Scribd
Upload
79 views

Universitas Indonesia: U. Weber, M. Krammel, S. Linke, T. Hamp, T. Stimpfl, B. Reiter, W. Plӧchl

This study aimed to investigate the influence of intravenous lidocaine on the depth of anesthesia when used as an adjunct to propofol. 120 patients were randomly assigned to receive propofol with either placebo, 0.5 mg/kg lidocaine, or 1.5 mg/kg lidocaine. The primary outcome was the Cp50 value of propofol, which was measured after skin incision. The study found that both doses of lidocaine decreased the Cp50 value compared to placebo, indicating lidocaine increased the depth of anesthesia when used with propofol.

Uploaded by

golden
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
79 views

Universitas Indonesia: U. Weber, M. Krammel, S. Linke, T. Hamp, T. Stimpfl, B. Reiter, W. Plӧchl

This study aimed to investigate the influence of intravenous lidocaine on the depth of anesthesia when used as an adjunct to propofol. 120 patients were randomly assigned to receive propofol with either placebo, 0.5 mg/kg lidocaine, or 1.5 mg/kg lidocaine. The primary outcome was the Cp50 value of propofol, which was measured after skin incision. The study found that both doses of lidocaine decreased the Cp50 value compared to placebo, indicating lidocaine increased the depth of anesthesia when used with propofol.

Uploaded by

golden
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 8

UNIVERSITAS INDONESIA

INTRAVENOUS LIDOCAINE INCREASES THE DEPTH OF


ANAESTHESIA OF PROPOFOL FOR SKIN INCISION – A
RANDOMISED CONTROLLOED TRIAL

U. Weber, M. Krammel, S. Linke, T. Hamp, T. Stimpfl, B. Reiter,


W. Plӧchl

CRITICAL APPRAISAL

Presented by

MICHAEL MANDAGI
1006824094

Moderator

dr. Dita Aditianingsih, SpAn-K

DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE CARE


FACULTY OF MEDICINE, UNIVERSITY OF INDONESIA
JAKARTA MARCH
2015
HALAMAN PENGESAHAN

Critical appraisal ini diajukan oleh :

Nama : dr. Michael Mandagi


NPM : 100682409
Program Studi : Anestesiologi Dan Terapi Intensif
Judul Jurnal : Intravenous lidocaine increases the depth of anaesthesia of
propofol for skin incision – a randomised controlloed trial
Telah diterima sebagai bagian untuk melengkapi tugas ilmiah pada Program Studi
Anestesiologi Dan Terapi Intensif Fakultas Kedokteran Universitas Indonesia.

DISAHKAN OLEH

Pembimbing : dr. Dita Aditianingsih, SpAn-K ( )


Ditetapkan di : Jakarta
Tanggal :

ii
3

CRITICAL APPRAISAL

Intravenous lidocaine increases the depth of anaesthesia of propofol for skin


incision – a randomised controlloed trial
Weber U, Krammel M, Linke S, Hamp T, Stimpfl T, Reiter B, et al. Intravenous
lidocaine increases the depth of anaesthesia of propofol for skin incision - a
randomised controlled trial. Acta Anaesthesiol Scand. 2015;59(3):310-8.

General
1. Is the clinical question clearly defined? Yes
Patient : ASA I-II, aged 20–60 years, who were scheduled for
undergoing elective surgery with general anaesthesia in
supine position and would have a skin incision of greater
than 3 cm.
Intervention : Intravenous propofol and intravenous lidocaine 1.5 mg/kg,
intravenous propofol and intravenous lidocaine 0.5 mg/kg
Comparison : Intravenous propofol and the placebo (NaCl 0.9%)
Outcome(s) : Cp50 value of propofol during anaesthesia.
2. What is the clinical question evaluating
Investigate the influence of lidocaine with Cp50 value of propofol during
anaesthesia.
3. What was the study design?
Prospective, randomised, doubleblind, placebo-controlled clinical study.
4. Was there a clearly focused clinical question and primary hypothesis?
Yes. In addition to propofol anaesthesia, an intravenous bolus of lidocaine
1.5 mg/kg will decrease the Cp50 value of propofol during anaesthesia.
5. Are there any declare conflict of interest that bias the result of the
study? No

Methodology
Population
1. What was the sampling method?

