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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Postoperative Nausea and Vomiting Opioid Use Thoracic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Opioid-Free Anesthesia (OFA froup)

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

Group Type EXPERIMENTAL

Opioid-Free Anesthesia (OFA)

Intervention Type 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.

Standard general anesthesia (OA)

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

Group Type ACTIVE_COMPARATOR

Standard general anesthesia (OA)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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Non-Opioid anesthesia (NOA) Opioid-based general anesthesia

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No