Postoperative Complications Clinical Trial
Official title:
The Anesthesia Effects of Dexmedetomidine Combined With Desflurane or Propofol in Lobectomy.
In one-lung ventilation surgery, compared with dexmedetomidine combined with propofol, dexmedetomidine combined with desflurane may be beneficial to accelerate patients' recovery and reduce postoperative pulmonary complications and does not increase the incidences of delirium and postoperative nausea and vomiting.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients undergoing elective thoracoscopic unilateral lobectomy. 2. General anesthesia is required and the expected duration of one-lung ventilation is = 1h. 3. American Association of Anesthesiologists (ASA) physical condition classification I-III. 4. Patients over 18 years old. 5. Voluntary participation and ability to understand and sign the informed consent. Exclusion Criteria: 1. Obese patients (BMI>28 kg/m2). 2. patients with grade 3 hypertension (systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg). 3. Acute coronary syndrome, sinus bradycardia (heart rate < 45 beats/min), II or III degree atrioventricular block, NYHA heart function classification III or IV. 4. Patients with severe history of chronic obstructive pulmonary disease (GOLD grade III or IV of pulmonary function of chronic obstructive pulmonary disease), severe or uncontrolled bronchial asthma, pulmonary infection, bronchiectasis and thoracic deformity. 5. Pulmonary artery pressure =60 mmHg. 6. Patients with Child grade B or C of liver function. 7. Patients with chronic kidney disease in stage 4 or 5. 8. Patients with hyperthyroidism and pheochromocytoma. 9. Patients who are expected to need mechanical ventilation after operation. 10. People with hearing, intelligence, communication and cognitive impairment. 11. For any reason, it is impossible to cooperate with the study or the researcher thinks that it is not suitable to be included in this experiment. 12. patients who are expected to be transferred to ICU after operation. |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
China | The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
The Second Affiliated Hospital of Chongqing Medical University |
China,
Abe K, Shimizu T, Takashina M, Shiozaki H, Yoshiya I. The effects of propofol, isoflurane, and sevoflurane on oxygenation and shunt fraction during one-lung ventilation. Anesth Analg. 1998 Nov;87(5):1164-9. doi: 10.1097/00000539-199811000-00035. — View Citation
Bernasconi F, Piccioni F. One-lung ventilation for thoracic surgery: current perspectives. Tumori. 2017 Nov 23;103(6):495-503. doi: 10.5301/tj.5000638. Epub 2017 Jun 7. — View Citation
Campos JH, Feider A. Hypoxia During One-Lung Ventilation-A Review and Update. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2330-2338. doi: 10.1053/j.jvca.2017.12.026. Epub 2017 Dec 19. No abstract available. — View Citation
Cho YJ, Kim TK, Hong DM, Seo JH, Bahk JH, Jeon Y. Effect of desflurane-remifentanil vs. Propofol-remifentanil anesthesia on arterial oxygenation during one-lung ventilation for thoracoscopic surgery: a prospective randomized trial. BMC Anesthesiol. 2017 Jan 18;17(1):9. doi: 10.1186/s12871-017-0302-x. — View Citation
Jannu V, Dhorigol MG. Effect of Intraoperative Dexmedetomidine on Postoperative Pain and Pulmonary Function Following Video-assisted Thoracoscopic Surgery. Anesth Essays Res. 2020 Jan-Mar;14(1):68-71. doi: 10.4103/aer.AER_9_20. Epub 2020 Mar 16. — View Citation
Jiang H, Kang Y, Ge C, Zhang Z, Xie Y. One-lung ventilation patients: Clinical context of administration of different doses of dexmedetomidine. J Med Biochem. 2022 Apr 8;41(2):230-237. doi: 10.5937/jomb0-33870. — View Citation
Karzai W, Haberstroh J, Priebe HJ. Effects of desflurane and propofol on arterial oxygenation during one-lung ventilation in the pig. Acta Anaesthesiol Scand. 1998 Jul;42(6):648-52. doi: 10.1111/j.1399-6576.1998.tb05296.x. — View Citation
Kawanishi R, Kakuta N, Sakai Y, Hari Y, Sasaki H, Sekiguchi R, Tanaka K. Desflurane improves lung collapse more than propofol during one-lung ventilation and reduces operation time in lobectomy by video-assisted thoracic surgery: a randomized controlled trial. BMC Anesthesiol. 2022 Apr 29;22(1):125. doi: 10.1186/s12871-022-01669-7. — View Citation
Xia R, Xu J, Yin H, Wu H, Xia Z, Zhou D, Xia ZY, Zhang L, Li H, Xiao X. Intravenous Infusion of Dexmedetomidine Combined Isoflurane Inhalation Reduces Oxidative Stress and Potentiates Hypoxia Pulmonary Vasoconstriction during One-Lung Ventilation in Patients. Mediators Inflamm. 2015;2015:238041. doi: 10.1155/2015/238041. Epub 2015 Jul 26. — View Citation
