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NCT Number: NCT03793751

Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

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.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr.Deb Sanjay Nag

Jamshedpur, Jharkhand, 831011, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine Injection

Drug

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.

Other names: Normal Saline as placebo

Primary outcomes

  1. Number of Cases Developing POCD

    Time frame: 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 outcomes

  1. Systolic Blood Pressure

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

    Intraoperative Systolic Blood Pressure

  2. Diastolic Blood Pressure

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

    Intraoperative Diastolic Blood Pressure

  3. Heart Rate

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

    Intraoperative Heart Rate

  4. Any Adverse Outcome

    Time frame: 0-7 days

    Observation for any adverse effects

Sponsors and collaborators

Lead sponsor

Tata Main Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 4, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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