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Opioid-free Anesthesia in VATS Lung Resection

P

Peking University

Status

Unknown

Conditions

Opioid Free Anesthesia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04507165
2020PHB031

Details and patient eligibility

About

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).

Full 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].

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

opioid-free general anesthesia
Experimental group
Description:
under opioid-free general anesthesia
Treatment:
Drug: opioid free anesthesia
Procedure: Paravertebral block+Anterior serratus plane block
opioid based general anesthesia
Active Comparator group
Description:
under opioid based general anesthesia
Treatment:
Drug: opioid based anesthesia
Procedure: Paravertebral block+Anterior serratus plane block

Trial contacts and locations

1

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Central trial contact

Feng Yi, MD,PhD

Data sourced from clinicaltrials.gov

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