Protocol summary

Study aim
Comparison of the Effectiveness of Nasal fentanyl vs.Intravenous fentanyl in analgesia in patients with cataract surgery
Design
Randomised, superiority, parallel, three-way blind, randomized, on 90 patients.Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site
Settings and conduct
This study was a three-course study conducted at the Feyz Isfahan Medical-Educational Center. The available (easy) sampling method and simple randomization method were used using Random allocation software. The patient surgeon and the person collecting the information were unaware of the patients' drug grouping
Participants/Inclusion and exclusion criteria
Candidates for cataract surgery in adults Criteria for not entering the study: history of allergy or allergic reaction to any of the medications of diet therapy, head injury, high intraocular or intracranial pressure, high-risk cardiovascular disease, hypertension, severe respiratory disease, liver disease, advanced Epilepsy or history of seizures, neurological disorders, tumors or brain metastases, use of any painkillers and anesthesia precursors, chronic pain syndromes, people who are not satisfied with participating in this study
Intervention groups
in Intravenous fentanyl group, (1.5 mg / kg with a volume of 2 cc fentanyl) is prescribed intravenously and 2 cc of distilled water in the nose. In the nasal fentanyl group, 2cc of fentanyl, 1.5 mg / kg intranasaly, and 2 cc of distilled water are administered intravenously.
Main outcome variables
Intravenous fentanyl؛ Intranasal fentanyl

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200605047662N1
Registration date: 2020-06-09, 1399/03/20
Registration timing: retrospective

Last update: 2020-06-09, 1399/03/20
Update count: 0
Registration date
2020-06-09, 1399/03/20
Registrant information
Name
Hamed Norouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3422 2149
Email address
hamednorouzi7337@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-19, 1395/12/29
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2017-03-19, 1395/12/29
Actual recruitment end date
2019-03-19, 1397/12/28
Trial completion date
2019-03-19, 1397/12/28
Scientific title
Comparison of the Effectiveness of Nasal fentanyl vs. Intravenous (IV) fentanyl in anesthesia in patients with cataract surgery
Public title
Effect of Nasal fentanyl in patients with cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
More than 18 years old American Society of Anesthesiologists Classification (ASA) 1 or 2 Candidate for cataract surgery by Phacoemulsification method
Exclusion criteria:
History of any allergic reaction to any of the treatment regimensHistory of head injury, high intraocular or intracranial pressure, high-risk for cardiovascular disease, severe respiratory disease, liver disease, advanced epilepsy or seizure history, neurological disorder, tumor or brain metastasis Use of any anesthetics in last day Chronic pain syndromes
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 90
Actual sample size reached: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The 45 pieces of paper that were written on it A and the other 45 pieces that were written B (a total of 90 pieces) are folded into a non-transparent bag. Then 30 minute before the operation, one of the pieces were selected randomly by a person who does not know about the details. In case of A patient categorized as the intera-venous fentanyl group, and in case of B, it belongs to the nasal fentanyl group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In 30 minute before the surgery, the patient was selected to A and B group by using pieces of paper in a non-transparent bag by person who did not know about the details. The patient didnt know about the grouping. The patient was taken to the operating room and the surgeon and staff of the relevant room did not know about the grouping. After the surgery, the surgeon's satisfaction was recorded by the person who did not know about the grouping. The patient transferred to the recovery room, where was evaluated by the person who had no information about the grouping and the patient's information was recorded. In the operating room, only the person who performed the lottery knew about the grouping, and this person had intravenous and nasal fentanyl in addition to distilled water in the form of nasal and intravenous form, and he was the only person who knew which fentanyl and which distilled water were also. This person was not present in any other part of the patient's information collection and evaluation
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of medical sciences., Azadegan street., Hezar-Jarib blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.MUI.MED.REC.1398.127

Health conditions studied

1

Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Age-related cataract

Primary outcomes

1

Description
Relaxation level during surgery
Timepoint
After surgery, In Recovery room
Method of measurement
Ramsay Sedation Scale questionnaire

2

Description
Satisfaction of the surgeon
Timepoint
After surgery
Method of measurement
Visual Analogue Scale questionnaire

3

Description
Satisfaction of the patient
Timepoint
After surgery
Method of measurement
Visual Analogue Scale questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Patients after grouping, if they were in the nasal fentanyl group, were given a single dose of intranasal fentanyl (1 mg / kg with a volume of 2 cc),10 minutes before the surgery and at the beginning of surgery, Distilled water (2 cc) were prescribed Intravenously
Category
Treatment - Drugs

2

Description
Intervention group 2: Patients after grouping, if they were in the intera-venous fentanyl group, were given a single dose of intranasal Distilled water (2 cc) ,10 minutes before the surgery and at the beginning of surgery, fentanyl (1 mg / kg with a volume of 2 cc) were prescribed Intravenously
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
Hamed Norozi
Street address
Hezar-Jarib street., Universiy of medical sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
hamednorouzi7337@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Street address
Hezar-Jarib Street., Universiy of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
Hamednorouzi7337@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamed Norouzi
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Hezar-Jarib street., University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7654
Email
Hamednorouzi7337@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamed Norozi
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Hezar-Jarib., University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7654
Email
Hamednorouzi7337@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamed Norozi
Position
Medical Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Hezar-Jarib., University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7654
Email
hamednorouzi7337@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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