Original Article Preoperative Intravenous Administration Of
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Int J Clin Exp Med 2016;9(9):18451-18457 www.ijcem.com /ISSN:1940-5901/IJCEM0016462 Original Article Preoperative intravenous administration of dezocine for cesarean section under epidural anesthesia: effects on maternal well-being and neonatal outcome Keqiang He, Jianhui Pan, Liguo Hu, Ruiting Wang, Ling Hu Department of Anesthesia, Affiliated Provincial Hospital of Anhui Medical University, Hefei 230001, China Received September 19, 2015; Accepted January 21, 2016; Epub September 15, 2016; Published September 30, 2016 Abstract: We evaluated the efficacy and safety of preoperative intravenous administration of dezocine for comfort- able birth by cesarean section under epidural anesthesia. Sixty primigravida women with full-term singletons un- derwent elective cesarean section, and were randomly divided into three groups. Patients in groups A and B were intravenously injected with 5 and 10 mg of dezocine, 10 min before skin incision, whereas patients in group C were intravenously injected with saline. We recorded data on visceral traction responses and intraoperative adverse reactions, such as nausea and vomiting. While the neonate was being delivered, the umbilical arterial and venous blood gas values were determined. The Apgar scores at 1, 5, and 10 min after delivery, as well as the Neurologic Adaptive and Capacity Score (NACS) at 15 min, 2 h, and 24 h, were recorded. The “fineness rate” required to relieve the traction reaction in group B was higher than that in group C (P < 0.05). The intraoperative Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scores of groups A and B were lower than that of group C, and the time period that the intraoperative MOAA/S score was ≤ 4 points was longer in group B (P < 0.05). The umbilical blood gas values, as well as the NACS and Apgar scores, were not statistically significantly different among the groups at any time points. The preoperative administration of 10 mg of dezocine further improved the comfort level of women during cesarean section under epidural anesthesia. Adverse maternal and neonatal effects, such as respiratory depression, were not observed. Keywords: Dezocine, cesarean section, anesthesia, epidural, Apgar score Introduction agonist/antagonist developed in the 1970s by the American Home Products Corporation [8]. Traumatic birthing experiences have significant Dezocine was approved by the Food and Drug effects on the physical and emotional well- Administration for perioperative care manage- being of women, their offspring, and their fami- ment, but was discontinued with the closure of lies [1, 2]. During a cesarean section under epi- its parent company. PubMed lists 74 articles dural anesthesia, the traction on the abdomi- related to dezocine, the first of which was pub- nal peritoneum and the delivery of the fetus are lished in Anesthesia & Analgesia in 1978, dem- accompanied by pain and discomfort, and no onstrating its use for postoperative pain man- effective intervention exists. The administra- agement [8]. Although no longer clinically used tion of opioids is avoided during cesarean sec- in Western countries, dezocine has gained pop- tion to reduce the risk of neonatal respiratory ularity in China as an alternative medicine for depression after delivery. The search for com- perioperative pain management [9, 10]. fortable medical treatments, including labor Dezocine exhibits less respiratory depression analgesia, has gained considerable attention. than pure μ-receptor agonists because the for- New μ-receptor agonists, such as remifentanil mer mainly excites the κ receptor, which results and sufentanil, have been safely applied for in spinal analgesia and sedation effects [11]; labor analgesia and anesthesia [3-7]. thus, the safety range of dezocine is wide. Dezocine is an opioid that is structurally similar Analgesia during pregnancy and childbirth is to pentazocine, a mixed opioid receptor partial mediated through the spinal endogenous opi- The efficacy and safety of dezocine oid peptides, especially in the activation of the patients in groups A and B were intravenously analgesic systems of spinal κ and δ receptors administered 5 or 10 mg of dezocine (diluted to [12-14]. We intravenously administered dezo- 5 mL with saline, batch number: 13080221, cine 10 min prior to cesarean section to ana- Yangtze River Pharmaceutical Group Co., Ltd., lyze its safety, anesthetic efficacy, and neona- China), respectively. The patients in group C tal outcome. were intravenously administered 5 mL of saline. The surgeon performed a longitudinal skin inci- Materials and methods sion along the midline 10 min later. General information Observation indexes We enrolled 60 primigravida women with full- The women’s visceral traction reactions were term singletons who underwent elective cesar- scored during the cesarean section. Grade 