probable complications3,8,18. Propofol has been recommended as a safe hypnotic drug in
colonoscopy19–30. It is a hypnotic
agent with rapid onset and short
duration of action, and it is preferred
for sedation in procedures with short
duration15. One of the most important side effects of propofol is respiratory depression, and some studies
demonstrated high end-tidal CO2
levels in deep sedation with propofol.
Therefore, it is recommended that
this agent should be administered
with appropriate monitoring by an
anaesthesiologist25–30.
Given the characteristics of remote
location procedures (outside operating theatre), choosing an appropriate method of anaesthesia or
analgesia with the least risk of
haemodynamic changes and respiratory depression is a priority.
Ketamine is an old anaesthetic
with known effects of analgesia and
amnesia and has been widely used
by different routes of administration for inducing anaesthesia and
sedation15,31–38.
Intact airway protective reflexes
and lack of respiratory depression
are unique characteristics of the
drug14. This agent has been administered widely as a solitary sedative
agent or in combination with opioids
and benzodiazepines4,31–38.
Table 1. Incidence of recorded parameters.
Variable
DesaturaƟon
Pain
AddiƟonal fentanyl
AddiƟonal meperidine
Increased HR and BP >20%
CooperaƟon in posiƟoning
Nausea
VomiƟng
Recall
PaƟent’s saƟsfacƟon
Endoscopist’s saƟsfacƟon
Prolonged recovery
BP: blood pressure
HR: heart rate.
Group
sDCS (%)
0.0
6.6
3.3
0.0
3.3
100.0
20.0
13.3
0.0
100.0
93.3
10.0
Group
Propofol
(%)
13.3
26.6
33.3
23.3
0.0
33.3
6.6
6.6
0.0
100.0
70.0
16.6
Group
Midazolam (%)
3.3
40.0
36.6
30.0
10.0
96.6
23.3
16.6
56.6
43.3
23.3
26.6
P value
0.064
0.010
0.040
0.006
0.160
0.001
0.372
0.484
0.001
0.001
0.001
0.115
sDCS using s.c. injection of subanaesthetic doses of ketamine in
conjunction with narcotics has
recently been reported by Javid et
al. as a safe and efficient method of
conscious anaesthesia and conscious
sedation36,38.
It was successfully used as an
alternative to general anaesthesia in
laparoscopic peritoneal dialysis catheter implantation36,38.
By keeping the plasma concentration of ketamine at or below 150 ng/
ml there was no risk of hallucination,
adverse cardiovascular effects and
airway hypersecretion36,38.
Considering the feasibility to
preserve spontaneous ventilation,
patient co-operation and considerable amnesia as prominent characteristics of the sDCS method, we
decided to evaluate and compare the
efficiency of this method of conscious
sedation with conventional methods
in patients undergoing colonoscopy.
This study shows that dissociative
conscious sedation (use of s.c. injection of low-dose ketamine in conjunction with narcotics to achieve an
acceptable level of sedation, pain relief
and amnesia) is an effective method
for procedures outside the operating
theatre. Patients remain considerably co-operative and obedient, but
are sufficiently sedated and pain-free.
Besides, the study shows that s.c.
administration of ketamine provides
efficient conscious sedation accompanied by a significantly lower pain
score, opioid consumption and recall
rate and higher rate of patient and
endoscopist satisfaction. This might
be because of the increased analgesic
effect of opioids when they are used
in combination with ketamine (sDCS
method)36,38. No significant cardiovascular side effect of ketamine was
observed. These findings were similar
to the previous experiences of sDCS in
other procedures36,38.
The limitation of this study was
lack of EtpCO2 monitoring because
the side stream capnograph device
was not available in the colonoscopy
department.
Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)
F
: Javid MJ, Karvandian K, Shàbani S, Zebardast J. Subcutaneous dissociative conscious sedation
outside the operating theatre: prospective randomised double-blind study. OA Anaesthetics 2013 Mar 01;1(1):4.
CompeƟng interests: none declared. Conflict of Interests: none declared.
All authors contributed to the concepƟon, design, and preparaƟon of the manuscript, as well as read and approved the final manuscript.
All authors abide by the AssociaƟon for Medical Ethics (AME) ethical rules of disclosure.
Research study
Page 4 of 5
Conclusion
sDCS, a recently reported method of
conscious sedation, provides more
safety and patient satisfaction for
anaesthesia outside the operating
theatre in comparison with conventional methods.
sDCS could be considered as a safe
and efficient method of conscious
sedation in remote location anaesthesia.
Acknowledgement
This study was supported by research
centre of School of Medicine, Tehran
University of Medical Sciences.
Abbreviations list
BP, blood pressure; i.v., intravenous;
PACU, post-anaesthesia care unit; s.c.,
subcutaneous; sDCS, subcutaneous
dissociative conscious sedation;
SpO2, blood oxygen saturation
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Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)
F
: Javid MJ, Karvandian K, Shàbani S, Zebardast J. Subcutaneous dissociative conscious sedation
outside the operating theatre: prospective randomised double-blind study. OA Anaesthetics 2013 Mar 01;1(1):4.
CompeƟng interests: none declared. Conflict of interests: none declared.
All authors contributed to the concepƟon, design, and preparaƟon of the manuscript, as well as read and approved the final manuscript.
All authors abide by the AssociaƟon for Medical Ethics (AME) ethical rules of disclosure.
Research study
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Licensee OA Publishing London 2013. Creative Commons Attribution Licence (CC-BY)
F
: Javid MJ, Karvandian K, Shàbani S, Zebardast J. Subcutaneous dissociative conscious sedation
outside the operating theatre: prospective randomised double-blind study. OA Anaesthetics 2013 Mar 01;1(1):4.
CompeƟng interests: none declared. Conflict of Interests: none declared.
All authors contributed to the concepƟon, design, and preparaƟon of the manuscript, as well as read and approved the final manuscript.
All authors abide by the AssociaƟon for Medical Ethics (AME) ethical rules of disclosure.
Research study