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To Study the Effect of Sevoflurane and Propofol V Sevoflurane and Dexmedetomidine on Postoperative Cognitive Dysfunction (POCD)

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Maintainance of anesthesia with Intravenous Propofol infusion
Maintainance of anesthesia with Intravenous Dexmedetomidine
Sponsored by
Rajiv Gandhi Cancer Institute & Research Center, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Cognitive Dysfunction focused on measuring POCD, Elderly

Eligibility Criteria

58 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient subjected to general anaesthesia for elective noncardiac surgical procedure with duration above 2 hours and postoperative stay for 3 days. Patient should be available for follow up on 7 th postoperative day.

Exclusion Criteria:

  • Patients having severe psychosis on antidepressant medications, cerebral disease, pre-existing cognitive dysfunction with Mini Mental State Examination (MMSE) Score less than 23, history of drug abuse, significant visual and hearing impairment ,language difficulties and illiteracy.

Sites / Locations

  • Dr Anita Kulkarni
  • Rajiv Gandhi Cancer Institute and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Propofol/Sevoflurane (Group P)

Dexmedetomidine/Sevoflurane (Group D)

Arm Description

Standard technique of induction of anaesthesia . Maintenance of anesthesia with intravenous (IV) Propofol Infusion at rate 100-150 mcg/kilogram/hour and Inhalational Anesthetic Sevoflurane during the surgery. Intervention is to titrate dosage of Propofol and Sevoflurane to maintain Bispectral Index between 40-60. Total dosage of IV Propofol and Sevoflurane uptake will be calculated at the end of surgery.

Standard technique of induction of anaesthesia . Maintenance of anesthesia with intravenous Dexmedetomidine Infusion at rate 1- 4 mcg/kilogram/hour and Inhalational Anesthetic Sevoflurane during the surgery. Intervention is to titrate dosage of Dexmedetomidine and Sevoflurane to maintain Bispectral Index between 40 - 60. Total dosage of IV Dexmedetomidine and Sevoflurane uptake will be calculated at the end of surgery.

Outcomes

Primary Outcome Measures

Postoperative Cognitive Dysfunction (POCD) after major noncardiac surgery under general anesthesia in Propofol and Dexmedetomidine Group
Postoperative Changes in Neuropsychological Tests Score compared with baseline preoperative Neuropsychological Test scores in both the groups.

Secondary Outcome Measures

Recovery time from the stopping of anesthetics agents to eye opening in both Propofol and Dexmedetomidine Group
Time in seconds required for patients to respond to verbal commands on stopping the anesthetic agents in both groups.

Full Information

First Posted
March 7, 2017
Last Updated
January 31, 2019
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
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1. Study Identification

Unique Protocol Identification Number
NCT03145714
Brief Title
To Study the Effect of Sevoflurane and Propofol V Sevoflurane and Dexmedetomidine on Postoperative Cognitive Dysfunction
Acronym
POCD
Official Title
To Study the Effect of Sevoflurane and Propofol Versus Sevoflurane and Dexmedetomidine on Postoperative Cognitive Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
February 10, 2018 (Actual)
Study Completion Date
March 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Postoperative Cognitive Dysfunction (POCD), is a subtle decline in cognitive function characterized by impairment of memory and reduced ability to concentrate in elderly patients exposed to general anaesthesia. This prospective study aims to compare incidence and severity of POCD in two groups of patients. Group P receiving Intravenous Propofol and Inhalational anesthetic Sevoflurane. Group D receiving Intravenous Dexmedetomidine and Inhalational anesthetic Sevoflurane, Neuropsychological Test will be performed 24 hours before surgery and on postoperative day 3 and day 7.
Detailed Description
The adult patients posted for major surgery under general anesthesia will be included in the study, patients will be allotted randomly to either Group P (Propofol) or Group D (Dexmedetomidine). In the Operation Room (OR) monitoring Electrocardiography (ECG), Pulse Oximetry (SPO2), Noninvasive Blood Pressure (NIBP), End tidal Carbon di oxide (ETCO2) and Bispectral Index (BIS) Covidien, will be attached to all patients. In both groups Anesthesia will be induced with Fentanyl 1mcg /kg-1, Morphine 0.1mg/kg-1, Propofol 1-1.5mg /kg1- and neuromuscular blocking agent Atracurium 0.5 mg/kg-1. Oral Cuffed Endotracheal Tube (ETT) will be placed in the trachea. Anaesthesia will be maintained controlled ventilation , intermittent fentanyl boluses 20 mcg and in Group P with medicated Air/Oxygen (O2) with Fractional Inspired Oxygen (FiO2 50%), Sevoflurane and Propofol Infusion to maintain BIS between 40-60. In Group D anesthesia will be maintained with Medicated Air/Oxygen (FiO2 50%), Sevoflurane and Dexmedetomidine infusion to maintain BIS between 40-60. Intraoperatively monitoring of vitals, BIS numerical value, Minimum Alveolar Concentration (MAC) Value for Sevoflurane, Expired concentration of Sevoflurane and rate of infusion of Propofol/Dexmedetomidine will be noted every 30 minutes. Intraoperative decrease in Mean Arterial Pressure (MAP) < 60 mmHg, Heart rate (HR) < 50, SPO2 < 90 % will also be noted. At the end of surgery total dosage of Propofol/Dexmedetomidine and total amount of Sevoflurane consumed will be calculated. At the end of surgery neuromuscular blockade will be reversed. Total Duration of anesthesia will be noted. On emergence from anesthesia any episode of acute delirium will be recorded. Time from end of anesthesia to eye opening will be noted in both the groups. Neuropsychological Test consisting of Letter Digit Substitution Test, Trail Making Test Part A, Part B, Stroop Colour Word Test, Visual Verbal Learning Test will be performed 24 hours prior to surgery in the preanesthesia clinic and on postoperative day 3 and day 7.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
POCD, Elderly

