Protocol summary

Summary
Objectives: The study aimed to investigate the methods for better and less awakening complication in the patients by comparing two general anesthesia (the gas isoflurane anesthesia and mixture injection of propofol and alfentanil). Study design: Double-blind for the patients and investigators, randomized , one trial study. Study setting and conduct: All patients will be under the same conditions of induction of general anesthesia and mechanical ventilation. In the two groups, two different drug will use to sustain anesthesia. The studied patients in two stages will be under the investigation. The standard questionnaire designed by Brice., 1970 will use by people who are unaware of the type of used drugs to assess the presence of awareness during anesthesia. Participants including major eligibility criteria: Volunteer surgery patients in the age group 16 to 70 years old. Major exclusive criteria: Patients which before anesthesia does not able to speak;patients who are not able to talk in the recovery room after anesthesia;severely ill;suspected under coma patients which brought to the operating room; patients with less than 4 hours staying after surgery in the hospital; mental illness and those who are taking psychiatric drugs. Sample: Two groups of 200 patients. Interventions: The first group to sustain anesthetic will inhale isoflurane gas and the second group will inject such mixture of the proposal and alfentanil. The intervening time: After induction of general anesthesia and mechanical ventilation in the operation room. Variable of main outcome: Intraoperative awakening is an independent continual variable and drugs are as the independent nominal variant.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016012826234N1
Registration date: 2016-06-10, 1395/03/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-10, 1395/03/21
Registrant information
Name
Forough Rasekhi
Name of organization / entity
University Of Medical Sciences Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 937 928 3620
Email address
rasekhif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences Shiraz(international branch).
Expected recruitment start date
2016-05-09, 1395/02/20
Expected recruitment end date
2016-07-10, 1395/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The cumulative incidence of awareness during anesthesia comparing isoflorane - based versus propofol with alfentanil (TIVA) anesthesia
Public title
The cumulative incidence of awareness during anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age group 16 to 70 years; all in ASA class III, II, Ι . Exclusion criteria: Patients under 16 and over 70 years; patients before anesthesia, does not have full consciousness or not able to speak; Patients in the recovery room after anesthesia was not able to talk;Very ill patients with suspected and coma brought to the operating room;Patients who develop postoperative hospital stay of less than 4 hours;Mental illness and those who are taking psychiatric drugs.
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 400
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Medical Sciences Shiraz(international branch)
Street address
University of Mdical Sience Shiraz(international branch),injuries and burn hospital entrance, 3rd km of sadra road
City
Shiraz
Postal code
00987144716699
Approval date
2016-03-06, 1394/12/16
Ethics committee reference number
IR.SUMS.RET.1394.220

Health conditions studied

1

Description of health condition studied
History of intraoperative awareness under general anesthesia
ICD-10 code
Z91.89
ICD-10 code description
Personal history of other specified risk-factors, not elsewhere classified

Primary outcomes

1

Description
Awareness during anesthesia
Timepoint
In two stages (in the recovery room and 4 hours after the end of the operation) will be under the investigation
Method of measurement
The standard questions designed by Brice., 1970 will use to assess the presence of awareness during anesthesia

2

Description
The pain feeling during anesthesia
Timepoint
In two stages (in the recovery room and 4 hours after the end of the operation) will be under the investigation
Method of measurement
The standard questions designed by Brice., 1970 will use to assess the presence of awareness during anesthesia

Secondary outcomes

1

Description
Duration of surgery
Timepoint
In the operation room.
Method of measurement
the standard question designed by Brice., 1970 will use to assess the presence of awareness during anesthesia

Intervention groups

1

Description
The first group Isofloran: 0.5-1 percent gas inhalation. After general anesthesia.
Category
Prevention

2

Description
The second group Mixture of propofol and alfentanil: 100 μg / kg / min of Propofol and 1.5 μg/kg/min of Alfentanil. injection after general anesthesia.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Motahhari Hospital
Full name of responsible person
Hamidreza Bahmani
Street address
Shahid Motahhari Hospital,Moallem sq.Marvdasht
City
Marvdasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Medical Sciences Shiraz (International Branch)
Full name of responsible person
Mohammad Foroutan
Street address
Department of Anesthesiology,Shahid Motahhari Hospital,Moallem sq,Marvdasht
City
Marvdasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences Shiraz (International Branch)
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
University of Medical Sciences Shiraz
Full name of responsible person
Hamidreza Bahmani
Position
Anesthesiologist,Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesiology,Shahid Motahhari Hospital, Moallem sq,Marvdasht
City
Marvdasht
Postal code
7187835651
Phone
+98 71 3230 5410
Fax
+98 71 3230 5410
Email
Pencillin2002@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Medical Sciences Shiraz
Full name of responsible person
Hamidreza Bahmani
Position
Anesthesiologist,Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesiology,Shahid Motahhari Hospital,Moallem sq,Marvdasht
City
Marvdasht
Postal code
7187835651
Phone
+98 71 3230 5410
Fax
+98 71 3230 5410
Email
Pencillin2002@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Medical Sciences Shiraz
Full name of responsible person
Hamidreza Bahmani
Position
Anesthesiologist,Assistant Professor
Other areas of specialty/work
Street address
Department of Anesthesiology,Shahid Motahhari Hospital,Moallem sq,Marvdasht
City
Marvdasht
Postal code
7187835651
Phone
+98 71 3230 5410
Fax
+98 71 3230 5410
Email
Pencillin2002@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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