The Clinical Effect of Dexmedetomidine Combined with Parecoxib Sodium
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Gu et al. BMC Anesthesiology (2020) 20:166 https://doi.org/10.1186/s12871-020-01080-0 RESEARCH ARTICLE Open Access The clinical effect of dexmedetomidine combined with parecoxib sodium on sedation, antianxiety and prevention of intubation stress in patients undergoing functional endoscopic sinus surgery: a randomised controlled trial Xiaoxia Gu1†, Xiujuan Tan2†, Jinxian Chen2, Jingjing Wang2, Yue Lu2 and Liangqing Zhang2* Abstract Background: To investigate the effect of intravenous injection of dexmedetomidine combined with parecoxib sodium on sedation and anxiety and stress response of tracheal intubation in patients undergoing functional endoscopic sinus surgery. Methods: One hundred twenty patients undergoing endoscopic sinus surgery were randomly divided into four groups: group DP, group D, group P and group N. The blood pressure (BP), heart rate (HR), blood oxygen saturation (SPO2), EEG, bispectral index (BIS), Ramsay sedation score and state anxiety questionnaire (SAI) were recorded before administration (T0), 10 min (T1), 20 min (T2) and 30 min (T3) after administration. After 30 min, endotracheal intubation was performed after anesthesia induction. The BP, HR, SPO2 were recorded 1 min before intubation (T4), intubation (T5), 3 min (T6) after intubation, 5 min (T7) after intubation, and blood samples were collected from patients before administration and after intubation 2 min to detect serum cortisol (Cor), adrenalin (E) norepinephrine (NE) and blood glucose (BS). (Continued on next page) * Correspondence: [email protected]; [email protected] †Xiaoxia Gu and Xiu Juan Tan contributed equally to this work. 2Department of Anesthesiology, the Affiliated Hospital of Guangdong Medical University, No. 57 South People’s Avenue, Xiashan District, Zhanjiang City 524001, Guangdong Province, China Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Gu et al. BMC Anesthesiology (2020) 20:166 Page 2 of 8 (Continued from previous page) Results: There was no significant difference in Ramsay sedation score before anesthesia, but the Ramsay sedation score in group D、DP was significantly higher than that in group P and group N, the BIS, BP, HR and anxiety scores were significantly lower than those in the group P and group N (p < 0.05). There was no significant difference in Ramsay sedation score, BIS value, anxiety score and BP, HR between group D and group DP (p > 0.05). Compared with T4, there was no significant difference in BIS and BP, HR in group D, group DP and group P (p > 0.05), but the BIS, BP and HR in group N were significantly higher than T4, (p < 0.05). Three minutes after intubation there was no statistical difference in the changes of Cor, E, NE and BS values compared with before intubation in group P and group DP (p > 0.05), but the changes of Cor, E, NE and BS values were significantly lower than that in group N (p < 0.05). Compared with T0, the values of NE, E, Cor, BS decreased in group D, DP and P at T4, group DP decreased more significantly than group D (p < 0.05). while the NE, E, Cor, BS of T6 are at the same level as the base value. In group N, the NE, E, Cor, BS of T4 were at the same level of T0, but significantly higher at T6.And at T6, NE and E in group D, P and N were significantly different from those in group DP (p < 0.05). Conclusion: Preoperative intravenous infusion of dexmedetomidine combined with parecoxib sodium by functional nasal endoscopy can not only calm and resist anxiety, but also better prevent stress response of endotracheal intubation, which is a safe and effective way of preoperative medication. Trial registration: ChiCTR-OPN-17010444. Prospectively registered on 16 January 2017. Keywords: Functional nasal endoscopy; dexmedetomidine; parecib sodium; sedation anxiety; intubation stress Background the trial were signed the informed consent before oper- Functional endoscopic sinus surgery (FESS) is a new ation. The trial was registered prior to patient enroll- technology rising in the field of nasal surgery, which has ment at clinicaltrials.gov (Effects of dexmedetomidine become the mainstream technology in the treatment of combined with parecoxib sodium in patients undergoing sinusitis. Because of the abundant blood vessels in the endoscopic nasal surgery rapid rehabilitation and prog- pathological part of the nasal cavity, it is easy to bleed. nosis, Principal investigator: GU Xiao-Xia, Date of regis- Therefore, in order to ensure the smooth operation of tration:16 January 