BACKGROUND 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 O[.]
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: Ass Prof PhD Phan Dinh Ky 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: National library Library of 108 Institute of clinical medical pharmacological science 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 We're doing this study is titled "Study of effective spinal anesthesia with 0.5 % bupivacaine mixture of high density sufentanil - low-dose morphine for caesarean section", in order to achieve two objectives: Comparison of effects of spinal anesthesia in surgery and pain after cesarean delivery of 0.5 % bupivacaine 7.5 mg high proportion - 100mcg combined with morphine or fentanyl 20mcg sufentanil 2mcg Rating undesirable effects on mothers and fetuses when spinal anesthesia using the aforementioned drugs NEW CONTRIBUTION OF THE THESIS - The theme suitable for specialized obstetric anesthesia - This topic has significant scientific and practical, applicable in many maternity hospitals - Coordinate with sufentanil bupivacaine in spinal anesthesia for cesarean section is applied in Vietnam, combined with lowdose morphine 100mcg helps reduce postoperative pain lasted another 24 hours, very beneficial for women after surgery tongue - Comparison of the two study groups for better pain outcomes in the study group Analgesic effect fast and strong, few side effects - No effect on the fetus The structure of the thesis: 131 page thesis, apart from the question, conclusions and recommendations thesis consists of four chapters: chapter overview page 39, chapter subjects and research methods page 20, chapter study results 35 chapter discusses the page and page 31 Thesis has 40 tables, 14 charts, photos and 139 references (document 44 Vietnamese, 77 English documents and 18 documents in French) Chapter OVERVIEW 1.1 Some characteristics of anatomy, physiology of pregnant women related to anesthesia Pregnancy as the mother's body changes important to adapt to new physiological conditions to 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 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: 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 SUBJECTS AND METHODS 2.1 Study subjects: The women indicated cesarean section alone 2.2 Selection criteria for the study subjects: - The women indicated cesarean standard ASA and ASA 2, standards classification criteria of the American Association of anesthesia - The women agreed to participate in this study - There are no contraindications to spinal anesthetic 2.3 Exclusion criteria: - Pregnant women have spinal deformities - Women who neuropathy - Women who RLDM , anticoagulant treatment - Women who together with cardiovascular disease - Pregnant women are shocked - The ill woman bleeding risk: young football vegetables, vegetables striker suspected uterine rupture - Pregnant women who are allergic to anesthetics - Pregnant women who have the infection back, full body - Pregnant women who not agree with this approach 2.4 Criteria included women from the study: - Pregnant women lose blood during surgery more > 1000ml - Spinal anesthesia failure, transfer of anesthesia - In surgical complications occur in surgery or anesthesia 2.5 Sample size and study group: 2.5.1 Sample sizes: This is a clinical intervention studies randomized comparisons, so based on the formula in the documents of the World Health Organization (1991), Sample size and sampling in medical research, WHO, Geneva to calculate sample size as follows [91]: n1 n2 [ Z (1 / ) p(1 p ) Z1 [ p1 (1 p1 ) p2 (1 p2 ) ]2 ( p1 p2 ) 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 hours when using bupivacaine with fentanyl : an estimated 30 % p2: % of patients after hours postoperative pain when used in combination with sufentanil bupivacaine and morphine: an estimated 10 % P = (p1 + p2) / Z1-/2: Coefficient of confidence at 95 % probability (= 1.96); Z1-: Forces samples (= 80 %) calculated according to the formula : n1 = n2 = 56 - Thus the object of our study at least 56 women per group In this research, we take the round number of 60 women per group - Selection criteria for homogeneity 2.5.2 Divide the team: Choose random draw method, visit the group consisting of equal groups of 60 patients each Every woman would correspond to a start time to visit, catch the visiting public and classified comply with that method - Group I: Coordinate bupivacaine (marcain) 05 % high density of 7.5 mg morphine with fentanyl 20 mcg and 100 mcg - Group II: Coordinate bupivacaine (marcain) 05% high density of 7.5 mg morphine with sufentanil mcg and 100 mcg 2.6 Research Methodology 2.6.1 Study design: The study randomized clinical trials have compared 2.6.2 The means of monitoring and evaluation: 2.6.3 Methodology 2.6.3.1 Preparing patients before surgery - Check the records, medical records: name, address, and specify the operation - Exploit your medical history, especially history of allergy to antibiotics, anesthetics and other types - Measure the height , the weight of the patient - Count the pulse, BP, respiratory frequency count - Check -clinical tests - Patients with preoperative examination to exclude patients with contraindications to spinal anesthesia , especially medical conditions enclosed as heart, lung, liver and kidney that affects spinal anesthesia - Instructions for patients using VAS measurement of pain (0-10) to evaluate the patient - Explain to patients understand anesthesia methods and disturbing distress can occur when this 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 ml/250: Get ml sufentanil (250 mcg solution / ml) + ml 0.9 % NaCl solution into 10 ml (1 solution), then the solution concentration mcg / ml - Get a syringe (1 ml) 1ml smoking drug from solution 1, in this study only 2mcg sufentanil , should only take medications by 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 ml morphine (0.01 g solution / ml) + ml NaCl ‰ = 10 ml (1 solution) Get ml of + ml NaCl ‰ = 10 ml and obtained the morphine solution 100mcg/ml, this solution is mixed with bupivacaine for spinal anesthesia in this study 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 to points + Pretty: VAS score from to points + Average: VAS score of to 7diem + Poor: VAS score from 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 2.10 Ethics in research Chapter FINDINGS 3.1 Characteristics of the study subjects 3.2 Gestation by caesarean section and specify the object of study 3.2.1 Gestational age of the study subjects Table 3.3 Gestational age (weeks) Gestational age (weeks) X ± SD Min - Max Groupe I (n = 60) 39,25 ± 1,22 38 – 42 GroupeII (n = 60) 38,83 ± 1,14 38 – 41 p 0,05 Comment: Results of the study onset inhibit pain sensation at T10 of groups: group I was 2.23 ± 0.62 minutes, and group II was 1.58 ± 0.56 minutes, comparable in time groups but no difference was statistically significant with p > 0.05 3.4.2.Thoi onset inhibit pain sensation at T6 (minutes) 11 Level M0 Min – max Groupe I (n = 60) 2,60 ± 0,67 2÷4 Groupe II (n = 60) 2,83 ± 0,95 2÷5 p > 0,05 Comment: Results onset motor inhibition of group I at M is 2.60 ± 0.67 minutes, and group was 2.83 ± 0.95 minutes, compared the results of this but no difference statistically significant, with p > 0.05 3.5.2 Time onset of the active inhibitor MI (minutes) Table 3.12.Thoi onset motor inhibition in MI Level MI Min – max Groupe I (n = 60) 4,30 ± 0,88 3÷6 Groupe II (n = 60) 4,53 ± 0,94 3÷7 p > 0,05 Comment: Results inhibit onset MI campaign at roughly the same between the 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 M II Min–max Groupe I (n = 60) 6,07 ± 0,98 4÷8 Groupe II (n = 60) 6,37 ± 0,89 5÷8 p > 0,05 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 3.5.4 Time onset of motor inhibition in the M III ( minutes ) 12 Table 3.14.Thoi onset inhibition of the active M III Level of Group I Level M III Min–max Groupe I (n = 60) 7,67 ± 0,71 7÷9 Groupe II (n = 60) 7,97 ± 0,72 ÷ 10 p > 0,05 Comment: Time onset of the active inhibition of group I, III M: 7.67 ± 0.71 min, and a maximum of minutes of the second group was 7.97 ± 0.72 minutes, maximum 10 minutes This difference is not statistically significant, with p > 0.05 3.5.5 Onset time average motor inhibition (min) 3.5.6 Recovery time campaigning entirely at M III (minutes) 3.5.7 Recovery time campaigning entirely at M II (minutes) 3.5.8 Recovery time campaigning entirely at MI (minutes) 3.5.9 Recovery time campaigning totally at M0 (minutes) Table 3:19 Recovery time campaigning totally at M0 Parameters M0 Min – Max Groupe I (n = 60) 165,56 ± 18,09 140 ÷ 185 Groupe II (n = 60) 156,11 ± 19,21 135 ÷ 185 p > 0,05 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 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 13 X ± SD Min – max 23,23 ± 0,75 24,80 ± 1,09 21 – 26 23 – 28 0,05 Comment: The rate of maternal hypotension is 11.67 % of group I, group II was 8.33 % Comparison between the groups did not 14 differ much, however this result was not statistically significant , with p > 0.05 3.9 The undesirable effects 3.9.1 The level of sedation In this study, the two groups of women fully awake 3.9.2 Vomiting Side effects - nausea Table 3:31 Side effects are nausea, vomiting Vomiting, nausea Yes Not Total n 58 60 Groupe I Tỷ lệ % 3,3 96,7 100 Groupe II n Tỷ lệ % 11,7 53 88,3 60 100 p >0,05 Comment: The rate of nausea and vomiting than group I Group II high But compare its middle groups, the difference was not statistically significant, with p > 0.05 3.9.3 Side effects urinary retention Table 3:32 Urinary side effects Groupe I Tỷ lệ % Groupe II Tỷ lệ % Urinary retention n Yes 0,0 3,3 Not 60 100 58 96,7 Total 60 100 60 100 n p >0,05 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 15 Itching, original, rash Yes Not Total n Groupe I Tỷ lệ % 57 60 95 100 n Groupe II Tỷ lệ % 52 60 13,3 86,7 100 p >0,05 Comment Itching in group II ratio is 13.3% higher than in group I, in group I the result is 5% This difference was not statistically significant, with p > 0.05 3.10 The effects on the infant spinal anesthesia with drugs in research 3.10.1 Assessed by Apgar score Table 3:34 Average Apgar score First Minute Groupe I X ± SD 8,23 ± 0,04 Groupe II X ± SD 8,35 ± 0,05