Protocol summary

Study aim
The results of this study may contribute to reducing postoperative complications and hospital costs in children undergoing laparoscopic surger
Design
This study is a randomized, triple-blind, controlled clinical trial.Participants will be randomly assigned to one of the study groups using the Random Allocation software. The random allocation to groups will be carried out by a nurse who is not involved in the study. It is worth mentioning that the injection syringes in both groups are identical in shape and brand, and are labeled with letters A and B to ensure blinding.
Settings and conduct
The patient, physician, and the data analyst are blinded to the group assignments. This study will be conducted at Imam Hossein Hospital in Isfahan. Patients will be divided into two groups those receiving dexamethasone and those receiving normal saline. The primary outcome will be the occurrence of PONV within the first 24 hours after surgery
Participants/Inclusion and exclusion criteria
Inclusion Criteria 1. Age range between 2 to 15 years. 2. Candidates for laparoscopic herniorrhaphy or varicocelectomy (type of surgery should be limited; gastrointestinal surgeries are excluded). 3. Informed consent from the parents of the patient to participate in the study. 4. ASA classification I & II Non-Inclusion Criteria 1. Patients with motion sickness. 2. Patients with a history of nausea and vomiting post-surger 3. Nasal mucosal disorders such as allergies and polyps 4. Patients who received anti-nausea medications
Intervention groups
In the intervention group, children will receive dexamethasone at a dose of 0.15 mg/kg after the induction of anesthesia, while the control group will receive a normal saline solution at the same dose
Main outcome variables
Reducing the incidence of nausea and vomiting in children undergoing laparoscopic surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180416039326N24
Registration date: 2024-08-24, 1403/06/03
Registration timing: prospective

Last update: 2024-08-24, 1403/06/03
Update count: 0
Registration date
2024-08-24, 1403/06/03
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
2024-09-15, 1403/06/25
Expected recruitment end date
2025-02-13, 1403/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the preventive effect of intranasal dexamethasone in reducing nausea and vomiting after laparoscopic surgery in children
Public title
Investigating the preventive effect of intranasal dexamethasone in reducing nausea and vomiting after laparoscopic surgery in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion Criteria for the Study:1. Age range between 2 to 15 years2. Candidates for laparoscopic herniorrhaphy and varicocele surgery (the type of surgery must be limited to these cases, and GI surgeries should be excluded)3. Informed consent from the patient's parents for participation in the study4. ASA classification I and II
Exclusion criteria:
Exclusion Criteria:1. Change in surgical method or anesthesia technique2. Requirement to keep the nasogastric tube in place after surgery3. Surgery duration exceeding two hours Exclusion Criteria [considering nasal mucosal disorders such as allergies and polyps]:**1. Patients with motion sickness2. Patients with a history of nausea and vomiting after surgery3. Nasal mucosal disorders such as allergies and polyps4. Patients who have received anti-nausea medications such as phenothiazines, scopolamine, corticosteroids, and tricyclic antidepressants within 24 hours prior to the surgery
Age
From 2 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
This clinical trial study will be conducted after obtaining the necessary permits and ethical code, and it will assess the effect of dexamethasone on reducing nausea and vomiting after surgery in children undergoing laparoscopic procedures. These patients will be kept NPO (nothing by mouth) for 6 to 8 hours before entering the operating room. They will be randomly assigned to one of the study groups using the Random Allocation software. The random allocation to groups will be carried out by a nurse who is not involved in the study. In the intervention group, children will receive dexamethasone at a dose of 0.15 mg/kg after the induction of anesthesia, while the control group will receive normal saline at the same dose. It is worth noting that the syringes used in both groups will be identical in shape and brand, marked with letters A and B to ensure blinding. The codes will not be revealed until after data analysis. The patient, evaluating physician, and data analyst will be blinded and unaware of group assignments. After the children enter the operating room, their demographic data, such as age, gender, and ASA score, will be recorded through a checklist.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This clinical trial study will be conducted after obtaining the necessary permits and ethical code, and it will assess the effect of dexamethasone on reducing nausea and vomiting after surgery in children undergoing laparoscopic procedures. These patients will be kept NPO (nothing by mouth) for 6 to 8 hours before entering the operating room. They will be randomly assigned to one of the study groups using the Random Allocation software. The random allocation to groups will be carried out by a nurse who is not involved in the study. In the intervention group, children will receive dexamethasone at a dose of 0.15 mg/kg after the induction of anesthesia, while the control group will receive normal saline at the same dose. It is worth noting that the syringes used in both groups will be identical in shape and brand, marked with letters A and B to ensure blinding. The codes will not be revealed until after data analysis. The patient, evaluating physician, and data analyst will be blinded and unaware of group assignments. After the children enter the operating room, their demographic data, such as age, gender, and ASA score, will be recorded through a checklist. This study is a randomized, triple-blind, controlled clinical trial.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Isfahan University of Medical Sciences
Street address
Anesthesia Department, al_zahra hospital, hezar jarib street, isfahan
City
Isfahan
Province
Isfehan
Postal code
9861643175
Approval date
2024-07-10, 1403/04/20
Ethics committee reference number
IR.MUI.MED.REC.1403.144

