Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery

Opioid Use Clinical Trial

— OFA-PONV  

Official title:

The Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery: a Single-center Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411159
• Other study ID #: 2022020817
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2022
• Source: Beijing Chao Yang Hospital
• Contact: Yan Xiang, M.D.
• Phone: +8601058231330
• Email: yanxiang9991[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Opioid Use
• Postoperative Nausea and Vomiting
• Thoracic Diseases
• Vomiting

Intervention

Procedure:
• Opioid-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.
• Standard 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.

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gié O, Goebel B, Hahnloser D, Herbst F, Orestis I, Joller S, Kan — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation

Kleif J, Waage J, Christensen KB, Gögenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub — View Citation

Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative length of hospital stay	Length of hospital stay in days	Up to 7 days after surgery
Other	Postoperative anesthesia care unit (PACU) duration	PACU duration in minutes	Up to 4 hours after surgery
Other	Intraoperative complications	Assessed according to ClassIntra complication classifications	From entering to leaving the operating room, an average of 4 hours
Other	Postoperative Complications	Assessed according to Clavien-Dindo surgical complication classifications	within 7 days after surgery or discharge
Other	Health and well-being 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.	6 month after surgery
Primary	Incidence of postoperative nausea and vomiting	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.	24 hours after surgery
Secondary	The score of Simplified postoperative nausea and vomiting impact scale	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)	24 hours after surgery
Secondary	Quality of post-operative recovery	Assessed by the of quality of recovery-15 (QoR-15) scale. (0-150 points, High scores represent better)	24 hours after surgery
Secondary	Postoperative pain at rest and cough	Assessed by the Numerical Assessment Scale (NRS) for pain. (0-10 points, High scores represent worse)	24 hours after surgery
Secondary	The six minute walking test (6MWT)	Assessed by the 6MWT worksheet and report. (High scores represent better)	48 hours after surgery