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Effect of dexmedetomidine versus remifentanil and sufentanil on recovery and pain after video‑assisted or robot‑assisted lung surgery in adult patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

Patients undergoing pulmonary resection surgery that is performed through video-assisted thoracoscopy or robot-assisted thoracic surgery are studied. The trial compares two ways of keeping patients comfortable during the operation: an opioid‑free anesthesia approach that uses the medication dexmedetomidine, and a conventional method that uses the opioids sufentanil and remifentanil.

The purpose of the study is to see whether the opioid‑free technique leads to a better quality of recovery on the first day after surgery. Participants will receive one of the two anesthesia plans during their operation, then they will fill out a short questionnaire about how they feel, report any pain using a simple number scale, and be observed for a few days for common post‑surgical issues such as nausea, breathing problems, and the time it takes to get moving again. Follow‑up continues for a short period after discharge to collect additional recovery information.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After joining the study, you sign the informed consent form that explains the purpose of the trial and the procedures that will be performed.

    The consent form also describes the possible risks and benefits, and confirms that participation is voluntary.

  2. Step 2

    Baseline assessments

    On the day before surgery, you perform spirometry tests using a portable electronic device to measure forced expiratory volume per second (fev1), peak expiratory flow (pef), and forced vital capacity (fvc).

    You may also complete the quality of recovery questionnaire (qor‑15) to provide a baseline score.

  3. Step 3

    Anesthesia administration during surgery

    During the operation, an intravenous (iv) medication is given according to the group to which you have been assigned.

    If you are in the test group, you receive dexmedetomidine at a dose of 1.2 µg/kg, administered continuously through the iv line for the duration of the surgery.

    If you are in a comparator group, you receive sufentanil at 1 µg/kg iv and remifentanil at 2 µg/kg iv, both given as continuous infusions throughout the procedure.

  4. Step 4

    Immediate postoperative monitoring

    After surgery, you are taken to the recovery area where vital signs are monitored.

    You complete the quality of recovery questionnaire (qor‑15) on postoperative day 0 (pod0).

    Pain is assessed using a numeric rating scale (nrs) from 0 (no pain) to 10 (worst pain) while at rest and during coughing.

    If pain is reported, intravenous morphine may be administered as needed; the total amount given is recorded up to postoperative day 2 (pod2).

    Episodes of nausea or vomiting are noted, and medication is given if required.

  5. Step 5

    Postoperative day 1 assessments

    On pod1 you complete the qor‑15 questionnaire again to evaluate recovery.

    Pain is reassessed with the nrs at rest and during coughing.

    A cognitive assessment using the confusion assessment method (cam) is performed to detect any postoperative cognitive dysfunction.

    Spirometry measurements (fev1, pef, fvc) are repeated with the same portable device used preoperatively.

    You are monitored for the return of bowel function, defined by the first passage of gas, and for any further episodes of nausea or vomiting.

    Oxygen therapy, if required, is recorded for up to 72 hours after surgery.

  6. Step 6

    Postoperative day 2 assessments

    Pain scores using the nrs are recorded again at rest and during coughing.

    Any additional morphine administered is added to the cumulative total recorded for the first two postoperative days.

    Nausea, vomiting, and bowel function are continue to be observed.

  7. Step 7

    Hospital discharge and short‑term follow‑up

    The date of first ambulation (walking) is noted, and the total length of hospital stay is recorded, with a maximum observation period of 28 days.

    Postoperative pulmonary complications are monitored according to the melbourne group scale for up to 28 days after surgery.

    Mortality is checked on postoperative day 28 (pod28).

  8. Step 8

    Six‑month follow‑up

    By telephone, you are asked to answer a simplified dn4 questionnaire to evaluate the presence of chronic pain; a score of 3 or more positive answers out of 7 indicates chronic pain.

    Pain intensity is again rated with the nrs at rest and during coughing.

    Information on any analgesic medication taken, including opioids, is collected.

Who can join the trial?

5 criteria

  • Adult patient (you must be 18 years old or older).
  • Need a lung removal operation (called pulmonary resection surgery) where either a small part of the lung (segmentectomy) or a larger part (lobectomy) will be taken, and the surgery must be done using a tiny camera through the chest (video‑assisted thoracoscopy) or with a surgical robot (robot‑assisted surgery).
  • Must be using a reliable method of birth control (effective contraception) as advised by the CFTG recommendations (CFTG gives guidelines for safe contraception).
  • Have received spoken and written information about the study and have signed a written informed consent form (a document that shows you understand the study and agree to join).
  • Be covered by a social security health insurance system (your health care is provided through the national insurance program).

Who cannot join the trial?

