MINISTRY OF EDUCATION AND TRAINNING - MINISTRY OF DEFENCE
108 INSTITUTE OF CLINICAL MEDICAL AND PHARMACEUTICAL SCIENCE
NGUYEN THE LOC
EFFECTIVENESS RESEARCH SPINAL ANESTHESIA
WITH A MIXTURE OF 0,5% BUPIVACAINE HIGH DENSITY -SUFENTANIL – LOW DOSE
MORPHINE FOR CESAREAN
Specialty: Anesthesiology
Code: 62. 72. 01. 22
SUMMARY OF DOCTORAL THESIS MEDICINE
Hanoi – 2013
THE THESIS WAS DONE IN: 108 INSTITUTE OF CLINICAL MEDICAL AND PHARMACEUTICAL
SCIENCE
Scientific instructors:
1. Ass Prof. PhD. Phan Dinh Ky
2. Ass Prof. PhD. Cong Quyet Thang
Objection 1:
Objection 2:
Objection 3:
This thesis will be presented at Institute Council at:
Day Month Year
The thesis can be found at:
1. National library
2. Library of 108 Institute of clinical medical pharmacological science
1
BACKGROUND
Anesthesia, obstetric anesthesia, especially in caesarean section are more complicated because
most cases of cesarean section was emergency surgery, preoperative preparation is not entirely as
desired, required posed for anesthesia are: Ensuring safety for mother; ensure safety for the
developing fetus and child after birth; maximum advantage for the surgeon conducting the
operation .
ensure good for both mother and fetus.
1.1.1 . The spine , the spinal cavity and
1.1.2 . Changes in respiratory
1.1.3 . Changes in the circulatory system
1.1.4 . Changes in the digestive system
1.2 . A brief history of spinal anesthesia for caesarean section
1.3 . Regional anesthesia for caesarean section
1.4 . Physiology of pain
1.4.1 . Definition of pain
According to the International Association for Research on Pain (IASP - International
Association for the Study of Pain) definition: pain is an unpleasant situation in terms of feelings
and emotions are caused by tissue damage existence (real or potential in the model depends on the
cause and severity of her injuries).
1.5. The drugs used in spinal anesthesia for cesarean
1.5.1. Pharmacology anesthetic bupivacaine:
5
1.5.2. Sufentanil pharmacological drugs.
1.5.2.1. Pharmacokinetics
- Sufentanil is fat soluble so similar pharmacokinetics of fentanyl .
- Do sufentanil have a higher degree of ionization at physiological pH and level of protein
binding in plasma is higher, so it has a smaller volume of distribution and half-life shorter than
fentanyl .
1.5.3 . Pharmacology Fentanyl drug
1.5.4. Morphine pharmacological drugs (type no preservatives
- Opiphin or Morphine sulphate
Chapter 2
SUBJECTS AND METHODS
2.1 . Study subjects:
The women indicated cesarean section alone.
2.2 . Selection criteria for the study subjects:
22111)2/1(
21
)(
])1()1([)1(2[
pp
ppppZppZ
nn
−
−+−+−
==
−−
βα
Among them:
n1: sample size of the control group (group I).
n2: sample size of the study group (group II ).
P1: % of patients with postoperative pain after 6 hours when using bupivacaine with fentanyl :
an estimated 30 %
p2: % of patients after 6 hours postoperative pain when used in combination with sufentanil
bupivacaine and morphine: an estimated 10 %
P = (p1 + p2) / 2
Z
1-
α
/2
: Coefficient of confidence at 95 % probability (= 1.96);
Z
1-
β
: Forces samples (= 80 %) .
calculated according to the formula : n1 = n2 = 56
procedure to the patient and cooperative.
2.6.3.2 . Spinal anesthesia technique
* How to infusion sufentanil used in the study:
After breaking inhaler mcg sufentanil 5 ml/250:
Get 1 ml sufentanil (250 mcg solution / 5 ml) + 9 ml 0.9 % NaCl solution into 10 ml (1
solution), then the solution concentration 1 5 mcg / ml.
- Get a syringe (1 ml) 1ml smoking drug from solution 1, in this study only 2mcg sufentanil , should
only take medications by 4 lines in 1mL syringe to mix with the local anesthetic bupivacaine, which is
2mcg sufentanil spinal anesthesia in this study.
* The solution to infusion of morphine 0.1 mg / ml:
Get 1 ml morphine (0.01 g solution / ml) + 9 ml NaCl 9 ‰ = 10 ml (1 solution).
Get 1 ml of 1 + 9 ml NaCl 9 ‰ = 10 ml and obtained the morphine solution 100mcg/ml, this
solution is mixed with bupivacaine for spinal anesthesia in this study.
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2.7. The goals of the monitoring and evaluation methods.
2.7.1. Evaluate the effect of inhibiting pain
2.7.2. Evaluate the effect of inhibiting movement.
2.7.3. Evaluate postoperative analgesia
Based on the VAS scale , Oates said:
+ Good: The VAS from 0 to 2 points
+ Pretty: VAS score from 2 to 5 points
+ Average: VAS score of 5 to 7diem
+ Poor: VAS score from 7 to 10 points
2.7.4. The undesirable effects:
2.8. Methods of data collection study in the newborn
2.9. Treatment results of the study:
The research data were collected according to the study check and is processed at the Center for
Clinical Epidemiology, Hanoi Medical University, using statistical software SPSS 16.0 and Epi
DATA .
