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

Participant Flow

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
Arm/Group Description	Surgical patient group randomized t...	Surgical patient group randomized t...
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

Baseline Characteristics

Arm/Group Title		1 - SEDLine™ Group	2 - CONTROL Group	Total
Arm/Group Description		Surgical patient group randomized t...	Surgical patient group randomized t...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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
United States		32	35	67

Outcome Measures

1.Primary Outcome


Title	Time to Extubation
Description	The exact time from end of last anesthetic drug to time of tracheal ex...
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.

Outcome Measure Data

Analysis Population Description

All patients enrolled in both groups.


Arm/Group Title	1 - Sedline Group	2 - Control Group
Arm/Group Description:	Patient group randomized to active ...	Patient groups randomized to active...
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)

Adverse Events

Time Frame	1 day during anesthesia period
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	1 - SEDLine Group	Group 2 - Control Group
Arm/Group Description	Patient groups randomized to active...	Patient groups randomized to monito...
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	--/--	--/--
Serious Adverse Events 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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Drover DR, Schmiesing C, Buchin AF, Ortega HR, Tanner JW, Atkins JH, Macario A. Titration of sevoflurane in elderly patients: blinded, randomized clinical trial, in non-cardiac surgery after beta-adrenergic blockade. J Clin Monit Comput. 2011 Jun;25(3):175-81. doi: 10.1007/s10877-011-9293-1. Epub 2011 Aug 10.

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

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