Dexmedetomidine‑Based Opioid‑Free Anesthesia vs Opioid Regimen on Early Recovery after VATS or RATS Thoracic Resection

The primary objective is to compare, in patients undergoing video‑assisted or robot‑assisted thoracic segmentectomy or lobectomy, the effect of an opioid‑free anaesthesia protocol versus a standard opioid‑based intra‑operative regimen on patient‑reported quality of recovery on postoperative day 1, thereby assessing early functional outcome after pulmonary resection. Secondary objectives include: determination of the trajectory of quality of recovery within the first 24 hours post‑surgery; evaluation of pain scores at rest and during coughing; measurement of postoperative morphine consumption from day 0 to day 2; assessment of opioid‑related adverse effects (ileus, postoperative nausea‑vomiting, postoperative cognitive dysfunction) from day 0 to day 2; investigation of whether the protocol reduces postoperative pulmonary complications, improves respiratory parameters, enables earlier mobilization, shortens length of hospital stay, lowers postoperative mortality, diminishes the incidence of chronic postoperative pain at six months, and does not increase intra‑operative cardiac events.

The trial enrolled adult patients (≥18 years) of both sexes who were scheduled for pulmonary resection (segmentectomy or lobectomy) performed by video‑assisted thoracoscopy or robot‑assisted thoracic surgery. Participants were required to be affiliated with a social‑security health‑insurance system, to have received oral and written study information, and to have provided written informed consent; effective contraception was required in accordance with CFTG recommendations. Selection was based on these inclusion criteria, and no additional lifestyle restrictions (e.g., diet or physical activity) were stipulated. The sponsor did not provide the total number of participants.

The study is a prospective, multicenter, randomized, double‑blind, controlled trial comparing an opioid‑free anaesthesia protocol based on dexmedetomidine (1.2 µg/kg IV) with standard opioid‑based regimens using remifentanil (2 µg/kg IV) or sufentanil (1 µg/kg IV) in adult patients undergoing video‑assisted or robot‑assisted pulmonary segmentectomy or lobectomy. Eligible participants are screened during a pre‑operative visit (day ‑1) where informed consent is obtained, inclusion criteria are verified, and baseline measurements such as spirometry, QoR‑15 questionnaire, and vital signs are recorded. Randomization occurs after screening, and the assigned intra‑operative anesthesia is administered during the surgical procedure. Post‑operative assessments are performed on the day of surgery (POD0), on postoperative day 1 (primary endpoint assessment with the QoR‑15 questionnaire) and on POD2, evaluating pain (Numeric Rating Scale), morphine consumption, nausea/vomiting, bowel function, and cognitive status. Additional follow‑up visits include a day‑28 clinic assessment for pulmonary complications, length of stay, and mortality, and a telephone interview at six months to evaluate chronic pain and analgesic use. Participant involvement therefore extends from the screening visit through day 28, with an optional six‑month follow‑up. Early termination may occur if a participant withdraws consent, experiences a serious adverse event, fails to receive the assigned intervention, or violates major protocol criteria. Recruitment is planned to commence on 1 June 2026 and continue until 31 January 2030.

The trial compares an opioid‑free anaesthesia protocol employing intravenous dexmedetomidine with standard opioid‑based regimens that include intravenous remifentanil and sufentanil administered during video‑assisted or robot‑assisted thoracic surgery.

Dexmedetomidine is the investigational agent. It is supplied for intravenous use and is dosed at 1.2 µg/kg. The dose is calculated based on the participant’s body weight and administered as an intra‑operative infusion. The infusion is initiated after induction of anaesthesia and continued throughout the surgical procedure. Dosing adjustments are permitted only according to protocol‑defined safety parameters, and infusion rates are recorded in the case report form to monitor compliance.

Remifentanil serves as a comparator opioid. It is administered intravenously at a dose of 2 µg/kg. The drug is given as a continuous infusion initiated after induction and maintained until skin closure. The infusion rate is adjusted to achieve target haemodynamic parameters, and all changes are documented to ensure protocol adherence.

Sufentanil is the second comparator opioid. It is delivered intravenously at 1 µg/kg. The dose is administered as a bolus at induction, with optional supplemental doses intra‑operatively as required by the anaesthetist. Each administration is logged to verify compliance with the dosing schedule.

Efficacy will be evaluated primarily by the score obtained from the self‑administered QoR‑15 questionnaire on postoperative day 1 (POD1). Secondary efficacy measures include the QoR‑15 score on POD0 and POD1, pain intensity assessed with a standard Numeric Rating Scale (NRS) at rest and during coughing on POD0, POD1 and POD2, and the cumulative dose of morphine administered postoperatively up to POD2.

Additional secondary parameters comprise the number of episodes of postoperative nausea and vomiting requiring treatment up to POD2, time to first postoperative flatus (censored at POD2), and the occurrence of postoperative cognitive dysfunction on POD1 assessed with the Confusion Assessment Method (CAM) or CAM‑ICU validated in French. Postoperative pulmonary complications will be recorded within 28 days using the Melbourne Group Scale (≥4 of 8 criteria). Pulmonary function will be measured preoperatively (day ‑1) and on POD1 using a portable electronic spirometer to obtain forced expiratory volume in one second (FEV₁), peak expiratory flow (PEF) and forced vital capacity (FVC). Duration of postoperative oxygen therapy during the first 72 hours, time to first ambulation (censored at 28 days), total length of hospital stay (censored at 28 days) and mortality at POD28 are also captured.

Long‑term efficacy outcomes include the proportion of patients with chronic pain at 6 months assessed by a simplified DN2 questionnaire (positive if ≥3 of 7 answers) and the full DN4 questionnaire (positive if ≥4 of 10 answers), pain intensity by NRS at rest and during coughing at 6 months, and overall analgesic consumption, including opioids. Intraoperative cardiac safety will be monitored by recording episodes of bradycardia (heart rate < 45 bpm), hypotension (mean arterial pressure < 65 mmHg) and hypertension (mean arterial pressure > 90 mmHg). All assessments are scheduled at the specified postoperative days or pre‑operative baseline as described, and data will be analyzed according to the predefined statistical plan.