1. Home
  2. Approved trials
  3. » فارسی

Comparison of sedative effect of dexmedetomidine and midazolam in patients undergoing EUS procedure outside the operating room

Protocol summary

Study aim
Comparison effect of dexmedetomidine with midazolam in patients undergoing endosonographic procedure on anxiety and pain
Design
126 Patients were randomly divided into 1st intervention group as test group and 2nd intervention group as control group. according to odd or even patient profile number randomization will be done and till end of analysis, statistician will be blinded. sample size were estimated 57 in each group and 10% Loss percentage 63 patient were allocate in each group. this clinical trial will be done in second phase of clinical trial
Settings and conduct
Patient undergoing Endosonigraphy of Imam Khomeini Hospital, after filling consent form enter to study. patient randomly divided into two groups of 63 number.In anesthetic procedure Heart rate, MAPM SpO2 was recorded. after anesthetist procedure analgesia with Ambesh score, sedation with RSS and post operative nausea and vomiting with VAS was recoded
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patients undergoing GI endosonography Exclusion criteria: allergies to the drugs, age <18 or >65 years old, renal or hepatic failure, chronic pain syndromes, unwillingness to participate in the study, cardiovascular disease, respiratory, metabolic, and neurological disorders, difficulties in the airway, class ASA III or IV contraindication of dexmedetomidine, midazolam, propofol, or fentanyl.
Intervention groups
1st intervention group: Received dexmedetomidine 1 ug/kg during 10 minutes with propofol 0.5 mg/kg and fentanyl 1 mg/kg 2nd intervention group: midazolam group received midazolam 0.03 mg/kg with propofol 0.5 mg/kg and fentanyl 1 mg/kg
Main outcome variables
Heart rate (HR), mean arterial pressure (MAP), and oxygen saturation (SpO2), Ramsay Sedation Scale (RSS) Nausea and vomiting were assessed using Visual Analogue Scale (VAS), analgesia with Ambesh score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190417043295N1
Registration date: 2020-02-21, 1398/12/02
Registration timing: retrospective

Last update: 2020-02-21, 1398/12/02
Update count: 0
Registration date
2020-02-21, 1398/12/02
Registrant information
Name
Reza Baghbanian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 0168
Email address
baghbanian-r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
2019-04-21, 1398/02/01
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-11-22, 1398/09/01
Scientific title
Comparison of sedative effect of dexmedetomidine and midazolam in patients undergoing EUS procedure outside the operating room
Public title
Comparison sedative effect of Dexmedetomidin & midazolam
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for gastrointestinal endosonography Declaration of consent for entry into the study and signature of the consent form Anesthesia ASA class I and II Age range 18 to 65 years
Exclusion criteria:
Renal Failure Liver Failure Sensitivity to the drugs studied Drug addiction Chronic pain syndromes Cardiovascular disease Respiratory disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 126
Actual sample size reached: 130
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to two groups of dexmedetomidine and midazolam (by using even and odd numbers) and based on the case number.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the injection, the information is recorded in Groups A and B, and until the end of the analyzer's analysis, which group of medication allocation information is inappropriate. Patients are unaware of the type of medication given the injection of the drug in the anesthetic process.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz jundishapur University of Medical Science
Street address
bahman street-Golestan Ave.,Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.AJUMS.REC.1398.002

Health conditions studied

1

Description of health condition studied
patients undergoing gastrointestinal Endosonography outside the operating room
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia

2

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
rate of Sedation (RAMSAY index)
Timepoint
during endo-sonography procedure
Method of measurement
Ramsay Sedation Scale

2

Description
Pain
Timepoint
Before, during and 1 hour after procedure
Method of measurement
Ambesh Pain score

3

Description
Nausea and vomiting
Timepoint
Before, during and 1 hour after procedure
Method of measurement
(VAS) Visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dexmedetomidine 1 ug/kg inf. for 10 min, propofol 0.5 mg/kg and fentanyl bolous
Category
Treatment - Drugs

2

Description
Control group: Midazolam inf. for 10 min, propofol 0.5 mg/kg and fentanyl bolous
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Dr. Reza Baghbanian
Street address
24 metery street, east sahely highway, ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3985
Email
Baghbanian.r@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
24 metery street, East sahely highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3985
Email
Baghbanian.r@ajums.ac.ri
Web page address
http://vchresearch.ajums.ac.ir/fa-IR/vchresearch.ajums.ac/4937/page/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C-%D9%85%D8%B9%D8%A7%D9%88%D9%86%D8%AA
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Baghbanian
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
24 metery street, east sahely highway, ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3985
Email
baghbanian.r@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Baghbanian
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
24 metery street, east sahely highway, ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3985
Email
baghbanian.r@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Baghbanian
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
24 metery street, east sahely highway, ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3985
Email
baghbanian.r@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
crude data file , export analysis file and patient consent form will be available
When the data will become available and for how long
6 month after publish
To whom data/document is available
data files after research and development Vice-chancellor permission will be available for researcher and academic organization
Under which criteria data/document could be used
after research and development Vice-chancellor permission accept DATA file will be send
From where data/document is obtainable
send request from research and development Vice-chancellor web page
What processes are involved for a request to access data/document
send request letter, evaluation in committee, permission issuance, send data file
Comments
Loading...