Universitas Indonesia
4

Randomised, doubleblind, placebo-controlled clinical study, 20–60 years


old ASA I-II patient undergoing elective surgery with general anaesthesia
in supine position and would have a skin incision of greater than 3 cm.
2. Were the inclusion/ exclusion criteria clearly defined? Yes
The inclusion criteria: ASA I-II, aged 20–60 years, who were scheduled
for undergoing elective surgery with general anaesthesia in supine position
and would have a skin incision of greater than 3 cm.
The exclusion criteria: Patient with body mas index > 30 and < 18.5,
required tracheal intubation, significant cardiovascular, respiratory, hepatic
or renal disease, arrhythmias, epilepsy, history of alcohol or drug abuse,
acute or chronic pain, anxiety or mental disorders, physical ability of < 5
metabolic equivalent of task, known lidocaine allergy, and pregnancy.
3. Did the sample include a representative spectrum of subject? Yes
4. How was the sample size determined?
The author assumed that the average Cp50 value is 15 μg/ml and
considered a standard deviation of 20% (about 3 μg/ml) as significant from
a clinical point of view. The difference between the Dixon and Massey
estimators for the median Cp50 value has a standard error of
approximately sqrt(2) × 3/sqrt(N). Therefore, n = 4 is required per group to
achieve a 80% power using a two-sided z-test, with a significance level of
0.05 under the assumption of a Cp50 value of 10 μg/ml in the 1.5 mg/kg
lidocaine group. Assuming that ng is approximately 2 × N leads to a
sample size of 2 × n = 8 per group, a sample size of 12 per group is
required. The author then increased this to 18 pergroup as we observed
that gross purposeful movements were observed when propofol target
levels were below 9-6 μg/ml. Levels were lower than we first assumed
therefore, the group size was increased to 18 per group.
5. Do the authors explain how selection bias was minimized? Yes,
restriction in inclusion and exclusion criteria.
6. Was allocation of subject to intervention and control groups concealed
from the researchers?

Universitas Indonesia
5

Yes. Only the study nurse who prepared the study medication knew the
allocation of subjects.

Confounders
1. Were the intervention group and control group similar at the start of
the study?
There were no division for intervention and control group. But the
lidocaine 1,5 mg, lidocaine 0,5 mg/kg, and placebo group were similar at
the start of the study.
2. Were the group treated equally except for the receipt of intervention?
Yes.
3. How were patient allocated to the treatment and control groups?
Following written informed consent being obtained, patients were
randomly allocated into one of three groups: the first group received
intravenous propofol and the placebo (NaCl 0.9%), the second group
received intravenous propofol and intravenous lidocaine 0.5 mg/kg, and
the third group received intravenous propofol and intravenous lidocaine
1.5 mg/kg. This was performed using block randomisation with a pre-
defined randomisation sequence.
4. Were either the researchers or subjects blinded to the treatment? Yes.
5. Was the blinding process clearly explained? Yes
6. Was the adequate placebo used in the controlled group? Yes.
7. Were the clinical endpoints measured clearly stated? Yes
8. How was the clinical endpoint measured ?
Upon arriving at the operating theatre, the electrocardiogram, pulse
oximetry, non-invasive blood pressure and bispectral index (BIS)
monitoring (BIS monitor model A-2000, software version 3.3 with an
averaging window of 15 s by Aspect Medical Systems, Norwood, MA,
USA) were obtained. A peripheral venous line was inserted for induction
of general anaesthesia. During anaesthesia, an arterial line was inserted for
blood sampling. Before the induction of anaesthesia, patients received a

