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bronchoscopy
Patient Satisfaction With Conscious
Sedation for Bronchoscopy*
Stefano Putinati, MD; Licia Ballerin, MD; Lorenzo Corbetta, MD;
Lucio Trevisani, MD; and Alfredo Potena, MD
Study objective: Bronchoscopic technique is not standardized. Controversies exist with regard to
premedication with sedatives before the test. To evaluate safety and efficacy of conscious
sedation, we studied 100 randomized patients undergoing diagnostic bronchoscopy; patients
received premedication with lidocaine spray and atropine sulfate IM (nonsedation group; 50
patients) or lidocaine spray, atropine IM and diazepam IV (sedation group; 50 patients).
Methods and results: Monitoring during flexible fiberoptic bronchoscopy included continuous
ECG and pulse oximetry. The procedure could not be completed in six patients. None received
premedication with diazepam; among the patients who ended the examination, tolerance to the
examination (visual analogue scale, 0 to 100; 0 5 excellent; 100 5 unbearable) was better in the
sedation group. Low anxiety, male sex, but not age were also associated with improved patient
tolerance to the test. Oxygen desaturation occurred in 17% of patients, and it was not more
frequent after diazepam treatment.
Conclusions: In our study, sedation had a beneficial effect on patient tolerance and rarely
induced significant alterations in cardiorespiratory monitoring parameters.
(CHEST 1999; 115:1437–1440)
Key words: fiberoptic bronchoscopy; intravenous diazepam; premedication; sedation
Abbreviations: FFB 5 flexible fiberoptic bronchoscopy; HR 5 heart rate; Spo2 5 oxygen saturation by pulse oxyimeter;
VAS 5 visual analogue scale
premedication before flexible fiberoptic
P atient
bronchoscopy (FFB) is variable, depending on the
personal experience of individual operators. Most bronchoscopists administer sedative drugs before FFB in
the conviction that a patient’s comfort might improve.1–3 The preferred sedative drugs are opioids and
benzodiazepines, alone or in combination, but some
bronchoscopists use more complex therapeutic regimens.3,4 However, there are potential complications
with the routine use of sedative drugs. Up to half of the
major life-threatening complications of FFB have been
related to sedative drug regimens.1,5,6 Nevertheless,
other authors think that many of these complications
*From the Divisione di Fisiopatologia Respiratoria (Drs. Putinati,
Ballerin, Corbetta, and Potena) and the First Divisione di
Medicina Generale (Dr. Trevisani), Arcispedale S. Anna, Ferrara,
Italy.
Manuscript received March 31, 1998; revision accepted November 24, 1998.
Correspondence to: Stefano Putinati, MD, Divisione di Fisiopatologia Respiratoria, Arcispedale S. Anna C.so Giovecca 203,
44100 Ferrara, Italy
could be ascribed to inadequate resuscitation equipment availability, to the failure in giving supplemental
oxygen, or to the use of opioids in combination with
benzodiazepines, which reduces the drug safety.7 Nowadays, risk-benefit considerations have become important because routine diagnostic FFB can also be performed adequately without any sedation.8 –10 During
FFB, conscious sedation would be justified by a significant improvement in a patient’s tolerance, outweighing
sedation-related risks. To evaluate this problem, we
performed a prospective, randomized, open study to
verify the effect of conscious sedation with diazepam on
a patient’s tolerance and cardiorespiratory parameters
during routine diagnostic FFB.
Materials and Methods
Patients
One hundred patients, undergoing a routine diagnostic FFB
for the first time, were evaluated. Patients undergoing BAL and
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transbronchial biopsy, as well as intubated patients, were excluded from the study. Fifty-four bronchoscopies were performed on an outpatient basis; the other 46 patients underwent
bronchoscopy during hospitalization. Each patient provided informed and written consent to bronchoscopy and was randomly
allocated to either the group examined with sedation or without
sedation.
Procedure
Before examination, patients performed FVC and FEV1 maneuvers and were asked to evaluate their subjective “fear” about
the procedure. Answers were given on a 100-mm visual analogue
scale (VAS), which was rated from 0 (not at all) to 100 (enormously), as previously described.11 Thirty minutes before FFB,
each patient received atropine sulfate (0.5 mg IM). Topical
anesthesia was achieved by giving 2% lidocaine solution in all the
subjects under study. First, lidocaine was sprayed to the nasopharynx, and then it was administered through the bronchoscope
onto the vocal cords and tracheobronchial tree, using 2-mL
aliquots. A total of 300 mg of 2% lidocaine solution was given to
each subject. Immediately before FFB, the sedation group
received small boluses of diazepam IV, slowly injected over
several minutes and until they became drowsy; this corresponded
to a mental alertness-drowsiness index of 3.12 The dose of
diazepam varied between 5 and 15 mg.
