1. Home
  2. Approved trials
  3. » فارسی

Comparison of the effect of midazolam-ketamine with ketamine-propofol on post-tonsillectomy agitation in children

Protocol summary

Study aim
Comparison of the effect of midazolam-ketamine with ketamine-propofol on post-tonsillectomy agitation in children
Design
Double-blind randomized clinical trial
Settings and conduct
Intervention 1: The 1st group will receive ketamine 0.5 mg/kg/IV and midazolam 0.01 mg/kg/IV, 10 minute before the end of the surgery. Intervention2: The second group will receive propofol 1 mg/kg/IV and ketamine 0.5 mg/kg, 10 minute before the end of the surgery. Intervention3: The third group received ketamine 0.5 mg/kg/IV, 10 minute before the end of the surgery.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: ASA I-II, Airway class I-II, Normal BMI, children (aged 5-15) scheduled for elective adenotonsillectomy, (ASA Class 1 and 2), isoflurane based anesthesia. Exclusion Criteria: Past history of neuropsychiatric illness, CHD, URTI, seizure, drug reactions. Any past history of post operation complications. Also children with any complication of surgery or anesthesia that could cause agitation itself.
Intervention groups
Intervention 1: The 1st group will receive ketamine 0.5 mg/kg/IV and midazolam 0.01 mg/kg/IV, 10 minute before the end of the surgery. Intervention2: The second group will receive propofol 1 mg/kg/IV and ketamine 0.5 mg/kg, 10 minute before the end of the surgery. Intervention3: The third group received ketamine 0.5 mg/kg/IV, 10 minute before the end of the surgery.
Main outcome variables
Pain,Sedation,PACU duration.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141009019470N92
Registration date: 2020-01-06, 1398/10/16
Registration timing: prospective

Last update: 2020-01-06, 1398/10/16
Update count: 0
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-04, 1398/11/15
Expected recruitment end date
2020-04-03, 1399/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of midazolam-ketamine with ketamine-propofol on post-tonsillectomy agitation in children
Public title
Comparison of the effect of midazolam-ketamine with ketamine-propofol on post-tonsillectomy agitation in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I-II Airway class I-II Normal BMI children aged 5-15 children candidate for elective adenotonsillectomy Isoflurane based anesthesia
Exclusion criteria:
History of neuropsychiatric illness CHD URTI Seizure Drug reactions Any history of post operation complications Any complication of surgery or anesthesia that could cause agitation itself
Age
From 5 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
These children will be randomly divided into 3 groups of 50 cases based on randomization chart which is derived from www.randomization.org.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assistant anesthesiologist who’s not involved in the data collection will prepare the syringe for each patient. Anesthesia nurse who is present in the operating room will not provide any information to the recovery staff after the surgery and deliver the patient to the recovery room, while, the patient, nurse, recovery officer, and data analyst will be briefed on the study. Have been
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2018-02-22, 1396/12/03
Ethics committee reference number
IR.SUMS.MED.REC.1396.86

Health conditions studied

1

Description of health condition studied
Tonsillectomy
ICD-10 code
J35.01
ICD-10 code description
Chronic tonsillitis

Primary outcomes

1

Description
Sedation
Timepoint
At arrival to recovery room 5 minute, 10 minute, 20 minute and on recovery room discharge.
Method of measurement
Richmond Agitation & Sedation Scale (RASS)

2

Description
Pain
Timepoint
At arrival to recovery room 5 minute, 10 minute, 20 minute and on recovery room discharge.
Method of measurement
Objective Pain Scale (OPS)

3

Description
Recover duration
Timepoint
At arrival to recovery room 5 minute, 10 minute, 20 minute and on recovery room discharge.
Method of measurement
Modified Aldrete score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The 1st group will receive ketamine 0.5 mg/kg and midazolam 0.01 mg/kg, 10 minute before the end of the surgery.
Category
Prevention

2

Description
Intervention group: The second group will receive propofol 1 mg/kg and ketamine 0.5 mg/kg, 10 minute before the end of the surgery.
Category
Prevention

3

Description
Intervention group: The third group received ketamine 0.5 mg/kg, 10 minute before the end of the surgery.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Rezvan Haghighat
Street address
Khalili Street, Khalili Hospital
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶-۷۱۳۴۸
Phone
+98 71 3627 1671
Email
Khalili.hos@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Rezvan Haghighat
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
HAGHIGHAT@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zeinabsadat Fatahi Saravi
Position
Anesthesiolgist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
parniafattahi@rocketmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.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
Its against our policies.
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
Loading...