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Comparative study of the effect of "ketamine-midazolam" with "ketamine-dexmedetomidine" on sedation, pain, and hemodynamic changes in patients candidate for fiberoptic bronchoscopy

Protocol summary

Study aim
Determining and comparing the effect of "ketamine-midazolam" with "ketamine-dexmedetomidine" on sedation, pain, and hemodynamic changes in patients candidate for fiberoptic bronchoscopy
Design
A randomized double-blind clinical trial, with the parallel groups
Settings and conduct
This randomized double-blind clinical trial is carried out at Al-Zahra Hospital in Isfahan. In this study, 66 candidates for fiberoptic bronchoscopy will be admitted and randomly divided into 2 parallel groups. Then for these two groups, "ketamine-midazolam" and "ketamine-dexmedetomidine" will be administered, respectively.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients who are candidates for bronchoscopy and ASA I and II. Exclusion criteria included taking painkillers and opioids 24 hours before surgery, taking beta-blocker before the study, muscle weakness, drug allergies, and asthma, as well as patients with a history of cardiovascular disease, kidney disease, liver disease, chronic respiratory disease, immunodeficiency, people who have consumed alcohol 24 hours before surgery, and people with heart blocks and conduction disorders of the heart.
Intervention groups
First, for all patients, 2% lidocaine(Caspian-Tamin Company) is sprayed onto the vocal cords. For all patients, nasal oxygen with a flow of 2 liters per minute is installed. Patients in the first group receive 1 mg/kg ketamine(Caspian-Tamin Company) and 1 μg/kg dexmedetomidine(Caspian-Tamin Company) for 10 minutes and the infusion of 0.5 mg/min ketamine and 0.5 μg/kg dexmedetomidine. Patients in the second group receive 1 mg/kg ketamine and 2.5 mg midazolam (Caspian-Tamin Company) over ten minutes and are also given an infusion of 0.5 mg/min ketamine and a 25% starting dose of midazolam.
Main outcome variables
Sedation level; pain and hemodynamic parameters

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200825048515N13
Registration date: 2020-12-03, 1399/09/13
Registration timing: registered_while_recruiting

Last update: 2020-12-03, 1399/09/13
Update count: 0
Registration date
2020-12-03, 1399/09/13
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of "ketamine-midazolam" with "ketamine-dexmedetomidine" on sedation, pain, and hemodynamic changes in patients candidate for fiberoptic bronchoscopy
Public title
Comparing the effect of "ketamine-midazolam" with "ketamine-dexmedetomidine" on hemodynamic changes in patients candidate for fiberoptic bronchoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for bronchoscopy The American Society of Anesthesiologists (ASA) Physical Status Classification equal I or II Being consent to participate in the study
Exclusion criteria:
Taking painkillers and opioids 24 hours before surgery Taking beta-blockers before the study Allergy to medications Asthma History of cardiovascular disease History of kidney disease History of liver disease History of chronic respiratory disease History of immunodeficiency Consuming alcohol 24 hours before surgery People with heart block and conduction disorders Having muscle weakness
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In a double-blind trial, two drug-combinations will be prepared by the anesthesiologist before the intervention begins. All medicines will be provided in the same volume with the aid of distilled water. These syringes will be labeled and given to the researcher on a daily basis, and they will be administered without knowing the type of each drug. In addition, the patient (due to lack of consciousness) will not know the type of intervention. The statistical analyst will not be aware of the type of intervention.
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
Hezar Jarib Ave, Azadi Square.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-08, 1399/05/18
Ethics committee reference number
IR.MUI.MED.REC.1399.376

Health conditions studied

1

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

Primary outcomes

1

Description
Sedation level
Timepoint
Two minutes after bolus injection
Method of measurement
Ramsay Sedation Scale

2

Description
Pain
Timepoint
Immediately, 10, 20 and 30 minutes after consciousness
Method of measurement
Visual Analog Scale (VAS)

3

Description
Blood pressure
Timepoint
Before the intervention, immediately, 10, 20 and 30 minutes after the intervention
Method of measurement
Monitoring device

4

Description
Heart rate
Timepoint
Before the intervention, immediately, 10, 20 and 30 minutes after the intervention
Method of measurement
Monitoring device

5

Description
Oxygen saturation percentage (SPO2)
Timepoint
Before the intervention, immediately, 10, 20 and 30 minutes after the intervention
Method of measurement
Monitoring device

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: First, for all patients, 2% lidocaine(Caspian-Tamin Company) is sprayed onto the vocal cords. For all patients, nasal oxygen with a flow of 2 liters per minute is installed. Patients in the first intervention group receive 1 mg/kg ketamine(Caspian-Tamin Company) and 1 μg/kg dexmedetomidine(Caspian-Tamin Company) for 10 minutes and the infusion of 0.5 mg/min ketamine and 0.5 μg/kg dexmedetomidine.
Category
Treatment - Drugs

2

Description
Second intervention group: First, for all patients, 2% lidocaine (Caspian-Tamin Company) is sprayed onto the vocal cords. For all patients, nasal oxygen with a flow of 2 liters per minute is installed. Patients in the second group receive 1 mg/kg ketamine (Caspian-Tamin Company) and 2.5 mg midazolam (Caspian-Tamin Company) over ten minutes and are also given an infusion of 0.5 mg/min ketamine and a 25% starting dose of midazolam.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Anesthesiology Department, Al-Zahra Hospital, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan 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
Behzad Nazemroaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Hezar Jerib Street, Al-Zahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behzad Nazemroaya
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Al-Zahra Hospital, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
behzad_nazem@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samin Jahanbin
Position
Non-faculty physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Alley 21, Sepahan Shahr
City
Isfahan
Province
Isfehan
Postal code
8139946511
Phone
0098 31 362011111
Email
samin.jahanbin73@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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