Cognitive Dysfunction
Conditions
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.
Interventions
DRUGDexmedetomidine Injection
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.
Sponsors
Tata Main Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cases Developing POCD | 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
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Measured every 10 minutes upto 80 minutes, T0 as the initial reading. | Intraoperative Heart Rate |
| Any Adverse Outcome | 0-7 days | Observation for any adverse effects |
| Systolic Blood Pressure | Measured every 10 minutes upto 80 minutes, T0 as the initial reading. | Intraoperative Systolic Blood Pressure |
| Diastolic Blood Pressure | Measured every 10 minutes upto 80 minutes, T0 as the initial reading. | Intraoperative Diastolic Blood Pressure |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| CONTROL Group The Control Group will receive placebo infusion of normal saline. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | CONTROL Group | DEX Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 40 Participants | 41 Participants | 81 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 19 Participants | 39 Participants |
| Age, Continuous | 68.48 Years STANDARD_DEVIATION 4.96 | 68.28 Years STANDARD_DEVIATION 3.93 | 68.38 Years STANDARD_DEVIATION 4.46 |
| Race/Ethnicity, Customized Indian | 60 Participants | 60 Participants | 120 Participants |
| Sex: Female, Male Female | 29 Participants | 36 Participants | 65 Participants |
| Sex: Female, Male Male | 31 Participants | 24 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
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.
Time frame: 0-7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DEX Group | Number of Cases Developing POCD | 10 Participants |
| CONTROL Group | Number of Cases Developing POCD | 21 Participants |
Secondary
Any Adverse Outcome
Observation for any adverse effects
Time frame: 0-7 days
Population: Insidence of adverse outcomes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DEX Group | Any Adverse Outcome | 0 number of cases | Standard Deviation 0 |
| CONTROL Group | Any Adverse Outcome | 0 number of cases | Standard Deviation 0 |
Secondary
Diastolic Blood Pressure
Intraoperative Diastolic Blood Pressure
Time frame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
Population: Diastolic Blood Pressure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DEX Group | Diastolic Blood Pressure | T1 | 78.92 mmHg | Standard Deviation 9.06 |
| DEX Group | Diastolic Blood Pressure | T5 | 72.69 mmHg | Standard Deviation 7.78 |
| DEX Group | Diastolic Blood Pressure | T3 | 75.15 mmHg | Standard Deviation 9.34 |
| DEX Group | Diastolic Blood Pressure | T6 | 71.62 mmHg | Standard Deviation 7.35 |
| DEX Group | Diastolic Blood Pressure | T0 | 79.48 mmHg | Standard Deviation 9.38 |
| DEX Group | Diastolic Blood Pressure | T7 | 71.79 mmHg | Standard Deviation 6.97 |
| DEX Group | Diastolic Blood Pressure | T4 | 74.32 mmHg | Standard Deviation 8.44 |
| DEX Group | Diastolic Blood Pressure | T8 | 75.67 mmHg | Standard Deviation 5.51 |
| DEX Group | Diastolic Blood Pressure | T2 | 78.53 mmHg | Standard Deviation 7.61 |
| CONTROL Group | Diastolic Blood Pressure | T8 | 90.00 mmHg | Standard Deviation 0 |
| CONTROL Group | Diastolic Blood Pressure | T0 | 80.40 mmHg | Standard Deviation 8.59 |
| CONTROL Group | Diastolic Blood Pressure | T1 | 78.15 mmHg | Standard Deviation 11.19 |
| CONTROL Group | Diastolic Blood Pressure | T2 | 80.17 mmHg | Standard Deviation 8.96 |
| CONTROL Group | Diastolic Blood Pressure | T3 | 77.02 mmHg | Standard Deviation 10.28 |
| CONTROL Group | Diastolic Blood Pressure | T4 | 72.77 mmHg | Standard Deviation 10.48 |
