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

Primary Purpose

Postoperative Nausea and Vomiting, Opioid Use, Thoracic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Opioid-Free Anesthesia (OFA)
Standard general anesthesia (OA)
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Chaoyang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Opioid-Free Anesthesia (OFA froup)

Standard general anesthesia (OA)

Arm Description

Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs.

Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
Quality of post-operative recovery
Assessed by the of quality of recovery-15 (QoR-15) scale. (0-150 points, High scores represent better)
Postoperative pain at rest and cough
Assessed by the Numerical Assessment Scale (NRS) for pain. (0-10 points, High scores represent worse)
The six minute walking test (6MWT)
Assessed by the 6MWT worksheet and report. (High scores represent better)

Full Information

First Posted
May 30, 2022
Last Updated
September 2, 2022
Sponsor
Beijing Chao Yang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05411159
Brief Title
Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chao Yang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Opioid Use, Thoracic Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opioid-Free Anesthesia (OFA froup)
Arm Type
Experimental
Arm Description
Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs.
Arm Title
Standard general anesthesia (OA)
Arm Type
Active Comparator
Arm Description
Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs.
Intervention Type
Procedure
Intervention Name(s)
Opioid-Free Anesthesia (OFA)
Other Intervention Name(s)
Non-Opioid anesthesia (NOA)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard general anesthesia (OA)
Other Intervention Name(s)
Opioid-based general anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of postoperative nausea and vomiting
Description
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.
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
The score of Simplified postoperative nausea and vomiting impact scale
Description
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)
Time Frame
24 hours after surgery
Title
Quality of post-operative recovery
Description
Assessed by the of quality of recovery-15 (QoR-15) scale. (0-150 points, High scores represent better)
Time Frame
24 hours after surgery
Title
Postoperative pain at rest and cough
Description
Assessed by the Numerical Assessment Scale (NRS) for pain. (0-10 points, High scores represent worse)
Time Frame
24 hours after surgery
Title
The six minute walking test (6MWT)
Description
Assessed by the 6MWT worksheet and report. (High scores represent better)
Time Frame
48 hours after surgery
Other Pre-specified Outcome Measures:
Title
Postoperative length of hospital stay
Description
Length of hospital stay in days
Time Frame
Up to 7 days after surgery
Title
Postoperative anesthesia care unit (PACU) duration
Description
PACU duration in minutes
Time Frame
Up to 4 hours after surgery
Title
Intraoperative complications
Description
Assessed according to ClassIntra complication classifications
Time Frame
From entering to leaving the operating room, an average of 4 hours
Title
Postoperative Complications
Description
Assessed according to Clavien-Dindo surgical complication classifications
Time Frame
within 7 days after surgery or discharge
Title
Health and well-being after surgery
Description
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.
Time Frame
6 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Xiang, M.D.
Phone
+8601058231330
Email
yanxiang9991@163.com
Facility Information:
Facility Name
Beijing Chaoyang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Yan, M.D.
Phone
+8618510523195
Email
yanxiang9991@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The extent to which data is shared will be determined based on the progress of the study and local healthcare policies
Citations:
PubMed Identifier
22290456
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.
Results Reference
result
PubMed Identifier
29397134
Citation
Kleif J, Waage J, Christensen KB, Gogenur 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 2017 Nov 22.
Results Reference
result
PubMed Identifier
32843333
Citation
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, Gie O, Goebel B, Hahnloser D, Herbst F, Orestis I, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.
Results Reference
result
PubMed Identifier
15273542
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. doi: 10.1097/01.sla.0000133083.54934.ae.
Results Reference
result

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

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