Study of the effects of maintaining remifentanil infusion until tracheal extubation on the recovery profile and hemodynamic variables in the patients with elective craniotomy
In a prospective randomized doubble blind clinical trial, 62 patients with ASA class I-II, undergoing elective supratentorial craniotomy surgery under general anaesthesia using total intravenous anesthesia (propofol and remifentanil) will be allocated randomly into two 31 patients group, case and control group, during emergence from anaesthesia. At the end of surgery, propofol will stop and the infusion of remifentanil will be stopped in the control group but maintained
in the remifentanil group with half maintenance dose until extubation. Heart rate (HR), mean arterial pressure (MAP), minogue scale and recovery profiles will be measured and copared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012110711398N1
Registration date:2013-05-04, 1392/02/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-04, 1392/02/14
Registrant information
Name
Mohammad Reza Ghodraty
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 6762
Email address
m-ghodrati@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of medicine faculty, Tehran University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-04-09, 1392/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of maintaining remifentanil infusion until tracheal extubation on the recovery profile and hemodynamic variables in the patients with elective craniotomy
Public title
Maintaining of remifentanil infusion until extubation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients who candidated to supratentorial craniotomy, Age from 18 to 65 years, ASA physical class I-II, preoperative GCS > 13
Eexclusion criteria: age> 65 <18 years, physical class ASA > II, GCS< 13, any allergy to the drugs of study, history of smoking, COPD, chronic cough, asthma, HTN, difficult airway and recent upper respiratory tract infections
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University Of Medical Sciences Ethics Committee
Street address
Tehran University Of Medical Sciences, Ghods St. Keshavarz Blvd.
City
tehran
Postal code
Approval date
2013-02-16, 1391/11/28
Ethics committee reference number
91/D/130/2999
Health conditions studied
1
Description of health condition studied
Craniotomy of supratentorial lesion
ICD-10 code
D33
ICD-10 code description
Brain, supratentorial
2
Description of health condition studied
Craniotomy of supratentorial lesion
ICD-10 code
C71
ICD-10 code description
تومور بدخیم مغز
3
Description of health condition studied
Craniotomy of supratentorial lesion
ICD-10 code
D43.0
ICD-10 code description
Brain, supratentorial
Primary outcomes
1
Description
coughing & bucking intensity
Timepoint
during tracheal extubation
Method of measurement
Minogue Scale
2
Description
Mean Arterial Pressure
Timepoint
Each 2 minutes from last skin suture or Mayfield opening until extubation and each 2 minutes after extubation until 10 minute later/each 5 minutes until 15 minute later in recovery room
Method of measurement
Automatic noninvasive sphigmomanumeter
3
Description
Heart rate
Timepoint
Each 2 minutes from last skin suture or Mayfield opening until extubation and each 2 minutes after extubation until 10 minute later/each 5 minutes until 15 minute later in recovery room
Method of measurement
Pulse oximeter
Secondary outcomes
1
Description
Time interval to awakening after discontinuing of anesthesia drug
Timepoint
Verbal stimulation every min after discontinuing of propofol
Method of measurement
Time to opening of eye with stimulation by cornometer
2
Description
Nausea & vomiting pervalance and intensity
Timepoint
Each 15 minutes until 1 hour in recovery room
Method of measurement
Four points score: 1 no sign, 2 mild, 3 moderate, 4 severe
3
Description
Concsiousness level
Timepoint
Each 15 minutes until 1 hour in recovery room
Method of measurement
GCS (Glasco coma scale)
4
Description
Reoperation incidance rate
Timepoint
Till 48 houres after operation
Method of measurement
Sergeon's decision
5
Description
Arrythemia incidance rate
Timepoint
After the last suture or Mayfield opening till O.R abondonment
Method of measurement
Contineous ECG monitoring
Intervention groups
1
Description
In the case group with last skin suture, infusion of propofol will be ceased but the infusion of remifentanil continued with the half dose of surgery time until response to verbal stimulation by patients.
Category
Prevention
2
Description
In the control group, with the conclusion of surgery both drugs (propofol & remifentanil) will be discontinued and for blinding infusion of normal saline as placebo will starts.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Mohammad Reza Ghodraty
Street address
Department of Anesthesiology, Firouzgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
2
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Amir Hossein Bagheri Aghdam MD.
Street address
Department of Anesthesiology, Rasoul-e-Akram HOspital, Niayesh St. Sattarkhan Av.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Medicine Faculty, Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhoundzadeh Basti MD.
Street address
Faculty of Medicine, Pour Sina Ave, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Medicine Faculty, Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Amir Hossein Bagheri Aghdam MD.
Position
Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiolgy Department, Firouzgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8214 1360
Fax
Email
homopersicus@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Firouzgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
m-ghodrati@tums.ac.ir mrghodrati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Ghodraty MD.
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology, Firouzgar Hospital, Beh-Afarin St. Karim Khan Av.
City
Tehran
Postal code
Phone
+98 21 8894 6762
Fax
Email
m-ghodrati@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)