Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Intraoperative Dexmedetomidine Infusion on Early Postoperative Cognitive Dysfunction (POCD) in Geriatric Patients Undergoing Hip Surgery Under Spinal Anaesthesia

Conditions
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Cognitive Dysfunction

Intervention / Treatment
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* Drug: Dexmedetomidine Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEX Group<br>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. | Drug: Dexmedetomidine Injection<br>* 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.<br>* Other names: Normal Saline as placebo;|
| Placebo Comparator: CONTROL Group<br>The Control Group will receive an equal volume placebo infusion of normal saline. | Drug: Dexmedetomidine Injection<br>* 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.<br>* Other names: Normal Saline as placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Cases Developing POCD | 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. | 0-7 days | 

Secondary Outcome Measures

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