Opioid Use, Postoperative Nausea and Vomiting, Thoracic Diseases
Conditions
Brief summary
This study aimed to verify whether an Opioid-free Anesthesia (OFA) could effectively reduce the incidence of PONV after thoracoscopic-assisted surgery compared with standard general anesthesia (OA) regimens.
Detailed description
Postoperative Nausea and Vomiting (PONV) is one of the most common complications after general anesthesia, which significantly reduces postoperative comfort and satisfaction of patients perioperatively. Meta-analysis showed that Opioid-free Anesthesia (OFA) significantly reduced the risk of postoperative PONV events in patients undergoing gynecology, breast, and abdominal surgery compared with standard general anesthesia (OA). The main hypothesis of the study is that an OFA could reduce the incidence of PONV in patients after thoracoscopic-assisted surgery than OA.
Interventions
PROCEDUREOpioid-Free Anesthesia (OFA)
Opioid-free general anesthesia protocol: After entering the operating room, patients were given dexamethasone (5mg i.v.), atropine (0.25mg i.v.), flurbiprofen (50mg i.v.), dexmedetomidine (0.5ug/kg i.v. in 15min), and ultrasound-guided T4-5 paravertebral nerve block (0.5% Ropivacaine 20ml). Induction of anesthesia with lidocaine (1.5mg/kg i.v.), propofol (2-3mg/kg, i.v.), rocuronium (6-8mg i.v.). Intraoperative anesthesia was maintained by desflurane (0.5-1MAC), continuous intravenous infusion of dexmedetomidine (0.5ug/kg/h), and lidocaine (1.5mg/kg/h). Flurbiprofen (50 mg i.v.) given at the time of skin suture.
PROCEDUREStandard general anesthesia (OA)
Standard general anesthesia protocol: After entering the operating room, patients were given dexamethasone (5mg i.v.), atropine (0.25mg i.v.), flurbiprofen (50mg i.v.). Induction of anesthesia with lidocaine (1.5mg/kg i.v.), sufentanil (0.3-0.4ug/kg), propofol (2-3mg/kg, i.v.), rocuronium (6-8mg i.v. ). Intraoperative anesthesia was maintained by desflurane (0.5-1MAC) and continuous intravenous infusion of remifentanil (0.1-0.2ug/kg/min). Flurbiprofen (50 mg i.v.) given at the time of skin suture.
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Inpatients planning elective thoracoscopic lobectomy or wedge resection under general anesthesia
Exclusion criteria
* ASA classification \> 4 * BMI\>35kg/m2 * Unable to communicate before surgery * Received radiation therapy, chemotherapy, opioids or hormonal drugs within 14 days before surgery * Anticipated intolerance to the anesthesia protocol of this study * Expect prolonged mechanical ventilation after surgery * Decline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative nausea and vomiting | 24 hours after surgery | Assessed using Myles's simplified postoperative nausea and vomiting impact scale. The scale on the scale is a composite of the following 2 parts: (1) vomited or had dry-retching (0-3 points), and (2) nausea ( 0-3 points). (High scores represent severe). The score\>0 is regarded as PONV occurred. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The score of Simplified postoperative nausea and vomiting impact scale | 24 hours after surgery | Assessed using Myles's simplified postoperative nausea and vomiting impact scale. The score on the scale is a composite of the following 2 parts: (1) vomited or had dry-retching score (0-3 points), and (2) nausea ( 0-3 points). (High scores represent severe) |
| Quality of post-operative recovery | 24 hours after surgery | Assessed by the of quality of recovery-15 (QoR-15) scale. (0-150 points, High scores represent better) |
| Postoperative pain at rest and cough | 24 hours after surgery | Assessed by the Numerical Assessment Scale (NRS) for pain. (0-10 points, High scores represent worse) |
| The six minute walking test (6MWT) | 48 hours after surgery | Assessed by the 6MWT worksheet and report. (High scores represent better) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative length of hospital stay | Up to 7 days after surgery | Length of hospital stay in days |
| Postoperative anesthesia care unit (PACU) duration | Up to 4 hours after surgery | PACU duration in minutes |
| Intraoperative complications | From entering to leaving the operating room, an average of 4 hours | Assessed according to ClassIntra complication classifications |
| Postoperative Complications | within 7 days after surgery or discharge | Assessed according to Clavien-Dindo surgical complication classifications |
| Health and well-being after surgery | 6 month after surgery | Assessed according to the Short-Form (SF-36) health survey, included 36 items groups in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health. |
Countries
China
Outcome results
None listed