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

NCT03145714 | Completed

• 1 other identifier: RGCI&RC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

POCD; Elderly

Outcome Measures

Primary Outcomes (1)

• 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.

  day 3 to day 7

Secondary Outcomes (1)

• Recovery time from the stopping of anesthetics agents to eye opening in both Propofol and Dexmedetomidine Group

  30 seconds to 30 minutes.

Study Arms (2)

Propofol/Sevoflurane (Group P)

EXPERIMENTAL

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.

Drug: Maintainance of anesthesia with Intravenous Propofol infusion

Dexmedetomidine/Sevoflurane (Group D)

ACTIVE COMPARATOR

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.

Drug: Maintainance of anesthesia with Intravenous Dexmedetomidine

Interventions

Maintainance of anesthesia with Intravenous Propofol infusion DRUG

The dosage of Intravenous Propofol will be titrated to maintain BIS Values between 40 -60.

Propofol/Sevoflurane (Group P)

Maintainance of anesthesia with Intravenous Dexmedetomidine DRUG

The dosage of Intravenous Dexmedetomidine will be titrated to maintain BIS Values between 40 -60.

Dexmedetomidine/Sevoflurane (Group D)

Eligibility Criteria

• Age: 58 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rajiv Gandhi Cancer Institute & Research Center, India: lead

Study Sites (2)

Dr Anita Kulkarni

Delhi, 110078, India

Location

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, 110085, India

Location

Related Publications (3)

• 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.

  PMID: 20007989 BACKGROUND

• 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.

  PMID: 25187999 BACKGROUND

• 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.

  PMID: 25024467 BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Anita Kulkarni, M.D.

  Rajiv Gandhi Cancer Institue & Research Centre , Delhi, INDIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: May 9, 2017
• Study Start: June 1, 2017
• Primary Completion: February 10, 2018
• Study Completion: March 28, 2018
• Last Updated: February 4, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)