Clinical trial NCT04507165: Opioid-free Anesthesia in VATS Lung Resection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Free Anesthesia
Keywords: Opioid Free Anesthesia
Video-assisted Thoracoscopic Surgery
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[e.g. duration of tracheal extubation, departing from post-anaesthesia care unit (PACU), exhaust, defecation, and stay in hospital postoperatively\].

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
* Combined with cerebrovascular disease.
* Contraindication to NSAIDs drug.
* Allergic to anesthetics.

Primary outcomes:
measure: Total incidence of opioid-related adverse effects of 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
timeFrame: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours postoperation
Secondary outcomes:
measure: Incidence of intraoperative cardiovascular complications
timeFrame: During the operation
measure: Incidence of postoperative cardiovascular complications
timeFrame: Up to 30 days postoperation
measure: Duration of tracheal intubation removing
timeFrame: Up to 2 hours postoperation
measure: Duration of departing from PACU
timeFrame: Up to 4 hours postoperation
measure: Pain severity
timeFrame: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
measure: Dosage of opioids
timeFrame: 2 hours, 4 hours, 6 hours, 24 hours and 48 hours after tracheal extubation
measure: Flatus time
timeFrame: Up to 48 hours postoperation
measure: Defecation time
timeFrame: Up to 48 hours postoperation
measure: Postoperative duration of stay in hospital
timeFrame: 30 days postoperation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Feng Yi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.