Health conditions studied

1

Description of health condition studied
The preventive effect of intranasal dexamethasone on reducing postoperative nausea and vomiting after laparoscopic surgery in children.
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
The primary consequence of the occurrence of PONV (Postoperative Nausea and Vomiting) will be within the first 24 hours after surgery.
Timepoint
The level of nausea will be assessed during the time spent in recovery, as well as when the patient is in the treatment units. The frequency of assessment will follow a pattern of every 15 minutes in the recovery unit and every four hours for the first 24 hours post-surgery.
Method of measurement
The data obtained from this study will be analyzed using SPSS v28 and will be examined for descriptive statistics. Quantitative data will be reported with mean and standard deviation, while qualitative data will be reported with frequency and percentage. Additionally, to assess the significance of the impact on reducing nausea and vomiting, independent t-tests (for comparing continuous quantitative variables between two groups), Mann-Whitney tests (for comparing discrete quantitative variables between two groups), and chi-square tests (for comparing qualitative variables between two groups) will be employed.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention:children receive dexamethasone at a dose of 0.15 mg/kg after the induction of anesthesia.
Category
Prevention

2

Description
Control group: Patients in the control group will receive normal saline at a dose of 0.15 mg/kg.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam hossein hospital
Full name of responsible person
Hamid reza shetabi
Street address
Anesthesia Department, al_zahra hospital, hezar jarib street, Isfahan
City
Isfehan
Province
Isfehan
Postal code
9861643175
Phone
+98 31 3620 1992
Email
Alibameri405@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza askari
Street address
Anesthesia Department, al_zahra hospital, hezar jarib street, Isfahan
City
Isfehan
Province
Isfehan
Postal code
9861643175
Phone
+98 903 896 3492
Email
Alibameri405@gmail.com
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
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres st.feiz hospital
City
Isfahan
Province
Isfehan
Postal code
9861643175
Phone
+98 31 3620 2020
Fax
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
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres st.feiz hospital
City
Isfahan
Province
Isfehan
Postal code
9861643175
Phone
+98 31 3620 2020
Fax
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
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres st.feiz hospital
City
Isfahan
Province
Isfehan
Postal code
9861643175
Phone
+98 31 3620 2020
Fax
Email
Hamidshetabi@med.mui.ac.ir

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
There is no additional information available.
Study Protocol
Yes - There is 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
Title and more details about the data/document
This clinical trial study will be conducted after obtaining the necessary permits and ethical code, and it will assess the effect of dexamethasone on reducing nausea and vomiting after surgery in children undergoing laparoscopic procedures. These patients will be kept NPO (nothing by mouth) for 6 to 8 hours before entering the operating room. They will be randomly assigned to one of the study groups using the Random Allocation software. The random allocation to groups will be carried out by a nurse who is not involved in the study. In the intervention group, children will receive dexamethasone at a dose of 0.15 mg/kg after the induction of anesthesia, while the control group will receive normal saline at the same dose. It is worth noting that the syringes used in both groups will be identical in shape and brand, marked with letters A and B to ensure blinding. The codes will not be revealed until after data analysis. The patient, evaluating physician, and data analyst will be blinded and unaware of group assignments. After the children enter the operating room, their demographic data, such as age, gender, and ASA score, will be recorded through a checklist.
When the data will become available and for how long
Data collection will begin on September 16, 2024, and will conclude on March 15, 2025. After this date, the results will be accessible.
To whom data/document is available
This study will be accessible to both people in academic and scientific institutions and people in industry
Under which criteria data/document could be used
In order to use the data in studies and other works, it is necessary to coordinate with the person in charge of the research And only reading is free for the public
From where data/document is obtainable
Coordination with the research officer, Dr. Hamidreza Shatabi, or the research affairs of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Coordination with the research officer, Dr. Hamidreza Shatabi, or the research affairs of Isfahan University of Medical Sciences(email,phone and…)
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