20 criteria

  • Emergency surgery – any operation that must be done immediately; such patients cannot join the study.
  • Epilepsy not controlled by medication – a seizure disorder that is not well‑managed with medicines.
  • Decompensated respiratory failure (severe breathing failure) when not on a ventilator.
  • Heart failure with left ventricular ejection fraction (LVEF) < 40% – the heart’s pumping ability is very weak.
  • Obstructive sleep apnea – a condition where breathing repeatedly stops during sleep.
  • Use of any of the following pain medicines at the same time: buprenorphine, nalbuphine, pentazocine, or naltrexone.
  • Having an opioid prescription before surgery (any opioid pain medication).
  • Bradycardia – a very slow heart rate (fewer than 40 beats per minute).
  • Uncontrolled low blood pressure or being in a shock state.
  • Any reason you cannot safely take non‑steroidal anti‑inflammatory drugs (NSAIDs), such as an active stomach ulcer, a history of repeated stomach bleeding, or past bleeding caused by NSAIDs.
  • Inability to complete the QoR‑15 questionnaire (the survey used to measure recovery).
  • Combined surgery – having more than one type of operation performed at the same time.
  • Being under legal protection (court‑appointed guardian), in prison, pregnant, breastfeeding, a child, or otherwise unable to give informed consent.
  • High risk that the minimally invasive procedure will need to be changed to an open chest operation (thoracotomy).
  • Severe hepatic failure – the liver is not functioning properly.
  • Acute porphyria – a rare disorder that can affect the skin and nerves.
  • Hypersensitivity (allergy) to any of the medicines used for anesthesia or their inactive ingredients.
  • Heart rhythm problems that require a permanent pacemaker that has not yet been placed (atrial‑ventricular conduction disorder).
  • Adams–Stokes syndrome – a rare condition causing sudden fainting due to heart rhythm issues.
  • Recent stroke, serious brain injury, or high pressure inside the skull (acute cerebrovascular disease, traumatic brain injury, or intracranial hypertension) when not on a ventilator.
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Investigated drugs

  • Sufentanil

    is a very strong pain‑relieving medicine that is given through a vein during surgery. In this study it is used as a comparison drug to represent the usual opioid‑based anesthesia that many patients receive, so researchers can see how recovery differs when opioids are not used.

  • Dexmedetomidine

    is a medication that calms patients and helps control pain without being an opioid. It is given through a vein and is being tested as part of the opioid‑free anesthesia plan. The goal is to see if this drug can provide good pain control and a smooth recovery without the side effects that opioids can cause.

  • Remifentanil

    is a fast‑acting opioid pain medicine given through a vein during surgery. Like sufentanil, it is used in the study as a comparison drug to show how patients recover when standard opioid anesthesia is used, allowing a direct look at the benefits of an opioid‑free approach.

What is already known about the treatment

  • SUFENTANIL

    It is given by intravenous injection during surgery to provide strong pain relief. Sufentanil is an approved, widely used drug in modern medical practice and is listed in many clinical guidelines. It is mainly used for anesthesia and for managing severe pain during and after operations. The drug works by binding to mu‑opioid receptors in the brain and spinal cord, which blocks pain signals, and it belongs to the class of synthetic opioid analgesics.

  • DEXMEDETOMIDINE

    This medication is administered intravenously as a continuous infusion to keep patients calm and comfortable during procedures. Dexmedetomidine is an approved drug that is commonly used in intensive care units and operating rooms. Its main uses are for sedation, as an add‑on to anesthesia, and to help control pain. It works by activating alpha‑2 receptors in the nervous system, which lowers the release of norepinephrine and produces a gentle, natural‑feeling sedation; it is classified as an alpha‑2 adrenergic agonist.

  • REMIFENTANIL

    Remifentanil is delivered by intravenous infusion to provide rapid, short‑lasting pain relief while a patient is under anesthesia. The drug is fully approved and is a standard part of modern anesthetic practice worldwide. It is primarily used for intra‑operative analgesia during surgery. Remifentanil binds to mu‑opioid receptors like other opioids, but it is quickly broken down by blood enzymes, giving it an extremely short duration of action; it is classified as an ultra‑short‑acting opioid analgesic.

Investigated diseases

Lung cancer - Lung cancer is a condition where abnormal cells grow uncontrollably in the lung tissue. It usually begins in the lining of the airways and can enlarge, filling space in the lungs. As the tumor expands, it may spread to nearby lung areas, lymph nodes, and eventually other organs. The growth can cause increasing cough, shortness of breath, and reduced lung function. The disease may progress slowly or rapidly depending on the specific cell type involved.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-524240-35-00Protocol code35RC23_8812_OFA-VATSEstimated enrolment176 patientsSponsorCentre Hospitalier Universitaire De Rennes

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