|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
IRCT |
|
Last refreshed on:
|
22 February 2018 |
|
Main ID: |
IRCT201104236266N1 |
|
Date of registration:
|
2011-05-09 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Target Controlled Infusion of Remifentanil with Propofol or Desflurane under Bispectral Index Guidence: quality of anesthesia and recovery profile
|
|
Scientific title:
|
Target Controlled Infusion of Remifentanil with Propofol or Desflurane under Bispectral Index Guidence: quality of anesthesia and recovery profile |
|
Date of first enrolment:
|
2009-04-01 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Complete |
|
URL:
|
http://en.irct.ir/trial/6711 |
|
Study type:
|
interventional |
|
Study design:
|
Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
|
|
Phase:
|
2
|
|
|
Countries of recruitment
|
|
Turkey
| | | | | | | |
|
Contacts
|
|
Name:
|
Ahmet Mahli
|
|
Address:
|
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation
06500
Ankara
Turkey |
|
Telephone:
|
+90 312 2024166 |
|
Email:
|
amahli@gazi.edu.tr |
|
Affiliation:
|
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation |
|
|
Name:
|
Ahmet Mahli
|
|
Address:
|
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation
06500
Ankara
Turkey |
|
Telephone:
|
+90 312 2024166 |
|
Email:
|
amahli@gazi.edu.tr |
|
Affiliation:
|
Gazi University Faculty of Medicine, Department of Anaesthesiology and Reanimation |
| |
|
Key inclusion & exclusion criteria
|
Inclusion 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
Exclusion criteria:
Age minimum:
18 years
Age maximum:
65 years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Other and unspecified general anaesthetics
|
Quality of anesthesia and recovery profile.
Other and unspecified general anaesthetics
|
|
Intervention(s)
|
|
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
|
|
Intervention 1: 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. Intervention 2: 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.
|
|
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
|
|
Treatment - Drugs
|
|
Primary Outcome(s)
|
|
Mean arterial pressure. Timepoint: During anesthesia. Method of measurement: Equipment.
|
|
Secondary Outcome(s)
|
|
Early emergence from anesthesia. Timepoint: During anesthesia. Method of measurement: Physical exam.
|
|
Heart rate. Timepoint: During anesthesia. Method of measurement: Physical exam.
|
|
Patients’ aldrete score (ARS). Timepoint: During anesthesia. Method of measurement: Physical exam.
|
|
Source(s) of Monetary Support
|
|
none
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
Institutional Ethics Committee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|