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
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|
|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|
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.
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.
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)
- 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.
- 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
- 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
- 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
- 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
- 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
- Intra-operative awareness [ Time Frame: From the end of anaesthesia till 48-hours postoperatively ]Will be assessed using modified brice questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307551
|Contact: Nitin Sethi, DNBfirstname.lastname@example.org|
|Contact: Amitabh Dutta, MDemail@example.com|
|Sir Ganga Ram Hospital||Recruiting|
|New Delhi, Delhi, India, 110060|
|Contact: Nitin Sethi, DNB 00919717494498 firstname.lastname@example.org|
|Contact: Amitabh Dutta, MD 00919810848064 ext Dutta email@example.com|
|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|
|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|