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Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

Primary Purpose

Cognitive Dysfunction

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Dexmedetomidine Injection
Sponsored by
Tata Main Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Dysfunction

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dr.Deb Sanjay Nag

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DEX Group

CONTROL Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Systolic Blood Pressure
Intraoperative Systolic Blood Pressure
Diastolic Blood Pressure
Intraoperative Diastolic Blood Pressure
Heart Rate
Intraoperative Heart Rate
Any Adverse Outcome
Observation for any adverse effects

Full Information

First Posted
December 30, 2018
Last Updated
April 6, 2020
Sponsor
Tata Main Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03793751
Brief Title
Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction
Official Title
Effect of Intraoperative Dexmedetomidine Infusion on Early Postoperative Cognitive Dysfunction (POCD) in Geriatric Patients Undergoing Hip Surgery Under Spinal Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tata Main Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEX Group
Arm Type
Experimental
Arm 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.
Arm Title
CONTROL Group
Arm Type
Placebo Comparator
Arm Description
The Control Group will receive an equal volume placebo infusion of normal saline.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Injection
Other Intervention Name(s)
Normal Saline as placebo
Intervention 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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
Intraoperative Systolic Blood Pressure
Time Frame
Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
Title
Diastolic Blood Pressure
Description
Intraoperative Diastolic Blood Pressure
Time Frame
Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
Title
Heart Rate
Description
Intraoperative Heart Rate
Time Frame
Measured every 10 minutes upto 80 minutes, T0 as the initial reading.
Title
Any Adverse Outcome
Description
Observation for any adverse effects
Time Frame
0-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Deb S Nag, MD
Organizational Affiliation
Tata Main Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr.Deb Sanjay Nag
City
Jamshedpur
State/Province
Jharkhand
ZIP/Postal Code
831011
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

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