Protocol summary

Study aim
Comparison and Determination of the sedative Effect of Fentanyl-dexmedetomidine Combination with Fentanyl-Midazolam during Phacoamulsification
Design
Double blinded clinical trial randomized by Randome Allocation and simple random sampling parallel group design of 70 patients enrolled by inclusion and exclusion criteria in this study.
Settings and conduct
The use of two different drugs with specific doses in two groups and comparing their effect on the sedation level in cataract surgery by phacoamulsification in Feyz Hospital in Isfahan. The patient and Researcher unaware of which drugs are used for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients aged 18–85 years old ASA class 1 & 2 scheduled for phacoemulsification cataract surgery and exclusion criteria is refusing, mentally challenged patients , history of chronic use of sedatives, narcotics or alcohol , allergy to any of the study medications , patients with severe chronic obstructive pulmonary disease, Asthma,, history of cardiac disease (cardiac block and bradycardia) bradycardia (heart rate less than 50 beats per minute), systolic blood pressure less than 90 mm, Severe hepatic failure, uncontrolled diabetes, left ventricular failure (EF less than 30), and cerebrovascular disease,severe renal failures
Intervention groups
The Intervention group is patient who candidated for phacoamulsification with Fentanyl-dexmedetomidine Combination and Control group is Patient who candidated for Phacoamulsification with Fentayl-Midazolam combination
Main outcome variables
Sedation level;

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180416039326N3
Registration date: 2018-10-15, 1397/07/23
Registration timing: retrospective

Last update: 2018-10-15, 1397/07/23
Update count: 0
Registration date
2018-10-15, 1397/07/23
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hamidshetabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-11, 1397/03/21
Expected recruitment end date
2018-07-12, 1397/04/21
Actual recruitment start date
2017-06-11, 1396/03/21
Actual recruitment end date
2018-07-12, 1397/04/21
Trial completion date
2018-07-23, 1397/05/01
Scientific title
Comparison of the sedative effect with Dexmedetomidine-Midazolam and Fentanyl- Midazolam in patients who candidated for Phacoemulsification cataract surgery referred to Isfahan Feyz hospital from 2017-2018
Public title
A comparison of sedative effect with dexmedetomidine -fentanyl versus midazolaml–fentanyl during cataract surgery with phacoemulsification technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 18–85 years old ASA class 1 & 2 scheduled for phacoemulsification cataract surgery
Exclusion criteria:
refusing, mentally challenged patients , history of chronic use of sedatives, narcotics or alcohol , allergy to any of the study medications , patients with severe chronic obstructive pulmonary disease, Asthma,, history of cardiac disease (cardiac block and bradycardia) bradycardia (heart rate less than 50 beats per minute), systolic blood pressure less than 90 mm, Severe hepatic failure, uncontrolled diabetes, left ventricular failure (EF less than 30), and cerebrovascular disease,severe renal failures
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 70
Actual sample size reached: 63
Randomization (investigator's opinion)
Randomized
Randomization description
The division of patients into two groups is based on a simple random sampling and Random allocation
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blinded.Patient and researcher are unaware of patient groups and type of medication.The medications are prepared by an anesthetist and encoded an then injected.Demographic information; Sedation level. The quality of pain relief and hemodynamic variables and complications are collected by a patient who is not aware of the type of drug and patient grouping.
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, Hezar Jarib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-10-02, 1397/07/10
Ethics committee reference number
IR.MUI.MED.REC.1397.051

Health conditions studied

1

Description of health condition studied
Cataract surgery
ICD-10 code
H28
ICD-10 code description
Cataract in diseases classified elsewhere

Primary outcomes

1

Description
Sedation level
Timepoint
Every 5 minutes during surgery
Method of measurement
Ramsay sedation score

Secondary outcomes

1

Description
Medium atrial Blood pressure
Timepoint
Immediately before surgery, every 5 minutes during surgery and every 10 minutes for 30 minutes in recovery
Method of measurement
Pressure gauge

2

Description
Oxygen saturation percentage
Timepoint
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Pulse oximetry

3

Description
Heart rate
Timepoint
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Pulse oximetry

4

Description
Surgeon satisfaction
Timepoint
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Likert questionnaire

5

Description
Patient satisfaction
Timepoint
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Likert questionnaire

6

Description
adverse drug reactions
Timepoint
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Adverse drug reaction questionnaire

7

Description
Pain intensity
Timepoint
Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery
Method of measurement
Universal Pain assessment tool

8

Description
Recovery time
Timepoint
After completing the intervention until the withdrawal from the recovery
Method of measurement
Minutes

Intervention groups

1

Description
Intervention group:patient in group (FD) received 1μg/kg Fentanyl with 0/5 μg/kg Dexmedetomidine in 20cc Normal salin for 10 minutes and then the continuous infusion of Dexmedetomidine 0/5 μg/kg/hr until the end of surgery.
Category
Treatment - Drugs

2

Description
Control group:patient in group (FM) received 1μg/kg Fentanyl with 0/05 mg/kg Midazolam in 20cc Normal salin for 10 minutes and then the continuous infusion of Midazolam 0/05 mg/kg/hr until the end of surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Feyz Hospital , Modares St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۶۴
Phone
+98 31 3445 2035
Email
Hamidshetabi@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh haghjooy javanmard
Street address
Vice chancellor of research and technology of university, Isfahan University of Medical Sciences, Hezarjarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Sh_haghjoo@med.mui.ac.ir
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
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
Hamidshetabi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۶۴
Phone
+98 31 3668 5555
Email
Hamidshetabi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz hospital, Modares St
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۶۴
Phone
+98 31 3668 8138
Email
hamidshetabi@med.mui.ac.ir

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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