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol/Sevoflurane (Group P)
Arm Type
Experimental
Arm Description
Standard technique of induction of anaesthesia . Maintenance of anesthesia with intravenous (IV) Propofol Infusion at rate 100-150 mcg/kilogram/hour and Inhalational Anesthetic Sevoflurane during the surgery. Intervention is to titrate dosage of Propofol and Sevoflurane to maintain Bispectral Index between 40-60. Total dosage of IV Propofol and Sevoflurane uptake will be calculated at the end of surgery.
Arm Title
Dexmedetomidine/Sevoflurane (Group D)
Arm Type
Active Comparator
Arm Description
Standard technique of induction of anaesthesia . Maintenance of anesthesia with intravenous Dexmedetomidine Infusion at rate 1- 4 mcg/kilogram/hour and Inhalational Anesthetic Sevoflurane during the surgery. Intervention is to titrate dosage of Dexmedetomidine and Sevoflurane to maintain Bispectral Index between 40 - 60. Total dosage of IV Dexmedetomidine and Sevoflurane uptake will be calculated at the end of surgery.
Intervention Type
Drug
Intervention Name(s)
Maintainance of anesthesia with Intravenous Propofol infusion
Intervention Description
The dosage of Intravenous Propofol will be titrated to maintain BIS Values between 40 -60.
Intervention Type
Drug
Intervention Name(s)
Maintainance of anesthesia with Intravenous Dexmedetomidine
Intervention Description
The dosage of Intravenous Dexmedetomidine will be titrated to maintain BIS Values between 40 -60.
Primary Outcome Measure Information:
Title
Postoperative Cognitive Dysfunction (POCD) after major noncardiac surgery under general anesthesia in Propofol and Dexmedetomidine Group
Description
Postoperative Changes in Neuropsychological Tests Score compared with baseline preoperative Neuropsychological Test scores in both the groups.
Time Frame
day 3 to day 7
Secondary Outcome Measure Information:
Title
Recovery time from the stopping of anesthetics agents to eye opening in both Propofol and Dexmedetomidine Group
Description
Time in seconds required for patients to respond to verbal commands on stopping the anesthetic agents in both groups.
Time Frame
30 seconds to 30 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
58 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient subjected to general anaesthesia for elective noncardiac surgical procedure with duration above 2 hours and postoperative stay for 3 days. Patient should be available for follow up on 7 th postoperative day. Exclusion Criteria: Patients having severe psychosis on antidepressant medications, cerebral disease, pre-existing cognitive dysfunction with Mini Mental State Examination (MMSE) Score less than 23, history of drug abuse, significant visual and hearing impairment ,language difficulties and illiteracy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Kulkarni, M.D.
Organizational Affiliation
Rajiv Gandhi Cancer Institue & Research Centre , Delhi, INDIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Anita Kulkarni
City
Delhi
ZIP/Postal Code
110078
Country
India
Facility Name
Rajiv Gandhi Cancer Institute and Research Centre
City
Delhi
ZIP/Postal Code
110085
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20007989
Citation
Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.
Results Reference
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PubMed Identifier
25187999
Citation
Akeju O, Pavone KJ, Westover MB, Vazquez R, Prerau MJ, Harrell PG, Hartnack KE, Rhee J, Sampson AL, Habeeb K, Gao L, Pierce ET, Walsh JL, Brown EN, Purdon PL. A comparison of propofol- and dexmedetomidine-induced electroencephalogram dynamics using spectral and coherence analysis. Anesthesiology. 2014 Nov;121(5):978-89. doi: 10.1097/ALN.0000000000000419. Erratum In: Anesthesiology. 2015 Apr;122(4):958. Lei, Gao [corrected to Gao, Lei].
Results Reference
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PubMed Identifier
25024467
Citation
Kotekar N, Kuruvilla CS, Murthy V. Post-operative cognitive dysfunction in the elderly: A prospective clinical study. Indian J Anaesth. 2014 May;58(3):263-8. doi: 10.4103/0019-5049.135034.
Results Reference
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To Study the Effect of Sevoflurane and Propofol V Sevoflurane and Dexmedetomidine on Postoperative Cognitive Dysfunction

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