Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

Tata Main Hospital

Status and phase: Completed; Phase 4

Conditions: Cognitive Dysfunction

Treatments: Drug: Dexmedetomidine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03793751

201-26104-172-215441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

DEX Group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine Injection

CONTROL Group

Placebo Comparator group

Description:

The Control Group will receive an equal volume placebo infusion of normal saline.

Treatment:

Drug: Dexmedetomidine Injection