Our objective is to examine the clinical properties of two anesthetic regimens, propofol TCI or desflurane using remifentanil in a target-controlled infusion (TCI) under bispectral index (BIS) guidance during ear, nose, and throat (ENT) procedures. Forty consenting patients scheduled for ENT procedures will be prospectively studied, and they are included in one of the two groups: TCI (group TCI) or desflurane (group DES). General anaesthesia will be induced with 3 ng mL-1 and 4 µg mL-1 effect site concentrations (Ce) of remifentanil and propofol, respectively, with TCI system. After intubation, while propofol infusion is continued in the TCI group, it is ceased in the DES group and desflurane with an initial delivered fraction of 6 % is administered. The Ce of propofol infusion and inspired fraction of desflurane is adjusted in order to keep BIS 50 ± 10.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104236266N1
Registration date:2011-05-09, 1390/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-09, 1390/02/19
Registrant information
Name
Ahmet Mahli
Name of organization / entity
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation
Country
Turkey
Phone
+90 312 2024166
Email address
amahli@gazi.edu.tr
Recruitment status
Recruitment complete
Funding source
Gazi University
Expected recruitment start date
2009-04-01, 1388/01/12
Expected recruitment end date
2010-04-01, 1389/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Target Controlled Infusion of Remifentanil with Propofol or Desflurane under Bispectral Index Guidence: quality of anesthesia and recovery profile
Public title
Target Controlled Infusion of Remifentanil with Propofol or Desflurane under Bispectral Index Guidence: quality of anesthesia and recovery profile
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18-65 who are candidate for ENT procedures
Exclusion criteria:
Taking any sedative or analgesic drugs 24 hours before surgery, significantly hypertensive (diastolic blood pressure less than100 mmHg) or hypotensive (systolic blood pressure less 100 mmHg) and presence the signs of bradyarrhythmic heart disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Ethics Committee
Street address
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation
City
Ankara
Postal code
06500
Approval date
2009-03-01, 1387/12/11
Ethics committee reference number
01.03.2009
Health conditions studied
1
Description of health condition studied
Quality of anesthesia and recovery profile
ICD-10 code
Y48.2
ICD-10 code description
Other and unspecified general anaesthetics
Primary outcomes
1
Description
Mean arterial pressure
Timepoint
During anesthesia
Method of measurement
Equipment
Secondary outcomes
1
Description
Heart rate
Timepoint
During anesthesia
Method of measurement
Physical exam
2
Description
Early emergence from anesthesia
Timepoint
During anesthesia
Method of measurement
Physical exam
3
Description
Patients’ aldrete score (ARS)
Timepoint
During anesthesia
Method of measurement
Physical exam
Intervention groups
1
Description
TCI geoup; general anaesthesia will be induced with 3 ng mL-1 and 4 µg mL-1 effect site concentrations (Ce) of remifentanil and propofol
Category
Treatment - Drugs
2
Description
DES group; general anaesthesia will be induced with 3 ng mL-1 and 4 µg mL-1 effect site concentrations (Ce) of remifentanil and propofol, respectively, after intubation, propofol infusion is ceased in the DES group and desflurane with an initial delivered fraction of 6 % is administered
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation
Full name of responsible person
Street address
City
Ankara
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
none
Full name of responsible person
none
Street address
none
City
none
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
none
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation
Full name of responsible person
Ahmet Mahli
Position
Assistant Professor
Other areas of specialty/work
Street address
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation
City
Ankara
Province
none
Postal code
06500
Phone
+90 312 2024166
Fax
Email
amahli@gazi.edu.tr
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation
Full name of responsible person
Ahmet Mahli
Position
Assistant Professor
Other areas of specialty/work
Street address
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation
City
Ankara
Province
none
Postal code
06500
Phone
+90 312 2024166
Fax
Email
amahli@gazi.edu.tr
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Ahmet Mahli
Position
Other areas of specialty/work
Street address
City
Province
Postal code
Phone
Fax
Email
amahli@gazi.edu.tr
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)