Comparison of total intravenous and inhalational anesthesia effect on peri-operative blood glucose levels in diabetic patients undergoing gynecologic surgery
Surgeries may trigger the stress response. This response includes hemodynamic, metabolic, and hormonal changes which may alter the blood glucose level. The aim of this study, is to investigate the changes of blood glucose levels in diabetic patients and compare them in two methods of total intravenous (TIVA) or inhalational anesthesia. In this single center, randomized and double-blind clinical trial, diabetic patients with American society of anesthesiologists (ASA) class II or III, undergoing gynecologic surgery using two methods of total intravenous (study group) or inhalational (control group) anesthesia will be enrolled and patients with diabetic neuropathy or severe hepatic disorders will be excluded. The perioperative blood glucose levels was considered the primary endpoint, and was used to estimate the sample size. It was calculated that sample size of 30 patients in each group. Blood glucose levels, vital signs, and hemodynamic data were assessed prior to the surgery incision and each 30 min during surgery, until the end of operation and in the post anesthesia care unit (PACU). Perioperative complications also are recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608187013N13
Registration date:2016-10-20, 1395/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-20, 1395/07/29
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-08-15, 1395/05/25
Expected recruitment end date
2017-04-13, 1396/01/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of total intravenous and inhalational anesthesia effect on peri-operative blood glucose levels in diabetic patients undergoing gynecologic surgery
Public title
Effect of anesthesia method on peri-operative blood glucose levels in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients candidate to gynecologic surgery; patients undergoing general anesthesia with endotracheal intubation. Exclusion criteria: Emergence surgery; history of renal disease due to diabetic neuropathy; history of hepatic disease; history of allergy to propofol; history of steroid or beta adrenergic therapy
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using sealed envelope method, patients were randomly assigned to study group (n = 30), and control group (n = 30)
using a computer-generated randomization list. The study is designed double blinded and none of the patients know about their anesthetic medications, as well as one researcher unaware of cases and grouping, fills checklists. An anesthesiologist is aware of the number of cases and grouping, and also the anesthetic medications.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the research and technology department, Tabriz University of Medical sciences
Street address
Vice Chancellor for Research, Building No. 2 Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Approval date
2016-08-02, 1395/05/12
Ethics committee reference number
IR.TBZMED.REC.1395.403
Health conditions studied
1
Description of health condition studied
Perioperative blood glocuse levels
ICD-10 code
T88.7
ICD-10 code description
Unspecified adverse effect of drug or medicament
Primary outcomes
1
Description
Blood glocuse lavels
Timepoint
Prior to induction of anesthesia, after surgical incision, every 30 min until the end of surgery, and in post anesthesia care unit (PACU)
Method of measurement
By glucometer
Secondary outcomes
1
Description
Perioperative complications such as hypoglycemia, nausea, myocardial infarction and etc.
Timepoint
Intraoperative and during 24 hours after operation
Method of measurement
Clinical document
Intervention groups
1
Description
In study group: after the standard induction of general anesthesia, for maintenance of anesthesia، intravenous anesthetics will be administered (infusion of propofol 50-150 microgram per kilogram body weight in minute and remifentanil 0.1-1 microgram per kilogram body weight in minute combined with 100 precent oxygen).
Category
Treatment - Other
2
Description
In control group: after the standard induction of general anesthesia, for maintenance of anesthesia inhalation anesthetics will be administered (isoflurane 0.5-1 MAC and 50 percent nitrous oxide in oxygen).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Medical Education Center
Full name of responsible person
Dr. Simin Atashkhoei
Street address
Al-Zahra Hospital, Sought Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Scienses
Full name of responsible person
Dr. Rashidi
Street address
Vice chancellor for research, Building No. 2 Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tabriz University of Medical Scienses
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
Vice Chancellor for Research, Tabriz University of Medicalُ Sciences
Full name of responsible person
Dr. Simin Atashkhoei
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice Chancellor for Research,Tabriz university of Medical sciences
Full name of responsible person
Dr. Simin Atashkhoei
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoei
Position
Anesthesiologist/Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital, South Artesh Street
City
Tabriz
Postal code
Phone
00
Fax
Email
satashkhoyi@gmail.com siminatashkhoii@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)