A single pulmonologist, who was not blinded about the allocation of patients to one of the two groups, performed all of the
FFBs transnasally, with the patients in supine position and using
an FFB (Olympus BF 1T 20 D; Olympus; Tokyo, Japan). During
the procedure, the heart rate (HR), ECG (Kontron Trakmon
7222; Watford; Herts, UK), and pulse oximetry (Minolta Pulsox-8; Minolta; Toyokama, Japan) were monitored. Supplemental
oxygen was administered by nasal cannula if the oxygen saturation
by pulse oximeter (Spo2) decreased below 90%. In case the
procedure was not well tolerated (more than two unsuccessful
attempts to introduce the bronchoscope and/or vigorous defense
reactions), the procedure was considered a failure and immediately suspended. After FFB, both the investigator and the
patients who did not receive diazepam assessed the global
tolerance score to the examination on VAS (0 5 no bother,
100 5 intolerable), as well as five specific sensations, such as ease
of introduction (0 5 very easy; 100 5 extremely difficult), vomiting, asphyxia, cough, and pain (0 5 nonexistent; 100 5 unbearable). Three hours after FFB with sedation, patients completed a
questionnaire on their tolerance to the procedure. Outpatients
were discharged home with a companion and were warned about
side effects of sedation on mental performance, and advised not
to drive for 24 h. The tolerance score was defined as the
arithmetic mean of global tolerance and the mean of the five
above-mentioned specific sensations. High scores indicated an
unfavorable response.
Statistics
Statistical analyses was carried out by the x2 test and the
Student’s t test. The impact of sedation, age, sex, and prebronchoscopy anxiety score on the main variable of patient’s tolerance
was evaluated by multiple regression analysis. Results were
considered significant if p values were , 0.05.
Results
There were no significant differences between the
two groups in terms of age, sex, smoking status,
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indications for bronchoscopy, FEV1 (percent of the
predicted one), and FVC values (percent of the
predicted one) (Table 1). Bronchoscopic procedures
carried out were similar in both groups, including
endobronchial biopsies and/or brushings in 28% and
32% in the sedation and nonsedation groups, respectively. Anxiety score before FFB, as judged on VAS,
was 40.57 6 30.16 in the sedation group and
40.63 6 30.10 in the nonsedation group (p 5 not
significant). All FFBs performed under sedation
were completed, while six procedures (12%) performed without sedation failed because of patient
intolerance (p , 0.05); there was no difference in
the two groups between inpatients and outpatients.
Among the six patients who failed to complete the
procedure, four were outpatients and two were
inpatients. By comparing only patients in whom the
FFB was fully completed, the tolerance score attributed by the patients was better in the sedation group
than in the nonsedation group (14.75 6 11.71 vs
22.86 6 14.64, p , 0.05). The tolerance score attributed by the bronchoscopist was not significantly
different in the two groups. However, it was significantly less than the score attributed by the patients,
both in the sedation group (11.83 6 7.99 vs
14.75 6 11.71, p , 0.05) and in the nonsedation
group (13.95 6 10.13 vs 22.86 6 14.64, p , 0.001).
Multiple regression analysis showed that FFB was
better tolerated in male patients (p , 0.05), in patients with less pre-FFB anxiety score, and in the
sedation group (p , 0.01).
By comparing the pre-FFB cardiorespiratory parameters with those taken during FFB, there was a
significant fall in Spo2 (from 96.1 6 1.9% to
90.5 6 4.8%, p , 0.001 in the sedation group, and
from 96.8 6 1.6% to 92.5 6 5.2%, p , 0.001 in the
nonsedation group), and a significant rise in HR
(from 79.6 6 14.9 beats/min to 104.6 6 20.8 beats/
Table 1—Patient Characteristics
Male/female
Age, yr*
Inpatients, yes/no
Smoking, yes/no
FEV1, % predicted*
FVC, % predicted*
Duration of FFB, min*
Indication for FFB
Cancer
Infiltrates
Hemoptysis
Other
Sedation
(n 5 50)
Nonsedation
(n 5 50)
41/9
61 6 13
21/29
38/12
80.4 6 17.9
90.2 6 18.4
7.5 6 2.8
38/12
62 6 12
25/25
42/8
84.5 6 21.2
94.4 6 20.1
7.7 6 2.3
25
14
7
4
26
13
7
4
*Mean 6 SD.
Bronchoscopy
min, p , 0.001 in the sedation group, and from
80.2 6 14.8 beats/min to 110.2 6 21.3 beats/min,
p , 0.001 in the nonsedation group). However, the
fall in Spo2 and the increase in the mean HR were
not significantly different in the sedation and nonsedation groups (Table 2). A clinically relevant oxygen
desaturation , 90% was observed in 16 of the 94
patients under study (17%), which was equally distributed in the two groups.
