Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

Tata Main Hospital120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

120

Conditions

Cognitive Dysfunction

Interventions

Dexmedetomidine InjectionDRUG

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Dr.Deb Sanjay Nag

Jamshedpur, Jharkhand, India

Outcomes

Primary Outcomes

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.

Time frame: 0-7 days

Secondary Outcomes

Systolic Blood Pressure

Intraoperative Systolic Blood Pressure

Time frame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.

Diastolic Blood Pressure

Intraoperative Diastolic Blood Pressure

Time frame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.

Heart Rate

Intraoperative Heart Rate

Time frame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.

Any Adverse Outcome

Observation for any adverse effects

Time frame: 0-7 days

Data from ClinicalTrials.gov

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