- The value of p < 0.05 was considered significant difference statistically.
p
12
T10
X ± SD
2,23 ± 0,62 1,58 ± 0,56
>0,05
Min - Max 1– 4 1 – 3
Comment:
Results of the study onset inhibit pain sensation at T10 of 2 groups: group I was 2.23 ± 0.62
minutes, and group II was 1.58 ± 0.56 minutes, comparable in time 2 groups but no difference was
statistically significant with p > 0.05.
3.4.2.Thoi onset inhibit pain sensation at T6 (minutes)
Table 3.7. Time onset of pain inhibition at T6
Groupe
Parameters
Groupe I
(n = 60)
Groupe II
(n = 60)
p
T6
X ± SD
3,83 ± 1,06 2,95 ± 0,57
> 0,05
Min - Max 2 – 9 2 – 5
Comment:
Standby time pain killers at T6 between two different research groups, however this difference
was not statistically significant with p > 0.05 .
3.4.3.Thoi onset inhibit pain sensation at T4 (minutes)
Table 3.8.Thoi onset pain inhibition in the T4
women
Rate %
Good 57 95 59 98,3
>0,05Average 3 5 1 1,7
Poor 0 0 0 0
Comment:
Group II 98.3 % rate is good, only 1 patient had an average pain level of 1.7 %. While I have 3
groups of patients with an average pain level of 5%. However, all patients should use more fentanyl
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100mcg is enough pain to surgery. The two groups do not have the case transferred to the poor analgesic
anesthesia. This comparison is not statistically significant, with p > 0.05.
3.4.5. Time inhibited completely pain (minutes)
Table 3.10. Time inhibited completely pain
Groupe
Parameters
Groupe I
(n = 60)
Groupe II
(n = 60)
p
T10
X ± SD
175,03 ± 23,9 198,01 ± 20,07
<0,05
Min – Max 150 – 210 170 – 230
T6
X ± SD
121,15 ± 12,44 152,12 ± 15,12
<0,05
Min – Max 100 – 150 130 – 170
Level
Groupe I
(n = 60)
Groupe II
(n = 60)
p
M I 4,30 ± 0,88 4,53 ± 0,94
> 0,05
Min – max 3 ÷ 6 3 ÷ 7
Comment:
16
Results inhibit onset MI campaign at roughly the same between the 2 study groups, the first
group was 4.30 ± 0.88 minutes, and group II was 4.53 ± 0.94 minutes. Compare this result is not
statistically significant, with p > 0.05.
3.5.3 . Time onset of motor inhibition in the M II
Table 3.13.Thoi onset motor inhibition in M II
Level of Group I
Level
Groupe I
(n = 60)
Groupe II
(n = 60)
p
M II 6,07 ± 0,98 6,37 ± 0,89
> 0,05
Min–max 4 ÷ 8 5 ÷ 8
Comment:
Time onset of the active inhibition of group II M I is 6.07 ± 0.98 minutes, and group II was 6.37
± 0.89 minutes, a long time in group II than group I. However, this difference was not statistically
significant with p > 0.05 .
Min – Max 140 ÷ 185 135 ÷ 185
Comment:
Recovery time campaigning totally at M0 group I was 165.56 ± 18.09 minutes and the second group
was 156.11 ± 19.21 minutes, so the group II athletes recover faster than group I. However, this difference
was not statistically significant, with p > 0.05.
3.6. Postoperative analgesia
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3.6.1. Postoperative analgesia time (hours)
Table 3:21. Time for postoperative pain relief
Times
(h)
Groupe I
(n = 60)
Groupe II
(n = 60)
p
X
± SD
23,23 ± 0,75 24,80 ± 1,09
<0,05
Min – max 21 – 26 23 – 28
Comment:
Two research groups have used morphine 100mcg , the results are equivalent , postoperative
analgesic time of group II was 24.80 ± 1.09 hours and the group I was 23.23 ± 0.75 hours. Compare
this time in the 2 groups are different and there are statistically significant with p < 0.05 .
3.6.2. The amount of pain medication needed after surgery
3.7. The effects on the respiratory system when spinal anesthesia with drugs in research
3.7.1. Breathing frequency over time.
3.7.2. Oxygen saturation over time
3.8.The effects on the circulatory system when spinal anesthesia with drugs in research
Not 58 96,7 53 88,3
20
Total 60 100 60 100
Comment:
The rate of nausea and vomiting than group I. Group II high But compare its middle 2 groups,
the difference was not statistically significant, with p > 0.05 .
3.9.3. Side effects urinary retention
Table 3:32. Urinary side effects
Urinary retention
Groupe I Groupe II
p
n Tỷ lệ % n Tỷ lệ %
Yes 0 0,0 2 3,3
>0,05
Not 60 100 58 96,7
Total 60 100 60 100
Comment:
Side effects urinary retention in group II was 3.3 % and the group I was not any cases urinary
retention after cesarean section . The difference in the two groups of this study was not statistically
significant, with p > 0.05 .
3.9.4 . Side effects: itching, original, rash
Table 3:33. Side effects itching, original, screen
Itching, original, Groupe I Groupe II p
21
rash
n Tỷ lệ % n Tỷ lệ %
Yes 3 5 8 13,3
>0,05
Not 57 95 52 86,7
Total 60 100 60 100