0 ean section (American Society of Anesthetists implies that the patient was quiet and did not [ASA] Physical Status grade I or II; age, 21-37 experience pain or discomfort; grade 1 depicts years; weight, 59-88 kg). The patients were mild discomfort without traction pain; grade 2 randomly divided into three groups, with 20 indicates mild traction pain; grade 3 implies cases per group. The participants did not exhib- significant traction pain accompanied with nau- it fetal distress, heart and lung diseases, diabe- sea, vomiting, or flatulence. Grades 0 and 1 tes, hypertension, or a history of opioid allergy. were classified as “fine”. Grades 2 and 3 were The preoperative laboratory tests showed no classified as “moderate” and “poor”, respec- abnormalities, and the acupuncture method tively. The “fineness rate” is defined as the per- revealed that the epidural block height was centage of women classified as “fine” divided over T6. Women who had epidural block heights by the total number in each group. The degrees of less than T8 or felt significant pain during the of intraoperative sedation were scored with the surgical incision were excluded. This study was Modified Observer’s Assessment of Alertness/ conducted in accordance with the declaration Sedation (MOAA/S) scale every 5 min. A of Helsinki. This study was conducted with MOAA/S score of 0 indicates the complete approval from the Ethics Committee of Affiliated absence of a response to painful stimuli; a Provincial Hospital of Anhui Medical University. score of 1 signifies the absence of a response Written informed consent was obtained from all to mild prodding or shaking but a response to participants. painful stimuli; a 2 is a response to mild prod- Anesthesia ding or shaking; 3 indicates response only after the patient’s name was called loudly and/or After the women arrived in the operating room, repeatedly; a 4 implies lethargic response to blood pressure (BP), heart rate (HR), heart the name spoken in a normal tone; and a 5 indi- rhythm (by electrocardiogram [ECG]) and arte- cates a prompt response to the name spoken. The time that the intraoperative MOAA/S score rial oxygen saturation (SpO2) were monitored. A peripheral vein was accessed to infuse 6% was ≤ 4 points was recorded. Episodes of SpO2 hydroxyethyl starch 130/0.4. Oxygen was sup- < 95%, respiratory depression, nausea, and plied via a mask at a flow rate of 2 L/min. The vomiting were recorded. After the delivery and epidural puncture was performed between the before the neonate took the first breath, two L2 and L3 spaces, and the epidural catheter forceps were used to clamp a segment of the was inserted towards the head. Approximately umbilical cord. Approximately 1 mL of blood 4 mL of 2% lidocaine was injected as the test was extracted with a heparin-coated syringe dose; 5 min later, 8-15 mL of 1% lidocaine and from both the umbilical artery and vein for 0.375% ropivacaine mixture was fractionally blood gas analysis using an i-STAT 200 (Abbott, injected so that the epidural block height US) portable blood gas analysis meter. The pH, reached T8. If the woman’s systolic blood pres- partial arterial oxygen pressure (PaO2), partial sure was < 90 mmHg or < 30% of the basic arterial carbon dioxide pressure (PaCO2), and blood pressure (i.e., hypotension), 5-10 mg of base excess (BE) inside the umbilical artery ephedrine was intravenously administered; if and umbilical vein were tested. The neonates the HR was < 60 beats/min, 0.3-0.5 mg of atro- were evaluated by Apgar scores at 1, 5, and 10 pine was intravenously administered. The min after birth. The Neurologic and Adaptive 18452 Int J Clin Exp Med 2016;9(9):18451-18457 The efficacy and safety of dezocine Table 1. Comparison of general information among the three groups and the time that the MOAA/S _ ( x ± s) score was ≤ 4 points in group Body Body weight Operation Delivery B was longer than those in Group Cases Age (years) weight (kg) gain (kg) time (min) time (s) groups A and C (P < 0.05). No A 20 28.1 ± 4.0 74.0 ± 5.8 16.1 ± 4.8 52 ± 9 399 ± 62 case in any group exhibited an intraoperative MOAA/S B 20 28.0 ± 3.2 70.9 ± 8.7 14.3 ± 6.1 56 ± 11 403 ± 60 score of < 3 points (Table 2). C 20 27.1 ± 4.1 70.1 ± 7.7 15.2 ± 5.8 53 ± 9 384 ± 54 Note: intergroup comparison, P > 0.05. Comparison of neonatal out- comes Table 2. Comparison of visceral traction reaction and MOAA/S There were no significant dif- Score among the three groups ferences (P > 0.05) among Visceral traction reaction MOAA/S Score the three groups for blood gas Group Cases Fineness Time of ≤ 4 indicators from the fetal 0 1 2 3 Mean rate (%) points (min) umbilical arteries and veins a a A 20 8 4 5 3 60 4.21 ± 0.55 22 ± 5 (pH, PaO2, PaCO2 and BE). B 20 12a 5 3 0a 85a 3.54 ± 0.55a,b 36 ± 8a,b The Apgar scores at 1, 5, and C 20 5 4 6 5 45 4.80 ± 0.40 10 ± 4 10 min after birth, likewise, Note: versus the group C, aP < 0.05; compared with the group A, bP < 0.05.