Opioid-free Anesthesia in VATS Lung Resection

NCT04507165 | Unknown

• 1 other identifier: 2020PHB031
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Opioid Free Anesthesia

Keywords

Opioid Free Anesthesia; Video-assisted Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of intraoperative cardiovascular complications

  During the operation

• Incidence of postoperative cardiovascular complications

  Up to 30 days postoperation

• Duration of tracheal intubation removing

  Up to 2 hours postoperation

• Duration of departing from PACU

  Up to 4 hours postoperation

• Pain severity

  2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation

Study Arms (2)

opioid-free general anesthesia

EXPERIMENTAL

under opioid-free general anesthesia

Procedure: Paravertebral block+Anterior serratus plane block; Drug: opioid free anesthesia

opioid based general anesthesia

ACTIVE COMPARATOR

under opioid based general anesthesia

Procedure: Paravertebral block+Anterior serratus plane block; Drug: opioid based anesthesia

Interventions

Paravertebral block+Anterior serratus plane block PROCEDURE

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.

Also known as: nerve block

opioid based general anesthesia; opioid-free general anesthesia

opioid free anesthesia DRUG

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).

Also known as: OFA

opioid-free general anesthesia

opioid based anesthesia DRUG

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.

Also known as: Standard anesthesia

opioid based general anesthesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing VATS lung resection.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Agreed to participate in the trial.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (4)

• 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.

  PMID: 30418234 BACKGROUND

• 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.

  PMID: 30579391 BACKGROUND

• 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.

  PMID: 29775728 BACKGROUND

• Zhang R, Wu Y, Wang X, Zhang W, Feng Y. Efficacy of opioid-free anesthesia in reducing postoperative adverse events for thoracoscopic pulmonary surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Dec 12;25(1):607. doi: 10.1186/s12871-025-03497-x.

  PMID: 41388253 DERIVED

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Feng Yi, MD,PhD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Yi, MD,PhD

CONTACT

86-010-88325581; yifeng65@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Anesthesiology Department

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 11, 2020
• Study Start: August 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)