Clincosm LogoSign in Get a demo

Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

Sponsor
Tata Main Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03793751
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
26
Actual Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexmedetomidine Injection
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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.
Primary Purpose:
Prevention
Official Title:
Effect of Intraoperative Dexmedetomidine Infusion on Early Postoperative Cognitive Dysfunction (POCD) in Geriatric Patients Undergoing Hip Surgery Under Spinal Anaesthesia
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: DEX Group

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.

Drug: Dexmedetomidine 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.
Other Names:
  • Normal Saline as placebo

    		•
    Placebo Comparator: CONTROL Group

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

    Drug: Dexmedetomidine 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.
    Other Names:
  • Normal Saline as placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Systolic Blood Pressure [Measured every 10 minutes upto 80 minutes, T0 as the initial reading.]

      Intraoperative Systolic Blood Pressure

    2. Diastolic Blood Pressure [Measured every 10 minutes upto 80 minutes, T0 as the initial reading.]

      Intraoperative Diastolic Blood Pressure

    3. Heart Rate [Measured every 10 minutes upto 80 minutes, T0 as the initial reading.]

      Intraoperative Heart Rate

    4. Any Adverse Outcome [0-7 days]

      Observation for any adverse effects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr.Deb Sanjay Nag Jamshedpur Jharkhand India 831011

    Sponsors and Collaborators

    • Tata Main Hospital

    Investigators

    • Principal Investigator: Dr.Deb S Nag, MD, Tata Main Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr.Deb Sanjay Nag, Consultant, Tata Main Hospital
    ClinicalTrials.gov Identifier:
    NCT03793751
    Other Study ID Numbers:
    • 201-26104-172-215441
    First Posted:
    Jan 4, 2019
    Last Update Posted:
    Apr 13, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Postoperative Cognitive Complications
    Cognitive Dysfunction
    Dexmedetomidine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title DEX Group CONTROL Group
    Arm/Group Description 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. The Control Group will receive placebo infusion of normal saline.
    Period Title: Overall Study
    STARTED 60 60
    COMPLETED 60 60
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title DEX Group CONTROL Group Total
    Arm/Group Description 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. The Control Group will receive placebo infusion of normal saline. Total of all reporting groups
    Overall Participants 60 60 120
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    19
    31.7%
    20
    33.3%
    39
    32.5%
    >=65 years
    41
    68.3%
    40
    66.7%
    81
    67.5%
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    68.28
    (3.93)
    68.48
    (4.96)
    68.38
    (4.46)
    Sex: Female, Male (Count of Participants)
    Female
    36
    60%
    29
    48.3%
    65
    54.2%
    Male
    24
    40%
    31
    51.7%
    55
    45.8%
    Race/Ethnicity, Customized (Count of Participants)
    Indian
    60
    100%
    60
    100%
    120
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Cases Developing POCD
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title DEX Group CONTROL Group
    Arm/Group Description 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. The Control Group will receive placebo infusion of normal saline.
    Measure Participants 60 60
    Count of Participants [Participants]
    10
    16.7%
    21
    35%
    2. Secondary Outcome
    Title Systolic Blood Pressure
    Description Intraoperative Systolic Blood Pressure
    Time Frame Measured every 10 minutes upto 80 minutes, T0 as the initial reading.

    Outcome Measure Data

    Analysis Population Description
    Intraoperative Systolic Blood Pressure
    Arm/Group Title DEX Group CONTROL Group
    Arm/Group Description 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. The Control Group will receive placebo infusion of normal saline.
    Measure Participants 60 60
    T0
    129.07
    (13.5)
    125.4
    (10.44)
    T1
    130.78
    (19.46)
    125.45
    (10.81)
    T2
    128.22
    (13.78)
    127.48
    (8.39)
    T3
    126.22
    (13.91)
    123.03
    (8.6)
    T4
    122.93
    (13.47)
    119.1
    (13.06)
    T5
    117.71
    (10.73)
    115.97
    (11.43)
    T6
    115.88
    (10.65)
    113.5
    (10.89)
    T7
    117.71
    (10.96)
    131.33
    (15.31)
    T8
    136.00
    (5.29)
    155.00
    (0)
    3. Secondary Outcome
    Title Diastolic Blood Pressure
    Description Intraoperative Diastolic Blood Pressure
    Time Frame Measured every 10 minutes upto 80 minutes, T0 as the initial reading.

