Trial is done in Sina hospital, Tehran, Iran. It is a double blind randomized controlled trial using block randomization method as sampling. A single dose of 75 mg of Pregabalin or Placebo intaked by cases or control group two hours before anesthesia induction.We use remifentanil plus isoflurane/propofol in maintenance of anesthesia.Post operative pain is scored by participants during 2 hours of care in post anesthesia care unit by means of Visual Analogue Scale. Also dose of fentanyl as analgesic used in PACU is recorded for every participants according to his/her need. postoperative Pain, Nausea, Vomiting, double vision as side effect and sedation score are evaluated regularly during 24 hours of postoperative period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017043033706N1
Registration date:2017-05-22, 1396/03/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-22, 1396/03/01
Registrant information
Name
Ali Jalali
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 0000
Email address
a.jalali.md@gmail.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a single dose of Pregabalin before induction of anesthesia on postoperative pain score of septo-rhinoplasty cases ,A double blind RCT
Public title
Effect of pregabalin on post operative pain of septorhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
INCLUSION CRITERIA:
Age 18-55 years old
ASA Class I-II
Candidate for elective Septorhinoplasty, Septoplasty or Rhinoplasty
Sign informed consent
EXCLUSION CRITERIA:
Patients with a history of drug or Alcohol abuse
Impaired kidney or liver function
Antidiabetic, antidepressant, antiepileptic, antihypertension medication
Pregnant or breast feeding patients
History of hypersensitivity to any of the drugs used in the study
Peptic ulcer, NSAID related dyspepsia
History of daily intake of analgesics or intake of any analgesics within 24 hours before septoplasty
and inability to cooperate
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
committee of ethics in medical research, Tehran University of Medical Sciences
Street address
Pour Sina street.Tehran University of Medical Sciences.
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1622
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain Unspecified
Primary outcomes
1
Description
Postoperative Pain Score
Timepoint
We Measure Pain at 10 minute pos-extubation, 30 min post-extubation, 60 min post-extubation, 2 hours post-extubation, 6 hours post-extubation and 24 hrs post-extubation.
Method of measurement
Visual Analouge Scale of Pain (VAS)
2
Description
Total fentanyl injected postoperativly
Timepoint
120 minutes post operative
Method of measurement
Based on PACU documents in microgram
3
Description
Total Ibuprofen recived
Timepoint
24 hours post-extubation
Method of measurement
Miligram units based on participants file and answer
Secondary outcomes
1
Description
Extubation time
Timepoint
the time between cessation of all anesthetics and extubation
Method of measurement
Based on minutes, measured by a clock
2
Description
Total remifentanil used during anesthesia
Timepoint
At the time of Extubation
Method of measurement
Measured based on microgram/kg/min
3
Description
Postoperative Agitation
Timepoint
Measured in PACU
Method of measurement
Based on Ramsay Sedation Scale
4
Description
Postخperative Nausea and Vomiting
Timepoint
During 120 min PACU care; 24 hrs after Extubation
Method of measurement
Obsevation in PACU, Answer of patint after 24 hrs
5
Description
Double vision
Timepoint
During 120 min PACU care; 24 hrs after Extubation
Method of measurement
Answer of patient
Intervention groups
1
Description
A capsule of 75 mg Pregabalin (Lyrica) administered two hours before induction of anesthesia in intervention group
Category
Treatment - Drugs
2
Description
A placebo capsule administered two hrs before induction of anesthesia in control
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital, Tehran University of Medical Sciences
Full name of responsible person
Ali Jalali
Street address
Sina Hospital, 30 Tir street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Street address
Poursina street, Tehran university of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ali Jalali
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital, 30 Tir street
City
Tehran
Postal code
Phone
+98 21 6312 0214
Fax
Email
a.jalali.md@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamadreza khajavi
Position
Professor of Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital, 30 Tir
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
khajavim@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Jalali
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Sina Hospital, 30 Tir street
City
Tehran
Postal code
Phone
+98 21 6312 0000
Fax
Email
a.jalali.md@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)