Protocol summary

Summary
In the recent years, physicians and health care centers focused on effectiveness and cost of medical procedures. This single blind clinical trial is designed to compare and evaluate the costs and benefits of two anesthetic methods, fentanyl/ propofol anesthesia versus fentanyl/isoflurane anesthesia. Among surgical patients in Shahroud’s Imam Hossein hospital, 100 consecutive adult man or woman with 18 to 60 years old will be selected and informed about the study. Inclusion criteria are: an anesthesia risk of 1 or 2 (According to American society of anesthesiologist's classification); orthopedic or reconstructive operations on extremities; hip and pelvic operations; Inguinal hernioraphy; abdominal hernioraphy; cholecystectomy; appendectomy. Patients with a history of opiates or alcohol abuse, sedative and anticonvulsive therapy, anesthesia or surgical complications will be excluded from the study. Measurable outcomes during procedures are BIS index, systolic blood pressure, pulse rate, sweating, pupil’s size and light reflex. Postoperative pain, agitation, nausea and vomiting and also, Modified Alderet scoring system (MASS) will be assessed in post anesthesia care unit. Finally, we will calculate anesthesia cost in each participant Measurable outcomes during procedures are BIS index, systolic blood pressure, pulse rate, sweating, pupil’s size and light reflex. Postoperative pain, agitation, nausea and vomiting and also, Modified Alderet scoring system (MASS) will be assessed in post anesthesia care unit. Finally, we will calculate anesthesia cost in each participant.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013022712123N2
Registration date: 2013-09-07, 1392/06/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-09-07, 1392/06/16
Registrant information
Name
Javad Nourian
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 27 3334 2001
Email address
javadnourian@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Shahroud University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative cost-effectiveness analysis of intravenous propofol anesthesia and inhalational isoflurane anesthesia in patients undergo open surgery with bispectral monitoring at Shahroud’s Imam Hossein hospital
Public title
Cost-effectiveness analysis of intravenous propofol anesthesia versus inhalational Isoflurane anesthesia in patients undergo open surgery at Shahroud's Imam Hossein hospital.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Man or woman with 18 to 50 years old;an anesthesia risk of 1 or 2 (According to American society of anesthesiologist's classification); orthopedic or reconstructive operations on extremities; hip and pelvic operations;Inguinal hernioraphy; abdominal hernioraphy; cholecystectomy; appendectomy. Exclusion criteria: Patients with a history of opiates or alcohol abuse; sedative and anticonvulsive therapy; anesthesia or surgical complications during operation
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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, Deputy of research, Shahroud University of Medical Sciences
Street address
Ethics committee, Deputy of research, Shahroud University of Medical Sciences, 7th of Tir square, Shahroud, Iran. Postal code: 3614773955
City
Shahroud
Postal code
3614773955
Approval date
2013-01-09, 1391/10/20
Ethics committee reference number
9112

Health conditions studied

1

Description of health condition studied
Calculus of gallbladder with acute cholecystitis
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis

2

Description of health condition studied
Anesthesia for appendectomy
ICD-10 code
K35
ICD-10 code description
Acute appendicitis

3

Description of health condition studied
Ventral hernia without obstruction or gangrene
ICD-10 code
K43.9
ICD-10 code description
Ventral hernia

4

Description of health condition studied
Unilateral or unspecified inguinal hernia, without obstruction or gangrene
ICD-10 code
K40.9
ICD-10 code description
Unilateral or unspecified inguinal hernia, without obstruction or gangrene

5

Description of health condition studied
Abnormal uterine and vaginal bleeding, unspecified
ICD-10 code
N93.9
ICD-10 code description
Abnormal uterine and vaginal bleeding, unspecified

6

Description of health condition studied
Fracture of neck of femur
ICD-10 code
S72
ICD-10 code description
Fracture of femur

7

Description of health condition studied
Fracture of lower leg, including ankle
ICD-10 code
S82
ICD-10 code description
Fracture of lower leg, including ankle

8

Description of health condition studied
Fracture of upper limb, level unspecified
ICD-10 code
T10
ICD-10 code description
Fracture of upper limb, level unspecified

