Clinical trial NCT03793751: Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction
Official title: Effect of Intraoperative Dexmedetomidine Infusion on Early Postoperative Cognitive Dysfunction (POCD) in Geriatric Patients Undergoing Hip Surgery Under Spinal Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cognitive Dysfunction
Lead sponsor: Tata Main Hospital
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Cases Developing POCD
timeFrame: 0-7 days
Secondary outcomes:
measure: Systolic Blood Pressure
timeFrame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
measure: Diastolic Blood Pressure
timeFrame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
measure: Heart Rate
timeFrame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
measure: Any Adverse Outcome
timeFrame: 0-7 days
Other outcomes:
Locations:
city: Jamshedpur
country: India
facility: Dr.Deb Sanjay Nag
state: Jharkhand
Study officials:
affiliation: Tata Main Hospital
name: Dr.Deb S Nag, MD
role: PRINCIPAL_INVESTIGATOR
References: