Skip to main content
OpenTrials
Completed

NCT Number: NCT05411159

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Nausea and Vomiting Nausea Opioid Use Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Digestive Thoracic Diseases Vomiting

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid-Free Anesthesia (OFA)

Procedure

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.

Other names: Non-Opioid anesthesia (NOA)

Standard general anesthesia (OA)

Procedure

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.

Other names: Opioid-based general anesthesia

Primary outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: 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 outcomes

  1. The score of Simplified postoperative nausea and vomiting impact scale

    Time frame: 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)

  2. Quality of post-operative recovery

    Time frame: 24 hours after surgery

    Assessed by the of quality of recovery-15 (QoR-15) scale. (0-150 points, High scores represent better)

  3. Postoperative pain at rest and cough

    Time frame: 24 hours after surgery

    Assessed by the Numerical Assessment Scale (NRS) for pain. (0-10 points, High scores represent worse)

  4. The six minute walking test (6MWT)

    Time frame: 48 hours after surgery

    Assessed by the 6MWT worksheet and report. (High scores represent better)

Other outcomes

  1. Postoperative length of hospital stay

    Time frame: Up to 7 days after surgery

    Length of hospital stay in days

  2. Postoperative anesthesia care unit (PACU) duration

    Time frame: Up to 4 hours after surgery

    PACU duration in minutes

  3. Intraoperative complications

    Time frame: From entering to leaving the operating room, an average of 4 hours

    Assessed according to ClassIntra complication classifications

  4. Postoperative Complications

    Time frame: within 7 days after surgery or discharge

    Assessed according to Clavien-Dindo surgical complication classifications

  5. Health and well-being after surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Registry information

Official study 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

Acronym: OFA-PONV

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2022
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.