Protocol summary

Summary
Purpose: In this study we Compare lidocaine gel and methoxyflurane in relieving pain in patients scheduled to undergo elective cystoscopy. Method: After obtaining informed and written consent and permission, 60 patients between the ages of 20 and 55 years undergoing a cystoscopy procedure enrolled in this interventional non-blind clinical study. Exclusion criteria: Allergy to lidocaine and methoxyflurane, concurrent use of analgesics in recent 24 hours, age>55 years old, addiction, renal failure, neuropathy, liver disease, pregnancy. Patient were randomly allocated to two groups, that one of them received methoxyflurane 5 minutes before cystoscop entrance and another was administered lidocaine 2% gel 15 minutes before procedure then were evaluated and compared heart rate, blood pressure, oxygen saturation and pain (utilizing visual analog scale) before entrance, at the time of drug administration, just at the instrument insertion, during bladder examination, end of procedure and 15 minutes after operation. Method of randomization is computer generated. Whenever during study; if patient had pain with score more than 4 based in visual analog scale, should be administered alfentanyl 10 microgram/kg. We compare dose of administered alfentanyl between two groups. After 2 weeks we will measure alanine transaminase, aspartate transaminase, alkaline phosphatase, creatinine, blood urea nitrogen and urine analysis of the patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201207253579N3
Registration date: 2012-12-12, 1391/09/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-12-12, 1391/09/22
Registrant information
Name
Alireza Jafari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2254 9029
Email address
alirezajaffari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-12-15, 1391/09/25
Expected recruitment end date
2013-02-08, 1391/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of lidocaine gel and methoxyflurane in relieving pain in patients scheduled to undergo elective cystoscopy
Public title
Comparison of lidocaine gel and methoxyflurane in cystoscopy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with American Society of Anesthesiologists Physical Status Classification (ASA class) I and II scheduled to undergo elective cystoscopy and their age is between 20-55 years old. Exclusion criteria: Allergy to lidocaine and methoxyflurane, concurrent use of analgesics in recent 24 hours, age>55 years old, addiction, renal failure, neuropathy, liver disease, pregnancy.
Age
From 20 years old to 55 years old
Gender
Male
Phase
2
Groups that have been masked
None
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Urology ethic committee of Shahid Beheshti University of Medical Sciences
Street address
Ninth Boostan Ave., Pasdaran St.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
16

Health conditions studied

1

Description of health condition studied
Analgesic effect of methoxyflurane and lidocaine gel during cystoscopy
ICD-10 code
y.48.0 y.4
ICD-10 code description
Inhaled anesthetics local anesthetics

Primary outcomes

1

Description
pain
Timepoint
Before entrance, at the time of drug administration, just at the instrument insertion, during bladder examination, end of procedure and 15 minutes after operation
Method of measurement
standard visual analog scale

Secondary outcomes

1

Description
Heart rate
Timepoint
Before entrance, at the time of drug administration, just at the instrument insertion, during bladder examination, end of procedure and 15 minutes after operation
Method of measurement
Electrocardiography monitoring

2

Description
Blood pressure
Timepoint
Before entrance, at the time of drug administration, just at the instrument insertion, during bladder examination, end of procedure and 15 minutes after operation
Method of measurement
Noninvasive blood pressure

3

Description
Blood oxygen saturation
Timepoint
Before entrance, at the time of drug administration, just at the instrument insertion, during bladder examination, end of procedure and 15 minutes after operation
Method of measurement
Pulse Oxymetry

Intervention groups

1

Description
Methoxyflurane is a volatile fluorinated hydrocarbon anesthetic agent that is available with 3 CC ampoules to be used in a penthrox inhaler. The inhaler is primed with 3 CC methoxyflurane. The inhaler dispenses 0.2-0.4% with the dilutor hole open and 0.5-0.7% with it closed. The device contains an oxygen port. We used penthrox inhaler for administration of methoxyflurane with activated charcoal scavenging chamber. We asked the patient to close the dilutor hole with his finger and put the inhaler mouth piece in the mouth and exhale through the mouth piece or the nose. For each patient we used maximum one vial (3cc) without oxygen. No more than two patients are to be administered methoxyflurane per shift. Each inhaler is just for one patient.
Category
Prevention

2

Description
Fifteen minutes before the procedure 20 cc lidocaine gel 2% is administered.
Category
Prevention

3

Description
In each step of the study if pain score is more than 4 (utilizing VAS) we will administer 10 microgram/kg alfentanyl.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Labbafi Nejad Hospital
Full name of responsible person
Alireza Jafari
Street address
Ninth Boostan Ave., Pasdaran St.
City
Tehran
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hossein Goudarzi
Street address
Shahid Chamran Highway,Velenjak St., beside Taleghani Hospital, University of Medical Sciences, third floor
City
Tehran
Country
Iran (Islamic Republic of)
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, Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hasti Hassani
Position
MD/ Resident
Other areas of specialty/work
Street address
Ninth Boostan Ave., Pasdaran St.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1666694515
Phone
+98 21 2254 9029
Fax
Email
hasti62h@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Jafari
Position
M.D, Assistant Professor
Other areas of specialty/work
Street address
Ninth Boostan Ave., Pasdaran St.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1666694515
Phone
+98 21 2254 9029
Fax
Email
alirezjaffari@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hasti Hassani
Position
MD/ Resident
Other areas of specialty/work
Street address
Ninth Boostan Ave., Pasdaran St.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
1666694515
Phone
+98 21 2254 9029
Fax
Email
hasti62h@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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