Comparison of inhalational Isoflurane-Nitrous oxide anesthesia and intravenous Propofol-Remifentanil anesthesia on postoperative pain in open reduction and internal fixation of leg and ankle.
Comparison of pain scale after the open fracture of leg and ankele between intravenus and inhalation anesthesia
Design
Double blind randomized controlled clinical trial with two parallel arms group.
Settings and conduct
The research will be performed as a double-blind clinical trial.The investigator and the analyst are not aware of the type of intervention ,The sample will consist of 60 patients in the operating room of Shahrud Imam Hossein Hospital .The patients were randomly assigned according to quadruple blocks in two groups (group A or intervention) or (group B or control)
In both groups, the patients were kept fast at least 8 hours,And through a safe intravenous line, a pre-anesthetic drug (fentanyl, one microgram per kilogram of weight) will be prescribed.Initiation of anesthesia is performed by injection of Propofol 2mg / kg and muscle relaxation with atracurium 0.5 mg / kg and intracranial intubation. In the intervention group, the anesthetic continues to be as follows
Remifentanil 0.25 μg / kg / min + Propofol 150 μg / kg / min equivalent to 60 ml propofol 1% per hour and 20 ml remifentanil per hour (50 μg / ml concentration). A patient with 50% oxygen will be ventilated
In the control group, anesthesia with nitrous oxide with oxygen (50% N2O / 50% O2) and isoflurane (1.2% - 1.5%) would be continued in both The study is conducted at Imam Hossein Shahroud Hospital
Participants/Inclusion and exclusion criteria
Arrival:
Female or Male
Age between 18 until 60
ASA class 1,2
Patients with open fractures of leg & ankle
Exclusion:
Drug abuse & opiate,
History of anticonvulsions or antidepressent therapy,
Anesthesia or surgery complications
Comparison of inhalational Isoflurane-Nitrous oxide anesthesia and intravenous Propofol-Remifentanil anesthesia on postoperative pain in open reduction and internal fixation of leg and ankle.
Public title
The effect of nitrous oxide inhaled isoferons on postoperative pain "The effect of Remifentanil propofol on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female
Age between 18 until 40
ASA class 1,2
Patients with open fractures of leg & ankle
Exclusion criteria:
A history of drug use and drug abuse
Anticonvulsant intake, sedative, anti-depressant
Any complications that change the procedure and anesthesia
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
According to randomized quadruple blocks,researcher gives a predetermined series of 60 A and B cards to the anesthetist and based on this pattern participants will assign in to either intervention (A) or control (B) group. After the examination of the patient, After examination of the patient, anesthetist gives information about this study to every participant that has inclusion criteria,, removes an envelope in the order specified (blind concealment) and based on the envelope, group A and B is determined. Researcher and analyst before the end of the study are not aware of the type of intervention in the two groups A and B and and only the type of the group is recorded in the questionnaire.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is unaware of his grouping. The analysis and analysis of the consequences are done by unknown scholars of grouping. The questionnaire consists of two parts, each containing both parts of a single code.
After the anesthetic, the section containing the patient's demographic information is separated and the patient will record the outcome of the postoperative pain in the second part.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahrud university of medical sciences
Street address
Shahrud university of medical sience, Haftetir Squard
City
Shahrud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2016-11-09, 1395/08/19
Ethics committee reference number
IR.SHMU.REC.1395.122
Health conditions studied
1
Description of health condition studied
Postoperative pain intensity in candidal patients for open leg and ankle surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score with NRS questionnaire
Timepoint
2,4,6 hours after transfer of the ward then every 6 hours within 24 hours
Method of measurement
NRS questionnaire
Secondary outcomes
1
Description
Dose of pethidine prescribed
Timepoint
2,4,6 hours after transfer to ward then every 6 hours within 24 hours
Method of measurement
NRS questionnaire
Intervention groups
1
Description
In both groups, the patients are kept at least 8 hours fasting and prescribed by a safe line prior to anesthesia (fentanyl, one microgram per kilogram of weight). Anesthesia starts with Propofol injection of 2mg / kg and muscle relaxation with 0.5 mg / kg atracurium injections. Then, anesthesia is performed in the intervention group: Remifentanil 0.25 μg / kg / min + Propofol 150 μg / kg / min, which is equivalent to 60 ml propofol 1% per hour and 20 ml remifentanil per hour (concentration 50 μg / ml). The patient will be ventilated with 50% oxygen. In the control group, anesthesia with nitrous oxide with oxygen (50% O2 / 50% N2O) and isoflurane (1.5%-1.2%) will continue to be carried out in both groups of cardiovascular and respiratory monitoring And the depth of anesthesia will be adjusted according to the clinical symptoms. Muscle promoter can be repeated in both groups. In recovery, pethidine pain will be given at a dose of 20 mg. After transfer to the unit, if pethidine is present, it will be prescribed 20 mg every 6 hours.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Niloofar Khoobestani
Street address
Imam Hossein hospital,Operating room, End of Ayatollah Towhidi avenue
City
Shahrud
Province
Semnan
Postal code
36169-11151
Phone
+98 21 4422 0262
Email
niloofar.kh71@yahoo.com
Web page address
http://eh.shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammmad Hasan Emamian
Street address
Deputy of research;Shahrud university of medical sciences,7th of TIr Square
City
Shahrud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Fax
Email
emamian@shmu.ac.ir
Web page address
http://shmu.ac.ir/research/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?