We aim to compare the effect of dexmedetomidine and remifentanil on postoperative sedation score and postoperative pain after general anesthesia with sevoflurane.
Design
In the present double-blind clinical trial, which will be carried out in a parallel way, a total of 90 children who candidate for strabismus surgery under general anesthesia with sevoflurane will be enrolled in the study. Eligible patients will be randomly allocated into three equal A, B and C groups by simple randomization.
Settings and conduct
This study will be done in operating room. All of the drugs solution (dexmedetomidine, remifentanil and placebo) of this study will be prepared in 10 ml syringes that are the same in shape by only one person who is aware of study's grouping. Anesthesiologist, patients and all medical stuffs that will collaborate in the study will not aware of the drug allocated to each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who will candidate for strabismus surgery under general anesthesia with sevoflurane. Non-inclusion criteria: history of: renal disease; liver disease; use of sedative drugs; mental retardation ;psychiatric disorder; allergy to drugs will be used in this study; those who needs rapid sequence induction
Intervention groups
Intervention group 1: this group will be received an IV infusion of dexmedetomidine 0.1 mcg/Kg over five minutes with a 10 ml syringe with the label A. Intervention group 2: patients in this group will receive IV infusion of remifentanyl, 0.1 mcg/Kg over five minutes with a 10 ml syringe with the label B. Control group: patients in this group will receive IV infusion of physiologic saline with a 10 ml syringe with the label C over five minutes.
Main outcome variables
Intraoperative hemodynamic parameters, emergence of agitation, postoperative pain, satisfaction of recovery stuff from children condition
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121204011662N14
Registration date:2020-03-28, 1399/01/09
Registration timing:prospective
Last update:2020-03-28, 1399/01/09
Update count:0
Registration date
2020-03-28, 1399/01/09
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
2020-04-20, 1399/02/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of Dexmedetomidine and remifentanil on emergence of agitation in children with sevoflurane anesthesia
Public title
Comparison the effects of two anesthetic drugs on agitation of children after anesthesia.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who will candidate for strabismus surgery under general anesthesia
Exclusion criteria:
Patients with history of congenital heart disease
Patients with history of renal disease
Patients with history of liver disease
Patients who needs rapid sequence induction
Patients with history use of sedative drugs
Patients with history of mental retardation
Patients with history of psychiatric disorder
Patients with history of allergy to drugs will be used in this study.
Age
From 2 years old to 7 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly allocated into three groups by block randomization. In this technique, permutation block of size 6 will be made for patients of three groups A, B & C. In each block equal numbers for three groups will be considered in alternative positions. Then 15 blocks of size 6 will be selected randomly and
patients will be allocated randomly and equally into three groups according to these permutation block.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blindness, All of the drugs solution (dexmedetomidine, remifentanil and normal saline) of this study will be prepared in 10 ml syringes that are similar and equal in shape, by a nurse of anesthesia who is aware of patients' grouping. These syringes will have label A , B or C. Anesthesiologist who will use these syringes will not aware of the content of these syringes, and just will use syringes with label A for patients in group A, syringes with label B for patients in group B and syringes with label C for patients in group C. Patients and all medical stuffs who will collaborate in data gathering, will not be aware of the content of these syringes.
Placebo
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
2020-02-24, 1398/12/05
Ethics committee reference number
IR.SUMS.MED.REC.1398.647
Health conditions studied
1
Description of health condition studied
Post operative agitation in children
ICD-10 code
R45.1
ICD-10 code description
Restlessness and agitation
Primary outcomes
1
Description
Postoperative agitation
Timepoint
At times: 0, 10 min, 20 min , 30 min after arrival in recovery room.
Method of measurement
Pediatric anesthesia emergence delirium scale .
2
Description
Postoperative pain severity
Timepoint
At times: 0, 10 min, 20 min , 30 min after arrival in recovery room.
Method of measurement
Children and infants postoperative pain scale
Secondary outcomes
1
Description
Mean arterial blood pressure (MAP)
Timepoint
Preoperative, Intraoperative, Postoperative.
Method of measurement
Non invasive blood pressure monitoring by digital blood pressure measuring of monitoring system.
2
Description
Heart rate per minute
Timepoint
Preoperative, Intraoperative, Postoperative.
Method of measurement
Electrocardiogram
3
Description
Satisfaction of the recovery room stuff from children condition.
Timepoint
At the end of recovery stay.
Method of measurement
Patient's files and records
Intervention groups
1
Description
Intervention group 1: At the end of anesthesia, patients in group A will receive IV dexmedetomidine 0.1 mcg /Kg over five minutes with a 10 ml syringe with the label A.
Category
Treatment - Drugs
2
Description
Intervention group 2: At the end of anesthesia, patients in group B will receive IV infusion of remifentanyl 0.1 mcg/Kg over five minutes with a 10 ml syringe with the label B.
Category
Treatment - Drugs
3
Description
Control group: At the end of anesthesia, patients in group C will receive 10 ml of IV normal saline over five minutes with a 10 ml syringe with the label C.
Category
Placebo
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 boulevard
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?