    Outcome Measure Data

    Analysis Population Description
    Diastolic Blood Pressure
    Arm/Group Title DEX Group CONTROL Group
    Arm/Group Description 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. The Control Group will receive placebo infusion of normal saline.
    Measure Participants 60 60
    T0
    79.48
    (9.38)
    80.40
    (8.59)
    T1
    78.92
    (9.06)
    78.15
    (11.19)
    T2
    78.53
    (7.61)
    80.17
    (8.96)
    T3
    75.15
    (9.34)
    77.02
    (10.28)
    T4
    74.32
    (8.44)
    72.77
    (10.48)
    T5
    72.69
    (7.78)
    70.43
    (11.96)
    T6
    71.62
    (7.35)
    68.38
    (10.06)
    T7
    71.79
    (6.97)
    78
    (7.81)
    T8
    75.67
    (5.51)
    90.00
    (0)
    4. Secondary Outcome
    Title Heart Rate
    Description Intraoperative Heart Rate
    Time Frame Measured every 10 minutes upto 80 minutes, T0 as the initial reading.

    Outcome Measure Data

    Analysis Population Description
    Intraoperative heart rate
    Arm/Group Title DEX Group CONTROL Group
    Arm/Group Description 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. The Control Group will receive placebo infusion of normal saline.
    Measure Participants 60 60
    T0
    75.00
    (11.21)
    81.90
    (7.09)
    T1
    74.80
    (11.37)
    82.02
    (6.84)
    T2
    79.8
    (11.37)
    82.02
    (6.81)
    T3
    77.97
    (11.27)
    82.65
    (6.57)
    T4
    76.32
    (11.08)
    83.20
    (6.18)
    T5
    76.15
    (10.57)
    84.00
    (6.10)
    T6
    74.76
    (10.59)
    85.35
    (6.15)
    T7
    70.17
    (10.46)
    86.67
    (9.24)
    T8
    69.33
    (9.71)
    95.00
    (0)
    5. Secondary Outcome
    Title Any Adverse Outcome
    Description Observation for any adverse effects
    Time Frame 0-7 days

    Outcome Measure Data

    Analysis Population Description
    Insidence of adverse outcomes
    Arm/Group Title DEX Group CONTROL Group
    Arm/Group Description 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. The Control Group will receive placebo infusion of normal saline.
    Measure Participants 60 60
    Mean (Standard Deviation) [number of cases]
    0
    (0)
    0
    (0)

    Adverse Events

    Time Frame During the hospital admission upto 7 days after day of surgery
    Adverse Event Reporting Description 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.
    Arm/Group Title DEX Group CONTROL Group
    Arm/Group Description 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. The Control Group will receive placebo infusion of normal saline.
    All Cause Mortality
    DEX Group CONTROL Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/60 (0%)
    Serious Adverse Events
    DEX Group CONTROL Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/60 (0%)
    Other (Not Including Serious) Adverse Events
    DEX Group CONTROL Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/60 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr.Deb Sanjay Nag
    Organization Tata Main Hospital, Tata Steel
    Phone +91-9431166582
    Email debsanjay@gmail.com
    Responsible Party:
    Dr.Deb Sanjay Nag, Consultant, Tata Main Hospital
    ClinicalTrials.gov Identifier:
    NCT03793751
    Other Study ID Numbers:
    • 201-26104-172-215441
    First Posted:
    Jan 4, 2019
    Last Update Posted:
    Apr 13, 2020
    Last Verified:
    Apr 1, 2020