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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEX Group | Experimental | 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. |
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| CONTROL Group | Placebo Comparator | The Control Group will receive an equal volume placebo infusion of normal saline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr.Deb S Nag, MD | Tata Main Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr.Deb Sanjay Nag | Jamshedpur | Jharkhand | 831011 | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | DEX Group | 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. |
| FG001 | CONTROL Group | The Control Group will receive placebo infusion of normal saline. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Geriatric patients of American Society of Anaesthesiology (ASA) status of I-III between 60-75 years scheduled for elective hip surgery under spinal anaesthesia.
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| ID | Title | Description |
|---|---|---|
| BG000 | DEX Group | 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. |
| BG001 | CONTROL Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 0-7 days |
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During the hospital admission upto 7 days after day of surgery
Common adverse effects of dexmedetomidine: Hypotension, hypertension, bradycardia, dry mouth and nausea. Other reported adverse effects include fever, rigors, cyanosis, muscle weakness. It may lead to arrhythmias, AV Block, cardiac arrest, T-wave inversion, tachycardia, angina pectoris, pulmonary edema, bronchospasm, respiratory depression, syncope, neuropathy, paresthesia, paresis, hyperkalaemia, lactic acidosis and hyperglycaemia.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DEX Group | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Deb Sanjay Nag | Tata Main Hospital, Tata Steel | +91-9431166582 | debsanjay@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2017 | Mar 10, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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This will be a prospective, randomized, placebo-controlled, double-blind clinical trial. The patients will be recruited according to the inclusion criteria and will be distributed to one of the groups according to computer-generated random assignment. The personnel involved in the study, including statisticians, investigators, anaesthetists, surgeons and the patients will be blinded to the specific experimental scheme implementation Patients will be randomized into one of the two groups using a computer based random number generator. https://www.randomizer.org. All recordings would be performed by an anaesthesiologist blinded to the group allocation.
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| 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 |
The Control Group will receive placebo infusion of normal saline. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | CONTROL Group | The Control Group will receive placebo infusion of normal saline. |
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| Secondary | Systolic Blood Pressure | Intraoperative Systolic Blood Pressure | Intraoperative Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Measured every 10 minutes upto 80 minutes, T0 as the initial reading. |
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| Secondary | Diastolic Blood Pressure | Intraoperative Diastolic Blood Pressure | Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Measured every 10 minutes upto 80 minutes, T0 as the initial reading. |
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| Secondary | Heart Rate | Intraoperative Heart Rate | Intraoperative heart rate | Posted | Mean | Standard Deviation | Beats/minute | Measured every 10 minutes upto 80 minutes, T0 as the initial reading. |
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| Secondary | Any Adverse Outcome | Observation for any adverse effects | Insidence of adverse outcomes | Posted | Mean | Standard Deviation | number of cases | 0-7 days |
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| 0 |
| 60 |
| 0 |
| 60 |
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| 60 |
| EG001 | CONTROL Group | The Control Group will receive placebo infusion of normal saline. | 0 | 60 | 0 | 60 | 0 | 60 |
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| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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