Comparison of Remifentanil Hydrochloride and Rocuronium Bromide for Video Laryngoscopy-Assisted Tracheal Intubation in Adults Undergoing General Anesthesia

The primary objective is to evaluate the benefit‑risk profile of remifentanil versus rocuronium for optimizing tracheal intubation conditions in adult patients undergoing tracheal intubation using video laryngoscopy under general anesthesia, focusing on the efficacy of achieving optimal intubation conditions and the incidence of associated adverse events.

The trial enrolled adult patients (≥18 years) of both sexes who required oro‑tracheal intubation under general anesthesia using video laryngoscopy. Participants were selected according to principal inclusion criteria that mandated an American Society of Anesthesiologists (ASA) physical status of I–III, the absence of a need for rapid‑sequence induction, and eligibility for the comparison of remifentanil versus rocuronium. The sponsor did not provide information on the total number of participants. No specific lifestyle requirements such as diet or physical activity were imposed, and exclusion was limited to conditions that would raise the ASA classification above III.

The ROCVIDEO trial is a multicentre, randomized, controlled study evaluating video laryngoscopy–assisted tracheal intubation in adult patients undergoing general anaesthesia; eligible participants are adults ≥ 18 years, ASA I‑III, requiring oro‑tracheal intubation without indication for rapid‑sequence induction. After a screening visit to confirm eligibility, subjects receive either an intravenous bolus of remifentanil (4 µg/kg) or rocuronium (0.6 mg/kg) immediately prior to induction, with allocation concealed and administered in a dose‑matched fashion. Primary outcomes include a composite safety endpoint of intubation‑ or anaesthesia‑related adverse events assessed at <20 min and up to 24 h post‑procedure, and the efficacy endpoint of failed first‑pass intubation. Participants are monitored intra‑operatively, followed up at approximately 20 min for early safety assessments, again at 24 h for late events, and complete an end‑of‑study visit thereafter; total involvement for each subject spans the operative period plus a 24‑hour postoperative observation. Early termination may occur if a serious adverse event arises, if protocol‑specified intubation cannot be performed, or if consent is withdrawn. Recruitment began on 1 September 2025 and is expected to finish on 1 December 2026.

The experimental arm utilizes remifentanil hydrochloride supplied as Remifentanil Fresenius Kabi, a solution for injection/infusion. The drug is administered intravenously as a single bolus at a dose of 4 µg/kg body weight. The bolus is given immediately prior to video‑laryngoscopy‑assisted tracheal intubation and is not repeated during the procedure. Administration time, dose, and patient weight are recorded in the electronic case report form to verify compliance.

The comparator arm employs Rocuronium Fresenius Kabi, a solution for injection/infusion containing rocuronium bromide. The muscle relaxant is given intravenously as a single bolus at 0.6 mg/kg. The injection is performed within the same pre‑intubation window as the test drug. Dose calculation, administration timing, and any deviation from the protocol are documented for monitoring participant adherence.

Both study medications are prepared by the treating anesthesiologist in a sterile environment. Drug administration follows a standardized protocol, and adherence is overseen by the study monitor through source‑document verification and review of dosing logs. No additional non‑experimental therapies are administered beyond routine peri‑operative care, which follows institutional standard‑of‑care guidelines.

The primary efficacy endpoint is the prevalence of failed first-pass intubation, defined as the inability to deliver the tracheal tube after the initial attempt to introduce the video laryngoscope into the patient’s mouth. Efficacy is assessed intra‑procedurally for each participant by the operating anesthesiologist or an independent observer at the moment of intubation. The outcome is recorded immediately after the first attempt, indicating success or failure, and subsequently aggregated for analysis. Comparative analysis of the failure rates between the remifentanil and rocuronium groups will be performed using appropriate categorical statistical methods.