Comparison of the Effects of Dexmedetomidine and Fentanyl-Midazolam Combination on Mitigating Stress Response for Microlaryngoscopy: A Randomized, Double-Blind, Clinical Trial
This study compared the effect of dexmedetomidine and Fentanyl-Midazolam on attenuation of the hemodynamic stress response in patients scheduled for microlaryngoscopy.
Design
Double-blind, randomized, clinical trial with 2 intervention groups, with parallel groups, on 60 patients.
Settings and conduct
Candidates for Microlaryngoscopy in Magrabi Eye, ENT and Dental Center, Doha, Qatar are divided into 2 groups. The groups are parallel. The trial phase is 2-3.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18-65 years ASA grade I/III Scheduled for microlaryngoscopy
Exclusion criteria: patients with known allergy to study drugs Coronary artery disease Pulmonary disease Arrhythmia Pregnancy Renal impairment
Intervention groups
Group I: 1 µg/kg of dexmedetomidine over 10 minutes before anesthesia induction followed by 0.05 mg/kg/h as infusion after anesthesia induction (group D).
Group II: 0.8 µg/kg fentanyl plus 0.05 mg/kg midazolam over 10 minutes before anesthesia induction followed by 1 µg/kg/h fentanyl and 0.05 mg/kg/h midazolam as infusion after anesthesia induction (group MF)
Main outcome variables
Hemodynamic stress response
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210117050057N2
Registration date:2021-03-19, 1399/12/29
Registration timing:prospective
Last update:2021-03-19, 1399/12/29
Update count:0
Registration date
2021-03-19, 1399/12/29
Registrant information
Name
Mohamed Oriby
Name of organization / entity
Faculty of Medicine, Tanta University
Country
Egypt
Phone
+20 3 3059056
Email address
oraiby500@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-25, 1400/01/05
Expected recruitment end date
2021-06-01, 1400/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Dexmedetomidine and Fentanyl-Midazolam Combination on Mitigating Stress Response for Microlaryngoscopy: A Randomized, Double-Blind, Clinical Trial
Public title
Comparison of the Effects of Dexmedetomidine and Fentanyl-Midazolam Combination on Mitigating Stress Response for Microlaryngoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-65 years
ASA grade I/III
Scheduled for microlaryngoscopy
Exclusion criteria:
Patients with known allergy to study drugs
Coronary artery disease
Pulmonary disease
Arrhythmia
Pregnancy
Renal impairment
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to one of two groups using computer-generated software of randomization introduced into sealed opaque envelops which are sequentially numbered.
Blinding (investigator's opinion)
Double blinded
Blinding description
An independent nurse, who did not participate in the study or data collection prepared all study drugs. These drugs were administered by another nurse who was blind to the study and the groups. The anesthesiologist, surgeon and data collectors were all blinded to the given study drugs and the envelops were opened immediately before administration by a person who did not participate in the observation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board (IRB) of Magrabi Eye & ENT Center
Street address
D ring road
City
Doha
Postal code
23293
Approval date
2021-03-13, 1399/12/23
Ethics committee reference number
MEEC-IRB- 2021-103
Health conditions studied
1
Description of health condition studied
Microlaryngoscopy
ICD-10 code
J38.7
ICD-10 code description
Other diseases of larynx
Primary outcomes
1
Description
Hemodynamic stress response
Timepoint
Intraoperative
Method of measurement
Systolic Blood Pressure , Mean Arterial Pressure, Heart Rate were monitored
Secondary outcomes
1
Description
Intraoperative requirement of propofol
Timepoint
Intraoperative
Method of measurement
Total dose guided by bispectral index
2
Description
Sedation
Timepoint
Postoperative
Method of measurement
Ramsay score
3
Description
Analgesia
Timepoint
Postoperative
Method of measurement
Visual Analogue Scale
4
Description
Anesthesia duration
Timepoint
Intraoperative
Method of measurement
Time measurement
5
Description
Recovery time
Timepoint
Postoperative
Method of measurement
Time measurement
Intervention groups
1
Description
Dexmedetomidine group: 30 patients who received 1 µg/kg of dexmedetomidine over 10 minutes before anesthesia induction followed by 0.05 mg/kg/h as infusion after anesthesia induction
Category
Treatment - Drugs
2
Description
Fentanyl-Midazolam group: 30 patients received fentanyl 0.8 µg/kg plus midazolam 0.05 mg/kg over 10 minutes before anesthesia induction followed by 1 µg/kg/h fentanyl and 0.05 mg/kg/h midazolam as infusion after anesthesia induction
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Magrabi Eye, ENT and Dental Center, Doha, Qatar
Full name of responsible person
MOHAMED ORIBY
Street address
D ring road
City
Doha
Postal code
23293
Phone
+974 4437 5046
Email
oraiby500@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Magrabi Eye, ENT and Dental Center, Doha, Qatar
Full name of responsible person
Magrabi Eye, ENT and Dental Center, Doha, Qatar
Street address
D ring road
City
Doha
Postal code
23293
Phone
+974 4437 5046
Email
oraiby500@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Magrabi Eye, ENT and Dental Center, Doha, Qatar
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Medicine, Tanta University
Full name of responsible person
MOHAMED ORIBY
Position
Lecturer of Anesthesiology
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Tanta
City
Tanta
Province
Gharbeya
Postal code
00000
Phone
+974 3305 9056
Email
oraiby500@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Medicine, Tanta University
Full name of responsible person
MOHAMED ORIBY
Position
Lecturer of Anesthesiology
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Tanta
City
Tanta
Province
Gharbeya
Postal code
00000
Phone
+974 3305 9056
Email
oraiby500@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Medicine, Tanta University
Full name of responsible person
MOHAMED ORIBY
Position
Lecturer of Anesthesiology
Latest degree
Ph.D.
Other areas of specialty/work
Anesthesiology
Street address
Tanta
City
Tanta
Province
Gharbeya
Postal code
00000
Phone
+974 3305 9056
Email
oraiby500@hotmail.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