Randomized clinical trial between two sedation protocols during transcatheter aortic valve replacement procedures: Ketamine and Propofol versus Remifentanil and Dexmedetomidine.

OBJECTIVES

To compare efficacy and safety of two different sedation protocols during Transcatheter Aortic Valve Replacement (TAVR); Ketamine and Propofol (KETOFOL) versus Remifentanil and Dexmedetomidine (REMIDEX).

DESIGN

Monocentric, prospective, randomized and controlled trial.

SETTING

University hospital.

PARTICIPANTS

231 patients were enrolled in the trial. 198 patients were included in the final analysis.

INTERVENTIONS: Patients enrolled underwent procedural sedation according to one of the two possible drug combinations, KETOFOL vs REMIDEX, assigned through randomization. During the procedure intervention times and clinical parameters were recorded. After the procedure incidence of postoperative adverse events were recorded.

MEASUREMENTS AND MAIN

RESULTS

REMIDEX group showed a higher trend in the raw incidence of respiratory acidosis (67.7 % vs 54.3 %). The correlation was confirmed in the multivariate logistic regression analysis, with an increased risk of developing respiratory acidosis in the REMIDEX group (OR 1.864 %, 95 % CI 1.014-3.427). Patients in the REMIDEX group showed significantly longer induction times. REMIDEX group required a greater number of pharmacological adjustments, had a higher incidence of intraoperative agitation, and more episodes of desaturation. No other differences were observed in any of the other intraoperative or postoperative safety indicators.

CONCLUSIONS

Both protocols showed a low and comparable incidence of cardiovascular adverse events and postoperative complications such as POD and POCD. KETOFOL protocol appears to offer greater sedative stability and seems to be more protective regarding the incidence of respiratory adverse events.