Emergence agitation is a very common adverse event which is seen in upto 47% of elderly patients undergoing elective surgery

It is distressing not only for the patient but also for the relatives who cater to such elderly patients

It may also lead to serious complications, such as aspiration, self-extubation, self-harm, and removal of indwelling vascular or urinary catheters

According to previous studies, orientation with verbal reminders of time, place and person caused improvement in delirium of the elderly patients in ICU setting

The novelty of this study is that repeated verbal orientation of time, place, and person with noise cancellation device has rarely been assessed inside an operating room. If it is found effective, it can very easily be applied to all patients recovering from anaesthesia.

Primary Objective of this study is to compare the  incidence of emergence agitation in senior citizens recovering from general anesthesia using the Richmond Sedation-Agitation scale between those receiving repeated verbal reminders of orientation versus those who do not receive repeated orientation.

Applying the statistical formula based on previous study of  Seohee et al ,taking level of significance of 5%, power of study = 80%, for declaring that test intervention is equal to the active control intervention, sample size of each group will be 68 with a total sample size of 136 at a two-sided p-value of 0.05

A preanesthetic check-up shall be done, patients will be screened for risk of cognitive impairment/dementia by the MINI COG test and hearing screening will be done through Rinnie’s and Weber’s tuning fork tests.

All comorbidities and laboratory values will be noted. A written informed consent shall be taken and then all eligible patients shall be included in this study. All patients shall undergo standard monitoring (electrocardiography, pulse oximetry, NIBP, end tidal carbon oxide, neuromuscular monitoring) . After preoxygenation with 100% oxygen, general anesthesia shall be induced with fentanyl 2 ug/kg slow i.v. and propofol 1.5-2 mg/kg i.v. Atracrurium 0.5 mg/kg i.v. shall be administered to facilitate intubation.  The anesthesia will be maintained with sevoflurane targeting a MAC of 0.9 to 1

At the end of the surgery, when TOF ratio reaches 0.7, reversal agent shall be administered,  the fresh gas flow will be increased from 2 to 6 L/min and the inhalational agent shall be stopped.

The verbal reminder of orientation through a pre-recorded message shall be initiated as soon as the inhalational agent is stopped.

The repeated verbal reminder, which is a pre-recorded message will be started on loop through noise- cancelling earphones, over the subject’s ears. The pre-recorded message will be played at the volume of normal conversation and repeated after a 5 sec pause.

Subjects in the orientation group shall be provided with repeated verbal reminder of orientation in hindi language: “patient’s name”, open your eyes! you’re now recovering from general anaesthesia at the AIIMS Patna hospital, your surgery is completed , open your eyes.”  Whereas those in control group will only hear their own name without any orientation from the device.

The message is to be repeated until the patients open their eyes after instructions. No tactile stimulation will be allowed during the emergence. The Richmond sedation agitation scale shall be used to evaluate emergence after eye opening in the operation theatre, score more than zero shall be considered as emergence agitation and the same to be noted if occurs.

Upon arrival in the PACU, agitation and pain scores are to be measured every 10 min during the first 30 min. The 11-point numerical rating scale (NRS) shall be used for pain evaluation.

Study also aims to evaluate incidence of delirium in senior citizen patients. Post operative delirium shall be assessed with 3 min-diagnostic confusion assessment method (3D CAM ) at 12 hours and 24 hours after surgery and post-operative recovery shall be noted in both the groups.

RICHMOND AGITATION SEDATION SCORE :

Limitations of Study are that study does not include age groups other than >60 yrs, patients with h/o neuro-cognitive disorders not included. Also, morbid obese patients with BMI >40 are not taken into count, and it is  a single hospital study.