Protocol summary

Study aim
Evaluation of the effect of premedication with sufentanil and intramedullary doxamethomidine on reducing the incidence of myoclonus and pain due to induction of general anesthesia with otitis media and its comparison with control group
Design
A clinical trial with 3 groups, three randomized blinds is performed on 108 patients.
Settings and conduct
This study is a double-blind randomized clinical trial with a control group that is conducted in Al-Zahra Educational and Medical Center affiliated to Isfahan University of Medical Sciences in 2018-2019. The target population of the study will be candidates for surgeries admitted to the hospital
Participants/Inclusion and exclusion criteria
۵۲۹/۵۰۰۰ Inclusion and exclusion criteria: A- Entry criteria: 1- Patients 18 to 60 years old 2- ASA class 1 and 2 3- Candidate for surgery and needs general anesthesia 4 - Lack of heart and liver failure, mental illness, neurological diseases, allergies to opioids 5- Not receiving painkillers and sedatives during the last 24 hours 6- Agreeing to participate in the study B- Criteria for not entering: 1. Age less than 18 years or more than 65 years 2. Drug addiction C- Criteria for leaving the study: 1- Lack of cooperation of the person to answer the questions 2- Occurrence of drug allergies 3- 3-change in anesthesia method
Intervention groups
The first group was injected with 0.1 micrograms per kilogram intravenously and the second group was injected with 0.5 mg / kg dexmedetomidine intravenously Special is done.
Main outcome variables
Medium arterial pressure Myoclonus recovery the pain Spo2

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101211005362N25
Registration date: 2020-07-30, 1399/05/09
Registration timing: retrospective

Last update: 2020-07-30, 1399/05/09
Update count: 0
Registration date
2020-07-30, 1399/05/09
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-21, 1397/04/30
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of sufentanil and dexmedetomidin on myoclonus incidence and pain induced by anesthesia with etomidate: a double blin clinical trial study
Public title
Comparative effect of sufentanil and dexmedetomidin on myoclonus incidence and pain induced by anesthesia with etomidate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 60 years ASA Class 1 and 2 Candidate for surgery and in need of general anesthesia Agree to participate in the study
Exclusion criteria:
heart and liver failure, mental illness, neurological diseases, opioid allergy Drug addiction
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible additions were assigned to the three study groups using randomized block methods with a size of 6 blocks and using random allocation software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In the present study, the injector and the data collector also had no information and the participants did not know the type of drug received. The injector has no knowledge of the type of drug (blinding) and the data collector has no knowledge of the type of drug (both sides of the blind). Premedication drugs are coated in 10 ml syringes with prior coding. After administering 100% oxygen, premedication is given intravenously over a period of 2 minutes. The second anesthesiologist, who is not aware of grouping, then records the myoclonus movements and pain of the patients based on scoring. The first anesthesiologist injects only medications and collects information such as pain and myoclonus, mean arterial pressure, heart rate, blood oxygen saturation percentage at the general time 0, 5, 10, 15, 30, and 60 minutes after atomiditis. They do not have any information about the type of medicine they received.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan-University of Medical Sciences, School of Medicine
City
Isfahan
Province
Isfehan
Postal code
6215489654
Approval date
2020-05-08, 1399/02/19
Ethics committee reference number
IR.MUI.MED.REC.1399.126

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
Y48.2
ICD-10 code description
premedication anesthetic

Primary outcomes

1

Description
Myoclonus
Timepoint
Minutes 0 - 5 - 10 - 15 - 30 - 60 - 60 after atomiditis injection
Method of measurement
Pulse oximeter

Secondary outcomes

empty

Intervention groups

1

Description
In the present study, there are two intervention groups and one control group. 1- In the first intervention group, sufentanil is injected intravenously at the rate of 0.1 micrograms per kilogram
Category
Treatment - Drugs

2

Description
Intervention group: 2- In the second intervention group, dexmedetomidine is injected intravenously at the rate of 0.5 micrograms per kilogram.
Category
Treatment - Drugs

3

Description
Control group: 3- In the control group, distilled water is injected in the amount of 5 cc.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Mohammad Reza Safavi
Street address
Isfahan-Alzahra Hospital, University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
6215421235
Phone
+98 31 3668 5555
Email
safavi@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyyed Hossein Mirhendi
Street address
medical School- Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
6215425654
Phone
+98 31 3668 5555
Email
safavi@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
Mohammadreza Safavi
Position
Professor of anesthesia
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
City
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Province
Isfehan
Postal code
6215423542
Phone
+98 31 1273 2659
Fax
+98 31 1273 2659
Email
safavi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Safavi
Position
Associate Professor of Anesthesia
Latest degree
Specialist
Other areas of specialty/work
Street address
Anesthesiology and Critical Care Research Center,Isfahan University of Medical Sciences, Isfahan, Iran
City
isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1625 5555
Fax
+98 31 1273 2659
Email
safavi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zohreh Niknejad
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Faculty of Medicine - Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
6215432654
Phone
+98 913 366 0030
Email
Rrosa956@yahoo.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
Not applicable
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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