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F. Andre Nindra S.

Advisor : dr. Paramita Putri Hapsari, Sp.An.Mkes.

Luiz Eduardo Imbelloni et.al.


Hospital Rio Lazajeiras, Rio de Janerio
February 2010
Laroscopic cholecyctectomy
is the choice for the
management of
symptomatic cholelithiasis

This procedure requires


general anesthesia with
tracheal intubation
Low thoracic
epidural

Regional
Spinal anesthesia
Anesthesia

Combined spinal-
epidural
Objective
To compare the possibility of
performing laparoscopic
cholecyctectomy under spinal
anesthesia versus general
anesthesia
STUDY DESIGN

• Randomized, double blind controlled trial

SUBJECTS

• 67 patients between 20 and 65 years old with ASA class I and II, BMI ≤ 32
and normal coagulation profile

PLACE

• Hospital Rio Laranjeiras, Rio de Janerio, Brasil

TIME

• July 2007 to September 2008


Inclusion Exclusion
Criteria Criteria
Patients between 20 and Cholecystitis, cholangitis
65 years old and pancreatitis

ASA class I and II


Prior laparotomy for
upper abdominal surgery
BMI ≤ 32

Normal coagulation Contraindication of spinal


profile anesthesia
67 patients assessed
for eligibility and take
informed consent

Exclusion
criteria

Randomized n = 67

Allocated to general Allocated to spinal


anesthesia (Group anethesia (Group B /
A) n = 33 control group) n = 34
Pre RL 500 ml
medication
Cephalosporin 2 g
Ranitidine 50 mg
Omeprazole 40 mg
Dexamethasone 10 mg
Ondansetron 8 mg
Metoclopramide 10 mg
• Induction  Propofol 2.5 mg/kg IV
• Fentanyl 5 mcg/kg IV
• Rocuronium 0.6 mg/kg IV and lidocain 1.5 mg/kg IV
GROUP A • Intubation
(General
Anesthesia) • TV 8 ml/kg, PEEP 5 mmH2O, sevoflurane

• Midazolam 1 mg IV
• Fentanyl 1mcg/kg IV
• Spinal anesthesia, punctured L3-L4
GROUP B • 20 mcg fentanyl and 3 mL of hyperbaric bupivacaine
(Spinal
Anesthesia) • 10-degree head down position
Post
operative
D5W 1.5 L over 24 hours

Ketoprofen 100 mg / 8 hours IV

Dipyrone 1 g / 6 hours IV
Hemodynamic
Intraoperative changes, the need of
incidents were NGT, time of
recorded anesthesia, the need of
increase IAP ≥ 8mmHg

Post operative events


were also recorded
Compare means
• Student t-test

Compare medians
• Mood test

Compare percentages
• Pearson’s chi square test

Time to blockade
• Paired t-test
Laparoscopy

Cardiac
Respiratory
Pneumo
peritoneum
Respiratory Complications
Cardiovascular complications
General Spinal
Anesthesia Anesthesia
Spinal anesthesia can be
an effective technique
for elective laparoscopic
cholecystectomy with
low pressure CO2, an it
can be an alternative for
general anesthesia
• 67 patients between 20 and 65 years old with ASA class I and II, BMI
P ≤ 32 and normal coagulation profile

• Laparoscopic cholecystectomy with Spinal Anesthesia


I
• Laparoscopic cholecystectomy with General Anesthesia
C
• To provide evidence that spinal anesthesia is better than general
O anesthesia
Design
• Double blind randomized controlled trial

Sample
• 67 patients between 20 and 65 years old with ASA class I and II, BMI ≤ 32 and
normal coagulation profile
Time
• July 2007 to September 2008

Place
• Hospital Rio Laranjeiras, Rio de Janeiro, Brasil
Is my patient so different to those in NO
the study that the results cannot
apply?
Is the treatment feasible in my YES
setting?
Will the potential benefits of YES
treatment outweigh the potential
harms of treatment for my patient?
VALID AND
APPLICABLE