Protocol summary

Study aim
The comparative Evaluation of Efficacy of intravenous lidocaine 2% and propofol in preventing laryngospasm and complications after tonsilectomy
Design
102 children aged 3-14 years admitted for adenotonsillectomy randomly assigned into 5 blocks in a randomized, double blind randomized clinical trial, in one of the two intravenous administration of lidocaine 2% and propofol.
Settings and conduct
In this study, children aged 3 to 14 years were candidates for adenotonsillectomy who will be referred to the Fatemiyeh Hospital of Hamedan during the study period, will be randomly assigned to randomized allocation blocks by random sampling.
Participants/Inclusion and exclusion criteria
Inclusin Criteria: Aged 3-14 years old; Candidate for elective adenotonsilectomy; Parental Satisfaction Exclusion Criteria: Those who are reluctant to continue to participate in the study; History of Cardio-pulmonary disease; Recent infection of the upper respiratory tract and febrile illnesses; History of allergy to eggs, soy, lidocaine and propofol; difficult intubation; Corticosteroid use
Intervention groups
Intervention group 1: Children aged 3 to 14 years old are candidates for adenotonsillectomy, which will receive 2 mg / kg Lidocaine for two minutes prior to extubation. Intervention group 2: Children aged 3 to 14 years old are candidates for adenotonsillectomy, which will receive propofol 0.5 mg / kg for two minutes prior to extubation.
Main outcome variables
Laryngospasm

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120915010841N16
Registration date: 2019-04-24, 1398/02/04
Registration timing: registered_while_recruiting

Last update: 2019-04-24, 1398/02/04
Update count: 0
Registration date
2019-04-24, 1398/02/04
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2020-04-08, 1399/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative Evaluation of Efficacy of intravenous lidocaine 2% and propofol in preventing laryngospasm and complications after tonsilectomy
Public title
Efficacy of intravenous lidocaine 2% and propofol in preventing laryngospasm
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 3-14 years old Candidate for elective adenotonsilectomy Parental Satisfaction
Exclusion criteria:
Those who are reluctant to continue to participate in the study History of Cardio-pulmonary disease Recent infection of the upper respiratory tract and febrile illnesses History of allergy to eggs, soy, lidocaine and propofol difficult intubation Corticosteroid use
Age
From 3 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 102
Randomization (investigator's opinion)
Randomized
Randomization description
we provide ten paper sheets . We write five letters A and on five other sheets of letter B. We mix the papers together and put them in the drawer of the table.With each of the qualified patients, one of the papers is taken out randomly and, According to the text, the patient is given one of two groups: A (Propofol) and B (Lidocaine). Then, for ten subsequent patients, the paper is returned to the bag again, and this process is repeated until the end of the sample volume.
Blinding (investigator's opinion)
Double blinded
Blinding description
In both groups A and B, medications (propofol or lidocaine) will be prescribed two minutes before the extubation of the chip. In order to prevent the medication being detectable for patients and investigators, they are prepared and injected into syringes of the same size and shape and on the adhesives A and B by the anesthetist. Since drugs are prescribed and prescribed by an anesthetist, the clinician will not be aware of the type of prescribed medication that will measure and record the outcome of the study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Hamadan university of medical sciences
Street address
Mahdieh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2018-12-01, 1397/09/10
Ethics committee reference number
IR.UMSHA.REC.1397.628

Health conditions studied

1

Description of health condition studied
laryngospasm and complications after tonsilectomy
ICD-10 code
J38.5
ICD-10 code description
Laryngeal spasm

Primary outcomes

1

Description
laryngospasm
Timepoint
1, 3, 5, 10 and 15 minutes after extubation
Method of measurement
Observation

Secondary outcomes

1

Description
Nausea & vomiting
Timepoint
After surgery
Method of measurement
Observation

2

Description
Systolic and Diastolic Blood Pressure
Timepoint
Every two minutes for 10 minutes and then every 10 minutes to 60 minute
Method of measurement
Non-invasive automatic barometric device

3

Description
Heart Rate
Timepoint
Every two minutes for 10 minutes and then every 10 minutes to 60 minute
Method of measurement
Non-invasive automatic barometric device

Intervention groups

1

Description
Intervention group: Children aged 3 to 14 years old are candidates for adenotonsillectomy, which will receive 1 mg / kg of lidocaine 2%, two minutes before extubation.
Category
Prevention

2

Description
Intervention group: Children aged 3 to 14 years old are candidates for adenotonsillectomy, which will receive 0.5 mg / kg propofol two minutes before to extubation.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Nahid Manouchehrian, Anesthesiologist, Assistant Professor of Hamadan University Of Medical Sciences
Street address
Besat Hospital in Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
hp.besat@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate Professor of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 918 111 0366
Email
manuchehriann@gmail.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
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