| CONTROL Group | Diastolic Blood Pressure | T5 | 70.43 mmHg | Standard Deviation 11.96 |
| CONTROL Group | Diastolic Blood Pressure | T6 | 68.38 mmHg | Standard Deviation 10.06 |
| CONTROL Group | Diastolic Blood Pressure | T7 | 78 mmHg | Standard Deviation 7.81 |
Secondary
Heart Rate
Intraoperative Heart Rate
Time frame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
Population: Intraoperative heart rate
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DEX Group | Heart Rate | T6 | 74.76 Beats/minute | Standard Deviation 10.59 |
| DEX Group | Heart Rate | T4 | 76.32 Beats/minute | Standard Deviation 11.08 |
| DEX Group | Heart Rate | T1 | 74.80 Beats/minute | Standard Deviation 11.37 |
| DEX Group | Heart Rate | T5 | 76.15 Beats/minute | Standard Deviation 10.57 |
| DEX Group | Heart Rate | T0 | 75.00 Beats/minute | Standard Deviation 11.21 |
| DEX Group | Heart Rate | T7 | 70.17 Beats/minute | Standard Deviation 10.46 |
| DEX Group | Heart Rate | T2 | 79.8 Beats/minute | Standard Deviation 11.37 |
| DEX Group | Heart Rate | T8 | 69.33 Beats/minute | Standard Deviation 9.71 |
| DEX Group | Heart Rate | T3 | 77.97 Beats/minute | Standard Deviation 11.27 |
| CONTROL Group | Heart Rate | T8 | 95.00 Beats/minute | Standard Deviation 0 |
| CONTROL Group | Heart Rate | T2 | 82.02 Beats/minute | Standard Deviation 6.81 |
| CONTROL Group | Heart Rate | T0 | 81.90 Beats/minute | Standard Deviation 7.09 |
| CONTROL Group | Heart Rate | T1 | 82.02 Beats/minute | Standard Deviation 6.84 |
| CONTROL Group | Heart Rate | T3 | 82.65 Beats/minute | Standard Deviation 6.57 |
| CONTROL Group | Heart Rate | T4 | 83.20 Beats/minute | Standard Deviation 6.18 |
| CONTROL Group | Heart Rate | T6 | 85.35 Beats/minute | Standard Deviation 6.15 |
| CONTROL Group | Heart Rate | T7 | 86.67 Beats/minute | Standard Deviation 9.24 |
| CONTROL Group | Heart Rate | T5 | 84.00 Beats/minute | Standard Deviation 6.1 |
Secondary
Systolic Blood Pressure
Intraoperative Systolic Blood Pressure
Time frame: Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
Population: Intraoperative Systolic Blood Pressure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DEX Group | Systolic Blood Pressure | T1 | 130.78 mmHg | Standard Deviation 19.46 |
| DEX Group | Systolic Blood Pressure | T5 | 117.71 mmHg | Standard Deviation 10.73 |
| DEX Group | Systolic Blood Pressure | T3 | 126.22 mmHg | Standard Deviation 13.91 |
| DEX Group | Systolic Blood Pressure | T6 | 115.88 mmHg | Standard Deviation 10.65 |
| DEX Group | Systolic Blood Pressure | T2 | 128.22 mmHg | Standard Deviation 13.78 |
| DEX Group | Systolic Blood Pressure | T7 | 117.71 mmHg | Standard Deviation 10.96 |
| DEX Group | Systolic Blood Pressure | T4 | 122.93 mmHg | Standard Deviation 13.47 |
| DEX Group | Systolic Blood Pressure | T8 | 136.00 mmHg | Standard Deviation 5.29 |
| DEX Group | Systolic Blood Pressure | T0 | 129.07 mmHg | Standard Deviation 13.5 |
| CONTROL Group | Systolic Blood Pressure | T8 | 155.00 mmHg | Standard Deviation 0 |
| CONTROL Group | Systolic Blood Pressure | T0 | 125.4 mmHg | Standard Deviation 10.44 |
| CONTROL Group | Systolic Blood Pressure | T1 | 125.45 mmHg | Standard Deviation 10.81 |
| CONTROL Group | Systolic Blood Pressure | T2 | 127.48 mmHg | Standard Deviation 8.39 |
| CONTROL Group | Systolic Blood Pressure | T3 | 123.03 mmHg | Standard Deviation 8.6 |
| CONTROL Group | Systolic Blood Pressure | T4 | 119.1 mmHg | Standard Deviation 13.06 |
| CONTROL Group | Systolic Blood Pressure | T5 | 115.97 mmHg | Standard Deviation 11.43 |
| CONTROL Group | Systolic Blood Pressure | T6 | 113.5 mmHg | Standard Deviation 10.89 |
| CONTROL Group | Systolic Blood Pressure | T7 | 131.33 mmHg | Standard Deviation 15.31 |