The present study aims to compare the sedation effects of Sufentanil and midazolam with nitrous oxide during cataract surgery. It is a double blind clinical study. 100 patients attending Imam Khomainy hospital in Kermanshah were candidate to have cataract surgery who were divided to control and experiment group randomly. The experiment group received a mixture of %33 nitrous oxide and %66 oxygen in Face ratio with flow of 6 lit/min. Extra gas and patient’s expiration were vacuumed using a mask which was linked to the air conditioning system. After 3 to 5 minutes after gas emission, members of the control group were under surgery using regional anesthesia perry bulbar. 5 Milligram of sufentanil (common treatment) was indoctrinated with oxygen and air in ratio of %50 in a flow of 6 liters in minute in %50 and patients were operated using regional anesthesia perry bulbar and infusion face mask 100 to 500 milliliter liquid. Both groups were examined for their blood pressure heart rate, vein blood oxygen saturation before the surgery, beginning the surgery and throughout the surgery every 5 minutes. They were also checked before transferring the patient to recovery room.
Inclusion: satisfaction of patients; candidates to cataract surgery;
Exclusion: people under 18 or over 80; pregnant women; patients with chronic lung diseases; heart failure with chronic hypoxemia; addicts; patients who experienced general anesthesia or surgeries longer than 30 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015011314333N28
Registration date:2015-01-31, 1393/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-31, 1393/11/11
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah university of medical sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparation of sedation sufentanil and midazolam with nitrous oxide in patients of cataract surgery
Public title
Comparison of sedation effects of sufentanil and midazolam with nitrous oxide in cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: satisfaction of patients; candidates to cataract surgery;
Exclusion: people under 18 or over 80; pregnant women; patients with chronic lung diseases; heart failure with chronic hypoxemia; addicts; patients who experienced general anesthesia or surgeries longer than 30 minutes.
Age
From 18 years old to 80 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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2014-03-04, 1392/12/13
Ethics committee reference number
420/7/پ/3959
Health conditions studied
1
Description of health condition studied
cataract surgery
ICD-10 code
H43.9
ICD-10 code description
Disorder of vitreous body, unspecified
Primary outcomes
1
Description
Blood pressure
Timepoint
Every 5 minutes before the surgery, beginning the surgery and during the surgery; after the surgery and before transferring the patient to recovery room
Method of measurement
Recording blood pressure with monitoring tools
2
Description
Heart beat
Timepoint
Every 5 minutes before the surgery, beginning the surgery and during the surgery; after the surgery and before transferring the patient to recovery room
Method of measurement
The number of heart beats recorded by monitoring tool
3
Description
Vain blood oxygen saturation
Timepoint
Every 5 minutes before the surgery, beginning the surgery and during the surgery; after the surgery and before transferring the patient to recovery room
Method of measurement
Based on ratio of vein blood oxygen saturation recorded by monitoring and pulse oximetry tools
4
Description
Patient movement
Timepoint
Beginning the surgery and every 5 minutes to the end of the surgery
Method of measurement
By the doctor
Secondary outcomes
empty
Intervention groups
1
Description
The experiment group received a mixture of nitrous oxide (aspiration gas with oxygen made in Iran Darman Gaz) and oxygen company with ratio of %66 and %33 in Face mask with flow of 6 lit/min while it is fixed on the patient’s face. Extra gas and patient’s expiration were vacuumed through the mask which was linked to the air conditioning system. After 3 to 5 minutes after gas emission, operation is accomplished using regional anesthesia perry bulbar. Patients were examined for their blood pressure heart rate, vein blood oxygen saturation before the surgery, beginning the surgery and throughout the surgery every 5 minutes. They were also checked before transferring the patient to recovery room.
Category
Treatment - Drugs
2
Description
The experiment group received 5 Milligram of sufentanil (common treatment) (the injection of mic/ml made of Teharan Daroopakhsh company-Iran) and 1 milligram of IV midazolam 5 mg/ml (produced by Teharn daroopakhsh company-Iran) were indoctrinated with oxygen and air in ratio of %50 in a flow of 6 liters in minute in %50. Face with 100 to 500 milliliter liquid was used and patients went under operation using regional anesthesia perry bulbar. Then, patients were examined for their blood pressure heart rate, vein blood oxygen saturation before the surgery, beginning the surgery and throughout the surgery every 5 minutes. They were also checked before transferring the patient to recovery room.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeyni hospital
Full name of responsible person
Dr. Ali Gholami
Street address
Emam Khomeyni hospital, Street of Naghliyeh
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Bahman Roshani
Position
Anesthesiologists
Other areas of specialty/work
Street address
Emam Khomeyni hospital, Street of Naghliyeh
City
Kermanshah
Postal code
Phone
+98 83 3728 5054
Fax
Email
Broshani@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)