2017). Trial’s clinical trial registration FESS, it is required that patients should be quiet and number is ChiCTR-OPN-17010444.The patients were have less bleeding to keep the operation field clear. At randomly divided into four groups, Dexmedetomidine + the same time, keep the respiratory tract unobstructed parecoxib sodium group (group DP), dexmedetomidine to prevent the obstruction and aspiration of the respira- group (group D), parecoxib sodium group (group P) and tory tract [1]. Since the Department of Anesthesiology normal saline group (group N)(n = 30). Randomization began to use DEX and parecoxib sodium in our hospital, was carried out by a computer-generated list of random it was found that the combination of the two drugs was numbers which were sealed in an envelope. Before worth further discussion in clinical practice. Therefore, anesthesia, an anesthesiologist who was blinded to the we used dexmedetomidine combined with parecoxib so- study opened the sealed envelope and performed the dium in patients undergoing FESS surgery. From the as- anesthesia. pects of preoperative sedation, antianxiety and Inclusion criteria: ① age 18–60, gender unlimited, intubation stress, we evaluated the clinical effect of dex- weight 45-75 kg, body mass index (BMI) 18–25 Kg / m2; medetomidine combined with parecoxib sodium in FESS ② ASA I-II; ③ tracheal intubation and intravenous gen- surgery, in order to find a suitable preoperative eral anesthesia for FESS operation, the operation time is anesthesia medication for FESS. It could provides a 1-3 h, and the tracheal tube must be removed after the direct clinical basis and reference for anesthesiologists to operation; ④ non emergency patients prepared before implement comfortable and safe anesthesia. the routine operation; ⑤ clear mind, active cooperation; ⑥ no abnormality of heart, lung, liver and kidney func- Methods tion before the operation, no hypertension, anemia, General information endocrine disease and coagulation function; ⑦ voluntary The trial adheres to CONSORT guidelines and was ap- Participated in and signed the informed consent form. proved by the Ethics Committee of the Affiliated Hos- Exclusion criteria: ① Those who are known to be pital of Guangdong Medical University. From June 2017 allergic to experimental drugs and other drugs during to December 2019, 120 patients (aged 18–60, ASA I-II) operation; ② those who have serious cardiovascular and were selected for FESS operation in otolaryngology de- respiratory diseases; ③ those whose liver and kidney partment of our hospital. All patients participating in functions are seriously damaged or whose water, Gu et al. BMC Anesthesiology (2020) 20:166 Page 3 of 8 electrolyte and acid-base balance are disordered; ④ The blood samples of patients were collected before ad- those who have serious mental diseases or have language ministration (T0), 1 min before intubation induction communication disorders, who can not understand the (T4) and 3 min after intubation (T6) to detect serum sedation score and VAS score; ⑤ those who often take cortisol (COR), adrenaline (E) and noradrenaline (NE) analgesics or sedatives; ⑥ those who have bradycardia And blood glucose (BS). Atrioventricular block; ⑦ non steroidal anti- inflammatory drug allergy; ⑧ under primary school cul- Observation indicators ture, unable to complete the questionnaire independ- Another anesthesiologist (observer) observed the sed- ently; ⑧ pregnant or lactating women; ⑨ researchers ation scores of SBP, DBP, HR, SpO2, BIS and Ramsay think it is not suitable to participate in this experiment. before administration (T0), 10 min (T1), 20 min (T2), and 30 min (T3). State Anxiety Inventory (SAI) was used Anesthesia method to assess the severity of anxiety symptoms 15 min before The patients were randomly divided into four groups: administration. The patients were asked to fill in SAI group DP, group D, group P and group N. All patients again 30 min after administration. The occurrence and were forbidden to drink for 2 h and fasted for 8 h before management of adverse reactions before operation were operation without any preoperative medication. All pa- recorded in real time, including respiratory depression, tients were sent to the anesthesia preoperative room hypooxia, hypotension and arrhythmia. Sedation and without any premedication 30 min before the surgery. anxiety assessment tool: State Anxiety Inventory (SAI) Standard monitoring consisted of five-lead electrocardi- was used to assess the severity of current anxiety symp- ography (ECG), oxygen saturation (SpO2), noninvasive toms.