Comparison of the effect of nasal dexamethasone on post strabismus surgery nausea and vomiting prevention in adults
Design
Clinical trials in two community-based and pragmatic groups with parallel blinded, randomized, 30-person groups
Settings and conduct
Using intranasal Dexamethasone and Saline with a specific dose in two groups and comparing its effect on reducing nausea and vomiting after strabismus surgery in Feyz ophthalmology center of Isfahan, the patient and researcher are unaware of which drug is used for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2; Age between 18 to 65 years; Candidate for strabismus surgery; filled informed consent form. Exclusion criteria: patients with motion sickness; taking anti emetic drugs during last 24 hours before surgery; patient under treatment with opioid drugs; smokers; pregnant women.
Intervention groups
Recipient of Dexamethasone (D) and Saline (S)
Main outcome variables
Severity of nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N12
Registration date:2020-03-19, 1398/12/29
Registration timing:prospective
Last update:2020-03-19, 1398/12/29
Update count:0
Registration date
2020-03-19, 1398/12/29
Registrant information
Name
Hamidreza Shetabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
hamidshetabi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2020-09-06, 1399/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of nasal dexamethasone on post strabismus surgery nausea and vomiting prevention in adults
Public title
the effect of nasal dexamethasone on post strabismus surgery nausea and vomiting prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2
Age between 18 to 65 years
Candidate for strabismus surgery
filled informed consent form
Exclusion criteria:
patients with motion sickness
taking anti emetic drugs during last 24 hours before surgery
patient under treatment with opioid drugs
smokers
pregnant women
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation to intervention and control groups using Random allocation software
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind clinical trial, the patient and the observer who records datas are unaware of patients groups and drugs which are being studied.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Blvd.
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2020-02-01, 1398/11/12
Ethics committee reference number
IR.MUI.MED.REC.1398.563
Health conditions studied
1
Description of health condition studied
post operative nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Incidence of nausea
Timepoint
2 and 24 hours after entering recovery
Method of measurement
Visual Analogue Scale
2
Description
Score of nausea
Timepoint
2 and 24 hours after entering recovery
Method of measurement
Visual Analogue Scale
3
Description
Incidence of vomiting
Timepoint
2 and 24 hours after entering recovery
Method of measurement
scoring system for vomiting
4
Description
Score of vomiting
Timepoint
2 and 24 hours after entering recovery
Method of measurement
scoring system for vomiting
5
Description
Incidence of pain
Timepoint
2 and 24 hours after entering recovery
Method of measurement
Visual Analogue Scale
6
Description
Score of pain
Timepoint
2 and 24 hours after entering recovery
Method of measurement
Visual Analogue Scale
7
Description
First time using anti emetic drug
Timepoint
24 hours after entering recovery
Method of measurement
Clock
8
Description
Total dose of anti emetic
Timepoint
24 hours after entering recovery
Method of measurement
file
9
Description
Total dose of analgesic
Timepoint
24 hours after entering recovery
Method of measurement
file
10
Description
Frequency of using anti emetic drug
Timepoint
24 hours after entering recovery
Method of measurement
file
11
Description
Extubation time
Timepoint
After Extubation
Method of measurement
Clock
12
Description
Length of stay in recovery
Timepoint
After exiting recovery
Method of measurement
Clock
13
Description
Patient satisfaction score
Timepoint
24 hours after entering recovery
Method of measurement
Likert scale
14
Description
Beginning time of using liquid foods
Timepoint
after using liquid foods
Method of measurement
Clock
15
Description
Beginning time of using solid foods
Timepoint
after using solid foods
Method of measurement
Clock
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After receiving 5 ml / kg of ringer lactate and pre-oxygenation for patients, the same anesthetic induction was performed including Fentanyl 2mcg / kg, Propofol 2 mg / kg and Atracurium 0.6mg / kg, and the patients underwent mechanical ventilation by mask for three minutes. Immediately before intubation, 1 cc of dexamethasone was injected in each nostril.
Category
Prevention
2
Description
Control group: After receiving 5 ml / kg of ringer lactate and pre-oxygenation for patients, the same anesthetic induction was performed including Fentanyl 2mcg / kg, Propofol 2 mg / kg and Atracurium 0.6mg / kg, and the patients underwent mechanical ventilation by mask for three minutes. Immediately before intubation, 1 cc of normal saline was injected in each nostril.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Modares st.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2034
Email
hamidshetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaqayeq Haghjooye Javamard
Street address
Vice chacellor of research and technology of university isfahan, University of medical sciences, Hezarjerib st.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 8134
Email
vcr-office@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz Hospital ،Modares st.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2034
Email
hamidshetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz Hospital ،Modares st.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2034
Email
hamidshetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Feyz Hospital ،Modares st.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3445 2034
Email
hamidshetabi@med.mui.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
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