Table 1 Operating protocol designed for the study
Appointment | Procedures |
|---|---|
Patient selection and recruitment (T-1) | Patient selection: conducted during the initial visit Clinical data collected: age, sex, weight, height, body mass index Medical history and current medications ASA classification Pre-operative MDAS and VAS-A scores Complexity of the procedure: surgical/non-surgical Expected duration: short/long Vital parameters: SBP, DBP, MAP, HR, and SpO2 Signed informed consent for the study Inclusion criteria: verified before scheduling the dental procedure Pre-procedure instructions: fasting from solid food and alcohol from midnight before the procedure Notification that a follow-up phone call will occur the day after the intervention to collect clinical data Follow-up for oral surgery cases: scheduled seven days post-procedure for assessment and possible suture removal |
Day of the dental procedure (T0) | Patient confirmation: on the day of the procedure, the patient (or caregiver for those with cognitive disabilities) will confirm their medical history and compliance with fasting Pre-operative assessment: the patient will complete the pre-operative Newman test and VAS-T Vital signs monitoring: devices will be applied to record vital signs, including SBP, DBP, MAP, HR, RR, SpO2, and EtCO2 Venous access: peripheral venous access will be established by venepuncture with a 22 G needle cannula Sedation protocol: remimazolam besylate (Byfavo 20 mg) will be prepared, with induction and maintenance according to established protocols Satisfactory induction: defined by a VAS-T score of 8/10 and Ramsay sedation scores of 2/6 or 3/6 within two minutes Dental procedure commencement: the dental procedure will begin once anaesthesia is effective Vital parameters monitoring: vital parameters will be recorded after each administration Anaesthesiologist intervention: an anaesthesiologist will be called if Ramsay scores are ≥4 |
End of procedure (T1) | Post-procedure monitoring: the patient will be monitored by the sedation dentist until achieving a Ramsay sedation score of 2 Recovery consultation: if recovery is incomplete within two hours, an anaesthesiologist will be consulted, and 0.2 mg of flumazenil will be administered as an antagonist Data recording: success rate of sedation, completion time of the procedure, total amount of remimazolam administered, post-operative VAS-T score (if no cognitive disabilities), timing of the first verbal response, total procedure time, number of points omitted on the post-operative Newman test, PADSS score and timing of PADSS assessment, notes on anaesthesiologist intervention, onset time (time from the first drug injection to a Ramsay score of 2/6 or 3/6), recovery time (from the first verbal response to a PADSS score of 9), post-operative vital parameters (PAS, PAD, PAM, FC, FR, SpO2) at discharge, verbal evaluation of comfort and satisfaction (using a 10-point VAS), maintenance of Ramsay scores of 2/6 or 3/6 throughout the procedure, discharge time Discharge criteria: patients will be discharged after achieving a PADSS score of 9 or 10 and completing the post-operative Newman test compared to the pre-operative test Post-sedation instructions: patients will receive instructions on post-sedation care and a reminder about the follow-up phone interview |
Telephone interview (T2) | Follow-up contact: the day after the procedure, patients (or caregivers for those with cognitive disabilities) will be contacted at an agreed-upon time Data collection: clinical data will be collected regarding anterograde and retrograde amnesia, clinical effects of the administered benzodiazepine, subjective anxiolytic effects of the sedation, and intensity of intra-operative pain |
