This study is a randomized double-blind clinical trial. The aim of this study is Comparison of infusion of midazolam-ketamine with isofloran-remifentanil on postoperative pain in 96 patients 18-40 years old undergoing rhinoplasty surgery. Patients with a history of liver or kidney problems or sensitivity to drugs will be excluded. Patients are randomly divided into two groups. The patients are not aware of the type of drug which received and Evaluation of patients is performed by anesthesiologist who does not know about the protocol of the study. Anesthesia induction in two groups is with 0.05 mg/Kg midazolam, 3 mcg/Kg fentanyl, 2.5 mg/Kg propofol, 0.5 mg/Kg atracurium. Maintenance of anesthesia in the first group is midazolam-ketamine. Maintenance of anesthesia in the second group is isoflurane-remifentanil. After operative the Severity of pain in patients were assessed with a visual analog scale. If patients needed to analgesic drug they received 10 mg pethidine. The amount of analgesic consumption were recorded at 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030116119N2
Registration date:2014-11-01, 1393/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-01, 1393/08/10
Registrant information
Name
Reza Akhondzadeh
Name of organization / entity
Imam Khomeini Hospital
Country
Iran (Islamic Republic of)
Phone
+98 61 1221 6504
Email address
akhondzadeh-r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jondishapour University of Medical Sciences
Expected recruitment start date
2014-07-01, 1393/04/10
Expected recruitment end date
2015-01-30, 1393/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Of Infusion Of Midazolam-Ketamine With Isofloran-Remifentanil On Postoperative Pain In Patients Undergoing Rhinoplasty Surgery
Public title
The Effect Of Midazolam, Ketamine, Isoflurane And Remifentanil On Postoperative Pain After Rhinoplasty
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: No history of renal, cardiac, hepatic diseases. Exclusion criteria: The control problem of anesthesia during surgery; history of allergy to drugs used during surgery; prolonged surgery; changing the operation to another type of surgery except rhinoplasty
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To randomization: Consecutive odd and even numbers are assigned to patients. midazolam-ketamine and isofloran-remifentanil are administered to odd and even numbered, respectively.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahwaz Jondishapour University Of Medical Sciences
Street address
Office Of Deputy Research & Technology, Ground Floor, Central Library, Golestan BLvd., Ahwaz Jondishapour University of Medical Sciences, Ahwaz
City
Ahwaz
Postal code
Approval date
2014-05-17, 1393/02/27
Ethics committee reference number
ajums.REC.1391.85
Health conditions studied
1
Description of health condition studied
Postoperative Analgesia
ICD-10 code
Y45
ICD-10 code description
complication of medical and surgical care-opioids and related analgesics
Primary outcomes
1
Description
Pain
Timepoint
in the recovery room and 2,4 ,8 ,16 and 24 hours after surgery
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Group1: maintenance of anesthesia with infusion 30-45 mcg/kg/min ketamine and 1.3 mcg/kg/min midazolam and ventilation with 50%
nitrous oxide
Category
Prevention
2
Description
Group2: maintenance of anesthesia with 1 mac isoflurane and ventilation with 50% nitrous oxide and infusion 1-2 mcg/kg/min remifentanil
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Reza Akhondzadeh
Street address
Department of Anesthesiology, General Operating Room, Second Floor Of The Imam Khomeini Hospital, Shahid Ahwazian St., Ahwaz
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz Jondishapour University of Medical Sciences
Full name of responsible person
Nader Saki
Street address
Office of Vice chancellor for research, Ahwaz Jondishapour University of Medical Sciences, Ground Floor, central library, Golestan BLvd., Ahwaz Jondishapour University of Medical Sciences, Ahwaz
City
Ahwaz
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, Ahwaz Jondishapour 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 Khomeini Hospital
Full name of responsible person
Reza Akhondzadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, General Operating Room, Second Floor Of The Imam Khomeini Hospital, Shahid Ahwazian St., Ahwaz
City
Ahwaz
Postal code
Phone
00
Fax
Email
rezaakh@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam khomeini Hospital
Full name of responsible person
Reza Akhondzadeh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Department of Anesthesiology, General Operating Room, Second Floor Of The Imam Khomeini Hospital, shahid Ahwazian st., Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 1221 6504
Fax
Email
rezaakh@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pain Research Center
Full name of responsible person
Sanaz Nazari
Position
Anesthesia Technician
Other areas of specialty/work
Street address
Pain Research Center, Fourth Floor, Imam Khomeini Hospital, Shahid Ahwazian St., Ahwaz
City
Ahwaz
Postal code
Phone
00
Fax
Email
s.nz1990@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)