Effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after general anesthesia, in upper GI endoscopy in pediatric patients
ِDeterminig the effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after general anesthesia, in upper GI endoscopy in pediatric patients
Design
Randomized, two arm parallel group trial with blinded outcome assessment and postoperative care.
Settings and conduct
Based on the inclusion and exclusion criteria, 98 children aged 2 to 14, candidate for an elective upper GI endoscopy are selected, and after an informed consent is taken from their parents, are randomly divided into two groups. In both groups standard monitoring devices will be installed. after preoxigenation with 100% O2, anesthesia is inducted with 2.5 mg/kg Nesdonal and deepened with Sevoflurane. Before starting endoscopy in the intervention group 0/1 mg/kg IV Dexamethasone and in the control group 2cc IV normal saline will be administered. Postoperatively, data on incidence of Nausea/vomiting and other outcomes will be collected in the recovery room, by an investigator who is blinded to the intervention allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All 2 to 14 year-old children, who are a candidate for an elective upper GI endoscopy, and whose parents have given an informed consent; Exclusion criteria: Patients with a history of hypersensitivity to the drugs studied, metabolic disease or diabetes, anatomical upper airway disorders, Patients diagnosed with behavioral disorders or currently taking psychiatric medication, patients who have previously undergone chemotherapy or have taken a sedative/hypnotic drug prior to endoscopy, Patients who are a candidate for an emergency endoscopy or whose operation is complicated and takes too long to be completed
Intervention groups
For intervention group 0/1 mg/kg IV Dexamethasone, and for control group 2cc IV normal saline will administered before operation.
Main outcome variables
Frequency of nausea/vomiting after endoscopy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180929041173N1
Registration date:2018-10-26, 1397/08/04
Registration timing:prospective
Last update:2018-10-26, 1397/08/04
Update count:2
Registration date
2018-10-26, 1397/08/04
Registrant information
Name
Hamed Moheimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 81631
Email address
h-moheimani@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-03, 1397/08/12
Expected recruitment end date
2018-11-13, 1397/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of intravenous Dexamethasone on the incidence of nausea and vomiting after general anesthesia, in upper GI endoscopy in pediatric patients
Public title
Antiemetic effect of Dexamethasone in pediatric endosocopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All 2 to 14 year-old children, candidate for an elective upper GI endoscopy, according to the pediatric gastroenterologist diagnosis
Exclusion criteria:
Patients with a history of hypersensitivity to the drugs studied
Patients with a history of metabolic disease or diabetes
Patients with anatomical upper airway disorders
Patients diagnosed with behavioral disorders or currently taking psychiatric medication
Patients with a history of undergoing chemotherapy
Patients who have taken a sedative/hypnotic drug prior to endoscopy
Patients who are a candidate for an emergency endoscopy
Patients whose operation is complicated (e.g. by bleeding) and takes too long to be completed
Patients without a parental informed consent
Age
From 2 years old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
A statistical computer program is used to make random block stratified individual assignments with user selected block sizes. The psuedonumber generator is a linear congruential algorithm of Park and Milller with Bays-Durham shuffling. The random sheets will be given directly to nurse administrating the drugs and neither the participants nor the researcher collecting the data will be informed of the method of drug allocation to patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
The randomly allocated list of patients will be given exclusively to the nurse administrating the drugs. Participants, gastroenterologist performing endoscopy, attending anesthesiologist, recovery nurse and the researcher collecting data will not be informed of the method of drug allocation to patients.
(The parents of participants will be thoroughly informed that this clinical trial uses a randomized method before giving consent)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-10-17, 1397/07/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.505
Health conditions studied
1
Description of health condition studied
Post endoscopy nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Frequency of patients with nausea/vomiting
Timepoint
Recording the frequency of patients with nausea/vomiting, evaluated from their entry time to the post-anesthesia recovery room, until the time they are discharged
Method of measurement
Investigator evaluation and examination
Secondary outcomes
1
Description
Post anesthesia emergence delirium
Timepoint
Recording the highest score of patients on PAED sacle, from their time of entry to the post-anesthesia recovery room until they are discharged
Recording the frequency of patients with bronchospasm/laryngospasm, evaluated from their entry time to the post-anesthesia recovery room, until the time they are discharged
Method of measurement
Investigator evaluation and examination
3
Description
Time needed for patient recovery after endoscopy
Timepoint
Recording the time of patients stay in the post-anesthesia recovery room after endoscopy, until being eligible for discharge
Method of measurement
Subtracting the recorded time of entry to the recovery room, from the time the patient is eligible for discharging
4
Description
Patients competency assessment for discharge
Timepoint
Patients score on the Modified Aldrete scale is calculated and recorded at the time of entry to post-anesthesia recovery room, 20 minutes after entry, and at the time of discharge
Method of measurement
Modified Aldrete scale
Intervention groups
1
Description
Intervention group: After anesthesia is inducted and deepened, 0/1 mg/(kg of body weight) of Dexamethasone is administered to patients intravenously
Category
Treatment - Drugs
2
Description
Control group: After anesthesia is inducted and deepened, 2cc of normal saline is administered to patients intravenously
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Childrens Medcial Center hospital
Full name of responsible person
Hamed Moheimani
Street address
Tehran Childrens Medical Center hospital, number 62, Gharib st., Keshavarz blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1479733151
Phone
+98 21 6147 2917
Email
h-moheimani@student.tums.ac.ir
Web page address
http://chmc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Fax
+98 21 8163 3623
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hamed Moheimani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 81631
Fax
+98 21 8163 3047
Email
h-moheimani@student.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Moheimani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 81631
Fax
+98 21 8163 3047
Email
h-moheimani@student.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamed Moheimani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
Internal Medicine
Street address
Central office of Tehran University of Medical sciences, on the corner of Qods st., Keshavarz Boulevard, Tehran, Iran. PC: 1417653761
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۵۳۷۶۱
Phone
+98 21 81631
Fax
+98 21 8163 3047
Email
h-moheimani@student.tums.ac.ir
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available