Universitas Indonesia
6

fluid bolus of 10 ml/kg Ringer’s lactate solution, and then throughout


anaesthesia a continuous administration of 10 ml/kg/h Ringer’s lactate
solution. In case of hypotension (mean arterial blood pressure of less than
55 mmHg), patients received intravenous neosynephrine (phenylephrine)
0.02–0.1 mg per bolus. In all three groups, intravenous propofol was used
as the sole agent for anaesthesia and was administered continuously by a
targeted controlled infusion propofol infusion pump (‘Perfusor space’, B
Braun Melsungen AG, Melsungen, Germany). The infusion pump used the
Schneider algorithm, the infusion control algorithm and the
pharmacogenetic model as developed by the University of Glasgow.
After start of anaesthesia, patients received no other anaesthetic
substances or drugs and were given 100% oxygen. Once both the BIS
value dropped below 40 and the patient spontaneously stopped breathing, a
laryngeal mask was inserted.
Due to the hysteresis effect between blood and effect site of
propofol, the propofol infusion was maintained for a minimum of 15 min
in order to reach an equilibrium before the study medication could be
injected and the Cp50 value obtained. Before the administration of
intravenous lidocaine, an investigator called out the patient’s name, tapped
gently on the patient’s shoulder and asked the patient to open his/her eyes.
When a complete loss of response was documented, the study medication
was administered. Exactly 3 min after the study medication was injected,
the surgeon started with the skin incision. The skin incision was at least 3-
cm long, but not longer than 5 cm. The surgeon only cut into the
subcutaneous tissue. He made a single incision and waited for 2 min to
watch for gross purposeful movement and all measurements to be taken.
Gross purposeful movement of the head or limbs within 1 min after
incision was defined as a positive response. Truncal movement, facial
movement, chewing or coughing was not considered a positive movement.
Simultaneously, 1 min after skin incision, arterial blood samples
for plasma lidocaine concentrations were taken. Once the blood samples
after skin incision were taken, patients underwent the rest of the operation

Universitas Indonesia
7

with routine care and anaesthesia as prescribed by the administering


anaesthetist, including administration of additional intravenous midazolam
and fentanyl. The total concentration of lidocaine in plasma was
determined by gas chromatography-mass spectrometry after liquid–liquid
extraction.

Reliability And Validity


1. Was a valid measurement of the clinical endpoint made? Yes
2. Were the endpoints assessed using validated measuring methods/
instruments? Yes
3. Is there evidence provided for the reliability of the measuring
instruments/ methods used? Yes.
4. Was training and standardization used to improve the consistency of
measurements made? Yes, there was
5. Was follow up complete and sufficient duration? Yes
6. Has an appropriate methods of statistical analysis been chosen?
Yes. Descriptive parameters of the plasma levels (number of missing values,
minimum, maximum, mean and standard deviation) were calculated for each
administered level (placebo, lidocaine 0.5 mg/kg, 1.5 mg/kg) separately.
Normally distributed data are reported as means with standard deviations and
were compared using Student’s t-test. Non-normally distributed continuous
data are reported as medians with either interquartile or total range, and were
compared using the Mann–Whitney U-test, Kruskal–Wallis test or Friedman
test as appropriate. Categorical data are reported as proportions and were
compared using the chi-squared or Fisher’s exact tests. A P-value of ≤ 0.05
was considered statistically significant.
7. How many groups were compared? Three groups

Result
1. Was the study analyzed using an intention to treat analysis? None
declared
2. How precise was the estimate of the treatment effect?

Universitas Indonesia
8

The mean Cp50 values of propofol in the three lidocaine groups and their 95%
adjusted CI can be found in Table 2. There is a significant difference between the
1.5 mg/kg lidocaine group and the other two other groups. The mean difference of
the Cp50 value between the 1.5 mg/kg and the placebo was 42%, from 8.5 μg/ml
(CI 6.0–11.625) to 4.92 μg/ml (CI 4.5–5.78). The mean difference between the 1.5
mg/kg and the 0.5 mg/kg lidocaine group was 39%. There was no significant
difference between the placebo and the 0.5 mg/kg lidocaine group. Figure 2
represents these results with the Dixon and Massey up-and-down plots.
As shown in Table 2, patients who received intravenous lidocaine 1.5 mg/kg
had higher lidocaine plasma levels than patients who received lidocaine 0.5
mg/kg. Plasma levels were 0 in the placebo group. The relationship between the
administered and the measured level for all patients can be seen in a scatter plot in
Fig. 3. Figure 4 represents the heart rate, mean blood pressure and BIS trend in the
time period from 3 min before skin incision until 2 min after skin incision in all
three groups.

Applicability
1. Are your patients similar to target population? Yes
2. Were all the relevant outcome measures considered? Yes
3. Will the intervention help your patient population? Yes
4. Are the benefits of the intervention worth the risks and costs? Yes
5. Have the patient values and preferences been considered? Yes

Universitas Indonesia

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy