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
Overview
- Phase
- Not Applicable
- Intervention
- Paravertebral block+Anterior serratus plane block
- Conditions
- Opioid Free Anesthesia
- Sponsor
- Peking University People's Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Total incidence of opioid-related adverse effects of 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
- Last Updated
- 5 years ago
Overview
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).
Detailed 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 \[e.g. duration of tracheal extubation, departing from post-anaesthesia care unit (PACU), exhaust, defecation, and stay in hospital postoperatively\].
Investigators
Yi Feng, MD
Chief of the Anesthesiology Department
Peking University People's Hospital
Eligibility Criteria
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
Arms & Interventions
opioid-free general anesthesia
under opioid-free general anesthesia
Intervention: Paravertebral block+Anterior serratus plane block
opioid-free general anesthesia
under opioid-free general anesthesia
Intervention: opioid free anesthesia
opioid based general anesthesia
under opioid based general anesthesia
Intervention: Paravertebral block+Anterior serratus plane block
opioid based general anesthesia
under opioid based general anesthesia
Intervention: opioid based anesthesia
Outcomes
Primary Outcomes
Total incidence of opioid-related adverse effects of 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
Time Frame: 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.
Secondary Outcomes
- 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)
- Dosage of opioids(2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation)
- Flatus time(Up to 48 hours postoperation)
- Defecation time(Up to 48 hours postoperation)
- Postoperative duration of stay in hospital(30 days postoperation)