Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

Phase 4

Completed

Brief Summary: This study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years undergoing hip surgery under spinal anaesthesia.

Detailed Description: Postoperative cognitive dysfunction (POCD) is a common postoperative neurological complication in elderly. POCD is a subtle impairment of memory, concentration and information processing with clinical manifestations of delirium, anxiety, personality changes and impaired memory, which is associated with prolonged hospitalization, a reduced quality of life and an increase in morbidity and mortality. Dexmedetomidine is a highly selective α-2 adrenergic receptor agonist with a dose-dependent sedative hypnotic effect. It has also been reported that dexmedetomidine has a potential role in preventing POCD due to its neuroprotective effects both in vitro and in vivo.

Till date very few studies have analysed the impact of dexmedetomidine on early POCD. Even in the few available studies compared assessment of POCD using the Mini-Mental State Examination (MMSE) scores and found that MMSE have lower sensitivity for identifying Cognitive Dysfunction as compared to Montreal Cognitive Assessment (MoCA). The study would analyze the impact of Intraoperative Dexmedetomidine infusion on early Postoperative Cognitive Dysfunction (POCD) in geriatric patients above 60 years undergoing hip surgery under spinal anesthesia.

So this study will aim to identify the impact of Intraoperative dexmedetomidine infusion on POCD assessed by the Montreal Cognitive Assessment (MoCA) in geriatric patients above 60 years undergoing hip surgery under spinal anaesthesia.

Recruitment & Eligibility

Inclusion Criteria

American society of Anesthesiology (ASA) status of I-III
Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia

Exclusion Criteria

Patient not willing to be a part of the study
Patients were aged <60 or >75 years
Patients with accompanying medical conditions that may affect the level of consciousness, such as stroke, stupor or dementia, or patients with abnormalities in hepatic or renal function, electrolyte imbalance
Patients suffering from preoperative bradycardia [heart rate (HR) <60 bpm] or hypotension [mean arterial blood pressure (MAP) <70 mmHg]
Patients who had recently received a sedative or opioid drug
Patients with a MoCA (Montreal Cognitive Assessment) score <26
Patients with persistent hypotension and bradycardia intra-operatively even after giving Mephentermine will be excluded from the study

Arm && Interventions

Group	Intervention	Description
DEX Group	Dexmedetomidine Injection	Receiving Dexmedetomidine injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
CONTROL Group	Dexmedetomidine Injection	The Control Group will receive an equal volume placebo infusion of normal saline.

Primary Outcome Measures

Name	Time	Method
Number of Cases Developing POCD	0-7 days	Number of cases developing POCD in the Dexmedetomidine Group as compared to the placebo group using the Montreal Cognitive Assessment (MoCA) test. The "Montreal Cognitive Assessment" (MoCA) test is a free assessment available at http://www.mocatest.org tool designed for quick screening for mild cognitive impairment. It is a one page, 30 point test done in approximately 10 min for assessment of attention, memory, abstraction, delayed recall and orientation, with total score of 30. MoCA range from zero to 30, with a score of 26 and higher generally considered normal. Scores below 26 were considered as Postoperative Cognitive Dysfunction.

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	Measured every 10 minutes upto 80 minutes, T0 as the initial reading.	Intraoperative Systolic Blood Pressure
Diastolic Blood Pressure	Measured every 10 minutes upto 80 minutes, T0 as the initial reading.	Intraoperative Diastolic Blood Pressure
Heart Rate	Measured every 10 minutes upto 80 minutes, T0 as the initial reading.	Intraoperative Heart Rate
Any Adverse Outcome	0-7 days	Observation for any adverse effects