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Completed

NCT Number: NCT03145714

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

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.

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Key information

Age range

58 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Anita Kulkarni, Delhi, India

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maintainance of anesthesia with Intravenous Propofol infusion

Drug

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

Maintainance of anesthesia with Intravenous Dexmedetomidine

Drug

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

Primary outcomes

  1. Postoperative Cognitive Dysfunction (POCD) after major noncardiac surgery under general anesthesia in Propofol and Dexmedetomidine Group

    Time frame: day 3 to day 7

    Postoperative Changes in Neuropsychological Tests Score compared with baseline preoperative Neuropsychological Test scores in both the groups.

Secondary outcomes

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

    Time frame: 30 seconds to 30 minutes.

    Time in seconds required for patients to respond to verbal commands on stopping the anesthetic agents in both groups.

Sponsors and collaborators

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Other

Registry information

Official study title

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

Acronym: POCD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 9, 2017
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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