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Using the SEDLine for the Titration of Sevoflurane in Elderly Patients Recovery Using the SEDLine TM for the Titration of Sevoflurane in Elderly Patients Undergoing Non-Cardiac Surgery After Beta-Adrenergic Blockade

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ClinicalTrials.gov Identifier: NCT00938782
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : February 19, 2015
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
David R. Drover, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Anesthesia, General
Intervention Device: Sedline
Enrollment 67
Recruitment Details Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups.
Pre-assignment Details  
Arm/Group Title 1 - SEDLine™ Group 2- Control Group
Hide Arm/Group Description Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor. Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.
Period Title: Overall Study
Started 32 [1] 35 [2]
Completed 32 [3] 35 [3]
Not Completed 0 0
[1]
Pre-induction of anesthesia
[2]
Monitoring started pre-induction of anesthesia
[3]
Upon discharge from PACU
Arm/Group Title 1 - SEDLine™ Group 2 - CONTROL Group Total
Hide Arm/Group Description

Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.

Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was based on SEDLine™ data (SEDLine™ group).

Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.

Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was not based on SEDLine™ data (CONTROL group)

Total of all reporting groups
Overall Number of Baseline Participants 32 35 67
Hide Baseline Analysis Population Description
Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 35 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
32
 100.0%
35
 100.0%
67
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 35 participants 67 participants
75  (5.7) 74.5  (6.7) 74.8  (6.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 35 participants 67 participants
Female
12
  37.5%
11
  31.4%
23
  34.3%
Male
20
  62.5%
24
  68.6%
44
  65.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 35 participants 67 participants
32 35 67
1.Primary Outcome
Title Time to Extubation
Hide Description The exact time from end of last anesthetic drug to time of tracheal extubation.
Time Frame Measured from time of end anesthesia to time of tracheal extubation.
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in both groups.
Arm/Group Title 1 - Sedline Group 2 - Control Group
Hide Arm/Group Description:
Patient group randomized to active monitoring with Sedline monitor.
Patient groups randomized to active monitoring versus blinded monitoring. This group had teh clinician blinded to output of the Sedline monitor.
Overall Number of Participants Analyzed 32 35
Mean (Standard Deviation)
Unit of Measure: minutes
13.0  (5.9) 12.5  (7.4)
Time Frame 1 day during anesthesia period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 - SEDLine Group Group 2 - Control Group
Hide Arm/Group Description Patient groups randomized to active monitoring. This group had Sedline monitor used to titrate anesthesia. Patient groups randomized to monitoring with blinded data not used to titrate anesthesia.
All-Cause Mortality
1 - SEDLine Group Group 2 - Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
1 - SEDLine Group Group 2 - Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/35 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 - SEDLine Group Group 2 - Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David R Drover
Organization: Stanford University
Phone: 650-725-0364
EMail: ddrover@stanford.edu
Layout table for additonal information
Responsible Party: David R. Drover, Stanford University
ClinicalTrials.gov Identifier: NCT00938782    
Other Study ID Numbers: SU-11062007-818
First Submitted: July 10, 2009
First Posted: July 14, 2009
Results First Submitted: January 23, 2015
Results First Posted: February 19, 2015
Last Update Posted: February 19, 2015