A Randomised clinical trial to compare effectiveness of ketofol and ketofol-dexmedetomidine group in patients undergoing modified electroconvulsive therapy.

Abstract

AIM: 1. To assess the hemodynamic fluctuations and seizure duration in patients receiving MECT using ketofol-dexmedetomedine and ketofol only. 2. To assess and compare their effects on cognitive function, severity of depression, mania and psychosis. BACKGROUND:  Modified Electro Convulsive Therapy (M.E.C.T.)is a well-established treatment for many psychiatric illnesses.  Anaesthesia is provided to prevent unfavoured effects associated with M.E.C.T., which include musculoskeletal injuries and agitation, confusion aggression in the early post-M.E.C.T. period.  Using ketofol and Dexmedetomidine aims to provide better quality by reducing the side effects mentioned above. METHODOLOGY  Preliminaries: ● Written informed consent was taken. ● Nil per oral status was confirmed. ● Intravenous access was secured with a 20 gauge cannula.  METHOD:In this prospective randomised clinical trial, 60 patients, aged 18 to 60 years of either sex, who were receiving M.E.C.T under General Anesthesia with ASA Grade I & II were randomly divided into two groups with 30 patients in group ketofol dexmedetomidine and 30 patients in group ketofol. The primary objective of the study was to assess and compare their effect on seizure duration ,changes in heart rate and blood pressure (systolic, diastolic). Secondary objectives of the study to assess and compare agitation, depression and effects on early post MECT complications like restlessness, and sedation of the two drugs studied. RESULTS:  Demographic profile regarding age, gender in both the groups were comparable and showed no significant results.  Compared to group KF, the majority of patients in group KFD achieved their goal MAP, HR and seizure duration with a minimum acceptable hemodynamic fluctuation, a minimal infusion of the study medication, reduced induction dosages of ketofol, and a shorter induction times.  Mean Hamilton Depression Rating score was lower in group KFD compared to KF group and it was statistically significant.  Mean MMSE scores before and after ECT are not statistically significant between the two groups.  Mean PANSS scores in schizophrenia patients before and after ECT are not statistically significant between the two groups.  The KFD and KF groups showed significantly different mean induction times (P value<0.001).The mean duration of motor seizures differed significantly between the KFD and KF groups (P-value<0.001).The mean total dose of induction differed significantly between the KFD and KF groups (P-value<0.001).The KFD group had a significantly lower and acceptable mean heart rate and mean arterial pressure than the KF group. CONCLUSION In comparison to ketofol, the combination of dexmedetomidine and ketofol for ECT is associated with a longer mean seizure time, effective anti-depressive effects, a lower incidence of agitation, an acceptable decrease in heart rate and blood pressure, and no significant side effects. Dexmedetomidine premedication is helpful in avoiding acute hyperdynamic responses to electroconvulsive therapy (ECT).