Study Results
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Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-08-31
2022-07-31
Brief Summary
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Detailed Description
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The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the primary outcome measures of the total incidence of opioid-related adverse effects (including respiratory depression, hypotension, PONV and dizziness) and secondary outcome measures of incidence of intraoperative and postoperative cardiovascular complications, pain relief, analgesic requirement , and other postoperative recovery parameters \[e.g. duration of tracheal extubation, departing from post-anaesthesia care unit (PACU), exhaust, defecation, and stay in hospital postoperatively\].
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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opioid-free general anesthesia
under opioid-free general anesthesia
Paravertebral block+Anterior serratus plane block
Paravertebral block will be performed at T3 and T7 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.5% ropivacaine 10ml at each injection site. Anterior serratus plane block will be performed at the 4th rib level on the surgical side under ultrasound-guided, with 0.5% ropivacaine 15ml. The blocking range is measured by "ice cube" method 15 minutes after the procedure.
opioid free anesthesia
Anesthesia induction: Dexmedetomidine 1µg/kg (intravenous infusion within 10min), propofol 1.5-2mg/kg (intravenous bolus), lidocaine 1.5-2mg/kg (intravenous bolus), cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation), methylprednisolone 40mg (intravenous bolus), esmolol 1mg/kg (intravenous bolus), and 0.5% tetracaine 5ml for surface anesthesia of the throat.
Maintenance of anesthesia: Continuous infusion of propofol and dexmedetomidine \[0.4μg/(kg.h)\]. The infusion rate of propofol was adjusted according to bispectral index value. Cisatracurium besylate was given as needed. Flurbiprofen 50mg was given intravenously before the skin incision and suture respectively.
Remedy: If blood pressure rises (more than 30% of the mean arterial pressure after induction), and heart rate increases (more than 30% of heart rate after induction) during skin incision, lidocaine 1.5mg/kg will be given intravenously and then be continuously infused at a rate of 1.5mg/(kg.h).
opioid based general anesthesia
under opioid based general anesthesia
Paravertebral block+Anterior serratus plane block
Paravertebral block will be performed at T3 and T7 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.5% ropivacaine 10ml at each injection site. Anterior serratus plane block will be performed at the 4th rib level on the surgical side under ultrasound-guided, with 0.5% ropivacaine 15ml. The blocking range is measured by "ice cube" method 15 minutes after the procedure.
opioid based anesthesia
Anesthesia induction: Propofol 1.5-2mg/kg (intravenous bolus), sufentanil 0.3μg/kg (intravenous bolus), cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation), methylprednisolone 40mg (intravenous bolus), esmolol 1mg/kg (intravenous bolus).
Maintenance of anesthesia: Continuous infusion of propofol and remifentanil. The infusion rate of propofol was adjusted according to BIS value. The infusion rate of remifentanil was 0.1-0.5µg/(kg.min) and adjusted according to the change of heart rate and blood pressure. Cisatracurium besylate was given as needed. Sufentanil 0.1μg/kg and flurbiprofen 50mg were given intravenously before the skin incision and suture respectively.
Interventions
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Paravertebral block+Anterior serratus plane block
Paravertebral block will be performed at T3 and T7 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.5% ropivacaine 10ml at each injection site. Anterior serratus plane block will be performed at the 4th rib level on the surgical side under ultrasound-guided, with 0.5% ropivacaine 15ml. The blocking range is measured by "ice cube" method 15 minutes after the procedure.
opioid free anesthesia
Anesthesia induction: Dexmedetomidine 1µg/kg (intravenous infusion within 10min), propofol 1.5-2mg/kg (intravenous bolus), lidocaine 1.5-2mg/kg (intravenous bolus), cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation), methylprednisolone 40mg (intravenous bolus), esmolol 1mg/kg (intravenous bolus), and 0.5% tetracaine 5ml for surface anesthesia of the throat.
Maintenance of anesthesia: Continuous infusion of propofol and dexmedetomidine \[0.4μg/(kg.h)\]. The infusion rate of propofol was adjusted according to bispectral index value. Cisatracurium besylate was given as needed. Flurbiprofen 50mg was given intravenously before the skin incision and suture respectively.
Remedy: If blood pressure rises (more than 30% of the mean arterial pressure after induction), and heart rate increases (more than 30% of heart rate after induction) during skin incision, lidocaine 1.5mg/kg will be given intravenously and then be continuously infused at a rate of 1.5mg/(kg.h).
opioid based anesthesia
Anesthesia induction: Propofol 1.5-2mg/kg (intravenous bolus), sufentanil 0.3μg/kg (intravenous bolus), cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation), methylprednisolone 40mg (intravenous bolus), esmolol 1mg/kg (intravenous bolus).
Maintenance of anesthesia: Continuous infusion of propofol and remifentanil. The infusion rate of propofol was adjusted according to BIS value. The infusion rate of remifentanil was 0.1-0.5µg/(kg.min) and adjusted according to the change of heart rate and blood pressure. Cisatracurium besylate was given as needed. Sufentanil 0.1μg/kg and flurbiprofen 50mg were given intravenously before the skin incision and suture respectively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) physical status I-II.
* Agreed to participate in the trial.
Exclusion Criteria
* ASA phase III or above.
* Undergoing emergency surgery.
* Planning for thoracotomy.
* Adults protected by law (under judicial protection, guardianship or supervision), people who deprived of their liberty.
* Patients who have received general anesthesia.
* Atrioventricular block, sinus node block or intraventricular block.
* Sinus bradycardia (heart rate is less than 60 beats/min).
* Preoperative hypotension (systolic blood pressure is less than 90mmHg)
* Combined with urolithiasis, Meniere syndrome, and vertebral artery stenosis
* Combined with cerebrovascular disease.
* Contraindication to NSAIDs drug.
* Allergic to anesthetics.
18 Years
75 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Yi Feng, MD
Chief of the Anesthesiology Department
Principal Investigators
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Feng Yi, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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References
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Dinges HC, Otto S, Stay DK, Baumlein S, Waldmann S, Kranke P, Wulf HF, Eberhart LH. Side Effect Rates of Opioids in Equianalgesic Doses via Intravenous Patient-Controlled Analgesia: A Systematic Review and Network Meta-analysis. Anesth Analg. 2019 Oct;129(4):1153-1162. doi: 10.1213/ANE.0000000000003887.
Cozowicz C, Poeran J, Zubizarreta N, Liu J, Weinstein SM, Pichler L, Mazumdar M, Memtsoudis SG. Non-opioid analgesic modes of pain management are associated with reduced postoperative complications and resource utilisation: a retrospective study of obstructive sleep apnoea patients undergoing elective joint arthroplasty. Br J Anaesth. 2019 Jan;122(1):131-140. doi: 10.1016/j.bja.2018.08.027. Epub 2018 Oct 27.
Forget P. Opioid-free anaesthesia. Why and how? A contextual analysis. Anaesth Crit Care Pain Med. 2019 Apr;38(2):169-172. doi: 10.1016/j.accpm.2018.05.002. Epub 2018 Sep 13.
Other Identifiers
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2020PHB031
Identifier Type: -
Identifier Source: org_study_id
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