Effect of Intraoperative Dexmedetomidine on Early Postoperative Cognitive Dysfunction

NCT03793751 | Completed Phase 4 Results DMC

• 1 other identifier: 201-26104-172-215441
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Systolic Blood Pressure

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

• Diastolic Blood Pressure

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

• Heart Rate

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

• Any Adverse Outcome

  0-7 days

Study Arms (2)

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.

Drug: Dexmedetomidine Injection

CONTROL Group

PLACEBO COMPARATOR

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

Drug: Dexmedetomidine Injection

Interventions

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.

Also known as: Normal Saline as placebo

CONTROL Group; DEX Group

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American society of Anesthesiology (ASA) status of I-III
• Age between 60-75 years scheduled for elective hip surgery under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Main Hospital: lead

Study Sites (1)

Dr.Deb Sanjay Nag

Jamshedpur, Jharkhand, 831011, India

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr.Deb Sanjay Nag
• Organization: Tata Main Hospital, Tata Steel

debsanjay@gmail.com

+91-9431166582

Study Officials

• Dr.Deb S Nag, MD

  Tata Main Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: December 30, 2018
• First Posted: January 4, 2019
• Study Start: October 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 19, 2024
• Results First Posted: March 24, 2020

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)