Yuan JL, Kang K, Li B, Lu J, Miao MR, Kang X, Zhang JQ, Zhang W. The Effects of Sevoflurane vs. Propofol for Inflammatory Responses in Patients Undergoing Lung Resection: A Meta-Analysis of Randomized Controlled Trials. Front Surg. 2021 Jul 2;8:692734. doi: 10.3389/fsurg.2021.692734. eCollection 2021. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to open eyes after anesthetics withdrawal | The first time to open eyes after anesthetics withdrawal. | From time of anesthetic withdrawal to the first time of the patient open his or her eyes, assessed up to 2 hour. | |
Secondary | Incidence of delirium | The Richmond Agitation-Sedation Scale (RASS) will be used to assess the incidence of delirium. RASS is a 10-point scale, with four levels of anxiety or agitation (+1 to +4 [combative]), one level to denote a calm and alert state (0), and 5 levels of sedation (-1 to -5) culminating in unarousable (-5). The scores of +2, +3, and +4 are defined as delirium. | From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour. | |
Secondary | Incidence of nausea and vomiting | The severity of nausea and vomiting will be evaluated by visual analogue scale (VAS): a 10 cm ruler was used as a scale, one end (0 points) indicated no nausea and vomiting, and the other end was 10 cm, indicating the most severe nausea and vomiting that was unbearable (1~4 was mild, 5~6 was moderate, and 7~10 was severe). | From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour. | |
Secondary | Pain level | Numeric Rating Scale will be used to assess the degree of pain. 0~10 is used to represent different degrees of pain: 0 is no pain, 1~3 is mild pain (the pain does not affect sleep), 4~6 is moderate pain (mildly affects sleep), 7~9 is severe pain (unable to fall asleep or wakes up from sleep), and 10 is severe pain. | From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour. | |
Secondary | Incidences of other side effects | Any unquestioned side effects will be recorded, such non-planned intensive care unit transfer, unplanned reoperation, unplanned reintubation, etc. | From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour. | |
Secondary | Drugs and their dosage | These drugs and their dosage will be recorded, such as muscle relaxant antagonism, antiemetic drugs, and analgesic drugs. | From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour. | |
Secondary | QoR-40 scores | QoR-40 scores will be used to assess the quality of recovery. The questionnaire consists of five subscales: emotional status (9 items), physical comfort (12 items), psychological support (7 items), physical independence (5 items), and pain (7 items). All the items are rated on a five-point scale ranging from 1 to 5. The initial point and conversion score of each item are calculated. Depending on the question, the best answers may have a score of either 5 or 1. The best answers to positive questions are scored 5, while the best answers to negative questions are assigned the score of 1. The total score of QoR-40 is given by the summation of scores for all items and ranges from 40 to 200. The higher the score, the better is the health status.Citation | Postoperative day 1 and 3. | |
Secondary | Postoperative pulmonary complications | The incidence of postoperative pulmonary complications was assessed according to the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) definition. The severity of postoperative pulmonary complications was scored on a 0-5 scale. | First 7 postoperative days | |
Secondary | White blood cell count | White blood cell count will be used to assess the inflammatory level. | Postoperative day 1 and 3. | |
Secondary | Neutrophil ratio | Neutrophil ratio will be used to assess the inflammatory level. | Postoperative day 1 and 3. | |
Secondary | Lymphocyte ratio | Lymphocyte ratio will be used to assess the inflammatory level. | Postoperative day 1 and 3. | |
Secondary | C-reactive protein | C-reactive protein will be used to assess the inflammatory level. | Postoperative day 1 and 3. | |
Secondary | Time for tidal volume of spontaneous breathing over 300 ml | Time from anesthetics withdrawal to tidal volume of spontaneous breathing over 300 ml. | From time of anesthetic withdrawal to the patient tidal volume of spontaneous breathing over 300 ml, assessed up to 2 hour. | |
Secondary | Extubation time | Time from anesthetics withdrawal to extubation | From time of anesthetic withdrawal to the tracheal tube was extubated, assessed up to 2 hour. | |
Secondary | Postanesthesia care unit residence time | Time of staying in postanesthesia care unit | From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour. |
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