Discussion
FFB is mostly performed with the patient under
conscious sedation.1,3 However, little is known about
the relationship between sedation and patient satisfaction with the procedure.10,13–16 Various IV sedative drugs have been tested previously because of
their ability to improve patient tolerance, and currently benzodiazepines are more frequently preferred for sedation during FFB.2,3 The use of benzodiazepines seems justified by its powerful
anxiolytic and amnesiac effects, but the evidence
supporting their use remains controversial. In fact,
some clinical trials have shown a beneficial effect of
benzodiazepines on patient tolerance,13–15 whereas
other studies did not show any benefit.8 –10 Major
flaws in the trial design are apparent in these studies.
First, some trials were uncontrolled.8,9,14 Second, in
three studies, the total amount of the given local
anesthetic was not reported.8,10,15 Finally, in most
studies, the depth of sedation was not evaluated.8,9,13,15 In one study, diazepam was used in a
preestablished dose, but because of the varying
susceptibility of patients to IV sedative drugs, it is
conceivable that not all the patients could have
achieved the same degree of sedation.13 We administered a 300-mg total dose of lidocaine topically in
all patients because, in our experience and those of
others,1,16,17 such a dose induced good topical anesthesia and was below the toxic dose.18,19 The recommended dose of lidocaine ranges from 3 to 4 mg/kg
of body weight4,20 to 6 to 7 mg/kg.19 Studies have
suggested that doses higher then those recommended may be safe21–23 since much of the administered lidocaine may be swallowed or aspirated by
suction. There are great interindividual differences
in both the absorbed fraction and the clearance of
topical lidocaine.
Moreover, the two methods of anesthetic applications, spray in the upper airways and solution in the
lower airways, have different absorption profiles, and
therefore it seemed reasonable to chose a standard
safe dose. This is important in clinical practice in
which it is not possible to monitor serum lidocaine
concentrations. We did not observe any toxic effects
obviously due to lidocaine. The present study shows
that IV diazepam had a beneficial effect on patient
tolerance to FFB. All the patients in the sedation
group completed the FFB and their tolerance scores
were significantly higher than those of the nonsedation group. The tolerance score was much worse
when rated by patients than by the bronchoscopist.
This might highlight an underestimation of a patient’s discomfort by the bronchoscopist, as previously reported.13,24 These data indicate the importance of patients’ opinions in such studies, and shows
that physicians often do not fully appreciate patients’
responses to such procedures. In our study, male
patients tolerated bronchoscopy better than female
patients, confirming the results of a previous study.25
Furthermore, a high degree of anxiety before the
procedure resulted in lower patient tolerance. In this
respect, sedation with diazepam was the most important variable associated with improved patient tolerance to FFB. Age had no effect on improved patient
tolerance, contrary to a previous study.25
The usual hemodynamic response to FFB is an
increase in HR and BP together with oxygen desaturation episodes.26 –28 These changes may lead to an
increased risk of arrhythmia29 and myocardial ischemia during FFB.30 The hypoxemia has been attributed to the FFB itself 27,31 or to the respiratory
depression associated with the use of sedatives.4,32
The incidence and severity of respiratory depression
during FFB is likely to be correlated to the sedative
agent dose,25 and it is lower by using benzodiazepines than opioids.32–34
In our study, the Spo2 decreased and HR increased during FFB, but the difference between the
two groups was not statistically significant. Neither
Table 2—HR and SpO2 During Bronchoscopy
HR, beats/min
Endoscopy
Before
During
After
Spo2, %
Sedation
Nonsedation
Sedation
Nonsedation
79.6 6 14.9
104.6 6 20.8
88.9 6 17.2
80.2 6 14.8
110.2 6 21.3
86.9 6 15.1
96.1 6 1.9
90.5 6 4.8
94.1 6 2.6
96.8 6 1.6
92.5 6 5.2
94.9 6 3.2
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ST changes in the ECG, indicating myocardial ischemia, nor cardiac arrhythmias were noted during
FFB. This is in conflict with a previous study,30 even
if in our study no complex procedures were performed and all the examinations were brief. In
conclusion, the present study showed an overall
improved patient tolerance during routine FFB with
conscious sedation, and without any increased cardiorespiratory risks. The results of our study are
clinically relevant and may be helpful in reducing a
patient’s discomfort during routine FFB.
ACKNOWLEDGMENT: The authors are indebted to A.J.
Block, MD, for his kind suggestions and for reviewing the
manuscript.
17
18
19
20
21
22
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Bronchoscopy