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Trial record 3 of 14 for:    Recruiting, Not yet recruiting, Available Studies | "Thoracic Diseases"

Evaluation of Automated Propofol Delivery in Patients Undergoing Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT03307551
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Nitin Sethi, Sir Ganga Ram Hospital

Brief Summary:

Automated delivery of propofol using computer-controlled closed loop anaesthesia device delivers propofol based on patient's frontal cortex electrical activity as determined by bi-spectral index (BIS). Evaluation of anaesthesia delivery by these systems has shown that they deliver propofol and maintain depth of anaesthesia with far more precision as compared to manual administration.

By automatically controlling anaesthesia depth consistency they provide time to the anaesthesiologist to focus on other aspects of patient care such as managing intra-operative hemodynamics and ventilation perturbations during major surgeries.

Closed loop anaesthesia delivery system (CLADS) is an indigenously developed continuous automated intravenous infusion system which delivers propofol based on patients EEG profile (BIS) feedback. Although a few studies have already evaluated these automated systems in patients undergoing thoracic surgery, but suffered from significant limitations (small number of patients, not dedicated to thoracic surgery cohort). Currently, there is no data available regarding CLADS performance vis a vis adequacy of GA and haemodynamic profile in patients undergoing thoracic surgery.

We contend that propofol as delivered by CLADS will proffer greater consistency to anaesthesia depth, intra-operative hemodynamic stability, and rapid recovery upon anaesthesia discontinuation than manual means of delivering propofol TIVA. This randomised controlled study aims to compare the efficiency of CLADS-driven propofol TIVA versus manually controlled propofol TIVA in patients undergoing thoracic surgery.


Condition or disease Intervention/treatment Phase
Thoracic Diseases Surgery Drug: Propofol Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

30-patients aged 18-65 years, ASA physical status I-III, of either sex, and undergoing unilateral open thoracic surgery or unilateral video-assisted thoracic surgery (VATS) will randomly allocated by computer generated numbers to one of the following two groups of 15 patients each:

Group-1 [CLADS Group, n=15, Study group]: Anaesthesia will be induced and maintained with propofol administered using the automated CLADS.

Group-2 [Manual Group, n=15, Control group]: Anaesthesia will be induced and maintained with propofol administered using manually controlled infusion pumps titrated to BIS scores.

Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patient will be blinded to the type of anaesthesia intervention.The attending anaesthesiologist will however not be blinded to the technique utilized to administer GA and recovery immediately after extubation inside the OR. The postoperative patient recovery profile will be evaluated by an independent assessor blinded to the technique of GA.
Primary Purpose: Basic Science
Official Title: Evaluation of Automated Delivery of Propofol Using Closed-Loop Anaesthesia Delivery System in Patients Undergoing Thoracic Surgery: A Randomised Controlled Study
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Propofol

Arm Intervention/treatment
Active Comparator: CLADS group
Anaesthesia will be induced and maintained with Propofol administered by CLADS. Its administration rate will be controlled by a feedback loop facilitated by BIS monitoring. A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.
Drug: Propofol
Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient (CLADS group)

Active Comparator: Manual group
Anaesthesia will be induced and maintained with propofol administration by an intravenous infusion pump. Its administration rate will be controlled manually to maintain a target BIS of 50 during induction and maintenance of anaesthesia.
Drug: Propofol
Propofol delivery will be controlled using infusion pumps which will be manually controlled to deliver propofol to maintain consistent anaesthetic depth (BIS-50). (Manual group)




Primary Outcome Measures :
  1. Anaesthesia depth consistency using BIS scores [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively ]
    Determined by the percentage of the total anaesthesia time in which the BIS scores remain within a score of 10% of the target BIS (i.e. BIS-50) in both the study arms.


Secondary Outcome Measures :
  1. Evaluation of propofol anaesthesia delivery system [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively ]
    Determined by using Varvel criteria parameters; median performance error (MDP), median absolute performance error (MDAPE), wobble and global score in both the study arms

  2. Change in Intra-operative heart Rate (beats per minute) [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively ]
    Comparison of intra-operative heart rate between both the arms will be done

  3. Change in Intra-operative systolic , diastolic, and mean (mmHg) [ Time Frame: From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively ]
    Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done

  4. Recovery from anesthesia [ Time Frame: From end of anaesthesia till 20-minutes postoperatively] ]
    Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted

  5. Recovery from anesthesia [ Time Frame: From end of anaesthesia till 20-minutes postoperatively] ]
    Time taken for tracheal extubation after discontinuation of anaesthesia will be noted

  6. Intra-operative awareness [ Time Frame: From the end of anaesthesia till 48-hours postoperatively ]
    Will be assessed using modified brice questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status I-III
  • undergoing unilateral open thoracic surgery or unilateral video-assisted thoracic surgery (VATS) Exclusion Criteria:

Exclusion Criteria:

  • Uncompensated cardiovascular disease (e.g. uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction)
  • Hepato-renal insufficiency
  • Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism)
  • Known allergy/hypersensitivity to the study drug
  • Drug dependence/substance abuse
  • Requirement of postoperative ventilation
  • Refusal to informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307551


Contacts
Contact: Nitin Sethi, DNB 00919717494498 nitinsethi77@yahoo.co.in
Contact: Amitabh Dutta, MD 00919810848064 duttaamiatbh@yahoo.co.in

Locations
India
Sir Ganga Ram Hospital Recruiting
New Delhi, Delhi, India, 110060
Contact: Nitin Sethi, DNB    00919717494498    nitinsethi77@yahoo.co.in   
Contact: Amitabh Dutta, MD    00919810848064 ext Dutta    duttaamiatbh@yahoo.co.in   
Sub-Investigator: Goverdhan D Puri, MD,PhD         
Sub-Investigator: Bhuwan C Panday, MD         
Sub-Investigator: Jayashree Sood, MD,FFRCA         
Sub-Investigator: Shikha Sharma, MD         
Sub-Investigator: Manish Gupta, MD         
Principal Investigator: Nitin Sethi, DNB         
Principal Investigator: Amitabh Dutta, MD         
Sponsors and Collaborators
Dr Nitin Sethi
Investigators
Study Chair: Goverdhan D Puri, MD, PhD Post Graduate Institute of Medical Education & Research, Chandigarh, India
Study Director: Jayashree Sood, MD,FFRCA Sir Ganga Ram Hospital

Responsible Party: Dr Nitin Sethi, Associate Professor & Consultant, Sir Ganga Ram Hospital
ClinicalTrials.gov Identifier: NCT03307551     History of Changes
Other Study ID Numbers: EC/09/17/1254
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Dr Nitin Sethi, Sir Ganga Ram Hospital:
propofol, automated, manual

Additional relevant MeSH terms:
Thoracic Diseases
Respiratory Tract Diseases
Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General