We aim to compare the effect of dexmedetomidine with remifentanil on hemodynamics parameters, , propofol consumption and postoperative respiratory depression, sedation score, postoperative pain and nausea& vomiting during direct laryngoscopy.
Design
In the present double-blind clinical trial, which will be carried out in a parallel way, a total of 60 patients who candidate for direct laryngoscopy will be enrolled in the study. Eligible patients will be randomly allocated into two equal A, and B groups by simple randomization .
Settings and conduct
This study will be done in operating room.All of the drugs solution( dexmedetomidine and remifentanil) of this study will be prepared in 20 ml syringes that are equal in shape will be made by only person who aware of study's groups .Anesthesiologist, patients, all medical stuffs who will collaborated in the study will not aware of patients groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 60 patients who will candidate for direct laryngoscopy will be enrolled. Exclusion criteria: Patients with history of ischemic heart disease; heart failure; asthma; renal failure; hepatic failure; emergency cases and who are morbidly obese will exclude from study.
Intervention groups
Patients in group A will be received an IV infusion of dexmedetomidine 1 mcg/Kg over five minutes with a 20 ml syringe with the label A and patients in group B will be received an IV infusion of remifentanyl 1 mcg/Kg over five minutes with a 20 ml syringe with the label B.
Main outcome variables
Intraoperative hemodynamic, and postoperative respiratory depression, sedation score, postoperative pain and nausea& vomiting will record .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121204011662N13
Registration date:2020-02-17, 1398/11/28
Registration timing:registered_while_recruiting
Last update:2020-02-17, 1398/11/28
Update count:0
Registration date
2020-02-17, 1398/11/28
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Dexmedetomidine and Remifentanil in the Anesthesia for Direct Laryngoscopy: A Randomized Clinical Trial
Public title
Comparison of quality anesthesia of two anesthetic drugs in direct laryngoscopy.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who will candidate for direct laparoscopy under general anesthesia will be enrolled.
Exclusion criteria:
Patients with history of ischemic heart disease
Patients with history of heart failure
Patients with history of asthma
Patients with history of renal failure
Patients with history of hepatic failure
Patients who are morbidly obese
Patients in emergency situation
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into two groups A & B, according to randomization numbers table using quadratic permutation blocks that will derive from randomization.org.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blindness, All of the drugs solution( dexmedetomidine and remifentanil) of this study will be prepared in 20 ml syringes that are similar and equal in shape , by a nurse of anesthesia who aware of patients' study's groups.These syringes will have label A or B. Anesthesiologist who will use these syringes will not aware of the content of this syringes, just use syringes with label A for patients in group A and syringes with label B for patients in group B. Patients and all medical stuffs who will collaborate in data gathering , will not aware of the content of this syringes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz Medical School
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
197871345
Approval date
2019-12-16, 1398/09/25
Ethics committee reference number
IR.SUMS.MED.REC.1398.519
Health conditions studied
1
Description of health condition studied
Survey of anesthesia for direct laryngoscopy.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Mean arterial blood pressure (MAP)
Timepoint
Values will record at baseline, 5, 10, 15, 30, and 45, minutes.
Method of measurement
Non invasive blood pressure monitoring.
2
Description
Heart rate per minute
Timepoint
Values will record at baseline, 5, 10, 15, 30, and 45, minutes.
Method of measurement
Electrocardiogram
Secondary outcomes
1
Description
Sedation Score
Timepoint
Every 15 minutes in recovery room.
Method of measurement
Ramsay Scale
2
Description
Attacks of respiratory depression
Timepoint
Every 15 minutes in recovery room.
Method of measurement
Defined as a respiratory rate < 8 breaths/min.
3
Description
Incidence of nausea and vomiting
Timepoint
Every 15 minutes in recovery room.
Method of measurement
0: No nausea and vomiting, 1: Nuasea without Vomiting, 2: Both Nausea and Vomiting.
4
Description
Severity of postoperative pain
Timepoint
Every 15 minutes in recovery room.
Method of measurement
Visual analogue Scale
Intervention groups
1
Description
Intervention group 1: After induction of anesthesia,patients in group Awill be received an IV infusion of dexmedetomidine 1 mcg/Kg over five minutes with a 20 ml syringe with the label A.
Category
Treatment - Drugs
2
Description
Intervention group 2: After induction of anesthesia,patients in group B will be received an IV infusion of remifentanyl 1 mcg/Kg over five minutes with a 20 ml syringe with the label B.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili training and medical center
Full name of responsible person
Mohamma Ali Sahmeddini
Street address
Khalili Avenue
City
Shiraz
Province
Fars
Postal code
1135171937
Phone
+98 71 3629 1495
Fax
+98 71 3629 1671
Email
khalili@sums.ac.ir
Web page address
http://khalili.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Shiraz University Of Medical Sciences building, Zand Blvd.
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?