Opioid-free Anesthesia in VATS Lung Resection

Opioid Free Anesthesia Clinical Trial

Official title:

The Effect of Opioid-free Anesthesia on Postoperative Analgesia-related Adverse Reactions in Lung Resection With Video-assisted Thoracoscopic Access: a Randomized Double-blind Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04507165
• Other study ID #: 2020PHB031
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: July 2022

Study information

• Verified date: August 2020
• Source: Peking University People's Hospital
• Contact: Feng Yi, MD,PhD
• Phone: 86-010-88325581
• Email: yifeng65[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A comparison of incidences of postoperative opioid-related adverse effects and recovery parameters in patients undergoing video-assisted thoracoscopic surgery (VATS) lung resection receiving opioid or opioid-free general anesthesia (OFA).

Description:

Video-assisted thoracoscopic surgery (VATS) lung resection is traditionally performed under general anesthesia with opioid‑based analgesia. It is associated with higher incidences of respiratory depression, hypotension, postoperative nausea and vomiting (PONV), dizziness, constipation and urinary retention, and more severe acute postoperative pain.

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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Undergoing VATS lung resection.

• American Society of Anesthesiologists (ASA) physical status I-II.

• Agreed to participate in the trial.

Exclusion Criteria:

• Pregnant women

• 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.

Related Conditions & MeSH terms

• Opioid Free Anesthesia

Intervention

Procedure:
• 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.

Drug:
• 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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

Dinges HC, Otto S, Stay DK, Bäumlein 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total incidence of opioid-related adverse effects of 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation	The total incidence refers to the sum of the incidence of opioid-related adverse effects at 2h, 4h, 6h, 24h and 48h postoperationOpioid-related adverse effects here including respiratory depression, hypotension, PONV and dizziness.	2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
Secondary	Incidence of intraoperative cardiovascular complications	Including the incidence of arrhythmia, the probability of using hyperensor and hypotensor.	During the operation
Secondary	Incidence of postoperative cardiovascular complications	Including the incidence of arrhythmia, the probability of using hypertensor and hypotensor.	Up to 30 days postoperation
Secondary	Duration of tracheal intubation removing	From anesthetic discontinuance to tracheal extubation	Up to 2 hours postoperation
Secondary	Duration of departing from PACU	From tracheal extubation to Aldrete score>9. Aldrete score is the standard for departing from PACU which includes five contents to evaluate: activity, breath, blood pressure, state of consciousness and oxygen saturation by pulse oximetry (SpO2). 2 point in total for each content. 2 point refers to the best state, whereas 0 point refers to the worst state. When a patient's total score greater than 9 who will be transferred out of PACU.	Up to 4 hours postoperation
Secondary	Pain severity	Using 0-10 numerical rating scale (NRS). The NRS score is ranged from 0 to 10. 0 means without pain. 1-3 means mild pain. 4-6 means moderate pain. 7-9 means severe pain. 10 means intense pain and can't bear.	2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
Secondary	Dosage of opioids	Total dosage of opioids postoperation	2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
Secondary	Flatus time	From the operation finished to first-time exhaust	Up to 48 hours postoperation
Secondary	Defecation time	From the operation finished to first-time defecation	Up to 48 hours postoperation
Secondary	Postoperative duration of stay in hospital	The duration when patients stay in hospital after surgery.	30 days postoperation