Primary outcomes

1

Description
BIS (Depth of anesthesia)
Timepoint
Every 5 minutes during operation
Method of measurement
By using Danmeter’s Cerebral State Monitor (Model CSM2) and record BIS index as an exact number from 0 to 100 every 5 minutes

2

Description
Heart rate
Timepoint
before procedure and every 5 minutes during operation
Method of measurement
Novin saadat's cardiac monitoring and record as beat per minute

3

Description
Systolic blood pressure
Timepoint
before procedure and every 5 minutes during operation
Method of measurement
Novin saadat's automatic Non invasive BP monitoring and record as mmHg

4

Description
Pupil's reflex
Timepoint
Every 5 minutes during operation
Method of measurement
Clinical observation and chart as Yes or No

5

Description
Pupil's size
Timepoint
every 5 minutes during procedure
Method of measurement
Clinical observation and chart as an exact number from 1 to 10 (milimeter)

6

Description
Sweating
Timepoint
Every 5 minutes during operation
Method of measurement
Clinical observation and chart as Yes or No

Secondary outcomes

1

Description
Postoperative agitation
Timepoint
Every 5 minutes during recovery
Method of measurement
Clinical observation and chart as Yes or No

2

Description
Postoperative nausea and vomiting
Timepoint
Every 5 minutes during recovery
Method of measurement
Clinical observation and chart as Yes or No

3

Description
Recovery time
Timepoint
Every 5 minutes during recovery
Method of measurement
The end of recovery will be determined by Modified Alderet scoring system (MASS). In this system, scoring 9 points in 5 variables of consciousness, circulation (systemic blood pressure), breathing, SPO2, and activity, each of 2 points, specifies the end of recovery

4

Description
Postoperative pain
Timepoint
Every 5 minutes during recovery
Method of measurement
Clinical observation and chart as Yes or No

5

Description
Anesthesia cost
Timepoint
Time of discharge
Method of measurement
Total drug's (Isoflurane or Propofol) cost in Rial

Intervention groups

1

Description
In control group, premedication will be Fentanyl (1 µg/kg) and midazolam 0.05 mg/kg. Induction of anesthesia is intravenous propofol with dose of 1.5 mg/kg Maintenance of anesthesia will be performed with a consentration of 2% isoflurane (1.7 MAC) in combination with equal amount of N2O / O2 , Every 5 minutes isoflurane consentration will be adjusted according to depth of anesthesia.
Category
Treatment - Drugs

2

Description
In intervention group premedication is Fentanyl (1 µg/kg) and midazolam 0.05 mg/kg. Induction of anesthesia is intravenous propofol with dose of 1.5 mg/kg Maintenance of anesthesia intravenous propofol will be started at a rate of 140 µg/kg/hours in combination with equal amount of N2O / O2 , Every 5 minutes propofol infusion rate will be adjusted according to depth of anesthesia.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Operation room, Imam Hossein hospital
Full name of responsible person
Javad Nourian MD
Street address
End of Ayatollah Towhidi avenue,Imam Hossein hospital, Shahroud, Iran
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research, Shahroud University of Medical Sciences
Full name of responsible person
Ahmad Khosravi
Street address
Deputy of research, Shahroud University of Medical Sciences, 7th of Tir square
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research, Shahroud 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
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Imam Hossein Hospital, operation room, End of Towhidi avenue
City
Shahroud
Postal code
3616911151
Phone
+98 27 3334 2001
Fax
+98 27 3333 3902
Email
javadnourian@shmu.ac.ir
Web page address
http://eh.shmu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Imam Hossein Hospital, operation room, End of Ayatollah Towhidi avenue
City
Shahroud
Postal code
3616911151
Phone
+98 27 3334 2001
Fax
+98 27 3333 3902
Email
javadnourian@shmu.ac.ir
Web page address
http://eh.shmu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran
Full name of responsible person
Javad Nourian MD
Position
Assistant professor of anesthesiology, department of anesthesia and intensive care
Other areas of specialty/work
Street address
Imam Hossein Hospital, operation room, End of Ayatollah Towhidi avenue
City
Shahroud
Postal code
3616911151
Phone
+98 27 3334 2001
Fax
+98 27 3333 3902
Email
javadnourian@shmu.ac.ir
Web page address
http://eh.shmu.ac.ir/

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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