Closed Loop Isoflurane Administration With Bispectral Index in Open Heart Surgery

This study has been completed.
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01069562
First received: February 1, 2010
Last updated: January 24, 2011
Last verified: July 2010
Results First Received: August 2, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject)
Condition: Open Heart Surgery
Interventions: Other: Conventional control
Other: Closed loop control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment of participants started on 10th January 2009 and ended on 24th June 2010. All patients recruited were admitted for elective cardiac surgery in the Cardio Thoracic Surgery ward in Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All the patients who were enrolled were randomized to the two study arms.

Reporting Groups
  Description
Manual The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
IAADS Group In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.

Participant Flow:   Overall Study
    Manual     IAADS Group  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Manual The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
IAADS Group In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
Total Total of all reporting groups

Baseline Measures
    Manual     IAADS Group     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     20     40  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.4  ± 15.2     46.4  ± 14.1     46.4  ± 14.5  
Gender  
[units: participants]
     
Female     6     4     10  
Male     14     16     30  
Region of Enrollment  
[units: participants]
     
India     20     20     40  



  Outcome Measures
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1.  Primary:   Percentage of Time Bispectral Index Remains Within 10 of Target BIS of 50   [ Time Frame: 8 hours (approximately) ]

2.  Secondary:   Median Performance Error (MDPE)   [ Time Frame: 8 hours (approximately) ]

3.  Secondary:   Median Absolute Performance Error (MDAPE)   [ Time Frame: 8 hours (approximately) ]

4.  Secondary:   Wobble   [ Time Frame: 8 hours (approximately) ]

5.  Secondary:   Percentage of Time Heart Rate Remained Within 25% of Pre-op Baseline   [ Time Frame: 8 hours (approximately) ]

6.  Secondary:   Percentage of Time Mean Arterial Pressure Remained Within 25% of Pre-op Baseline   [ Time Frame: 8 hours (approximately) ]

7.  Secondary:   Intra-operative Awareness   [ Time Frame: 3 days (approximately) ]

8.  Secondary:   Fentanyl Used   [ Time Frame: 8 hours (approximately) ]

9.  Secondary:   Intra Operative Adrenaline Used   [ Time Frame: 8 hours (approximately) ]

10.  Secondary:   INTRA OPERATIVE PHENYLEPHRINE USED   [ Time Frame: 8 hours (approximately) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Puri GD
Organization: Post Graduate Institute of Medical Education and Research
phone: 91-9914209509
e-mail: gdpuri007@hotmail.com


Publications:

Responsible Party: Prof G. D. Puri, Post Graduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01069562     History of Changes
Other Study ID Numbers: closed loop isoflurane
Study First Received: February 1, 2010
Results First Received: August 2, 2010
Last Updated: January 24, 2011
Health Authority: India: Institutional Review Board