Comparison of the effect of nasal dexamethasone on post hysterectomy surgery nausea and vomiting prevention in adults
Design
Clinical trials in two community-based and pragmatic groups with parallel blinded, randomized, 35-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 hysterectomy surgery in Shahid Beheshti Hospital and Alzahra Hospital, the patient and researcher are unaware of which drug is used for each patient
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women older than 18 years;
American society of anesthesiologists(ASA) physical status classification 1 or 2 ; Filled informed consent form ;
Hysterectomy under general anesthesia ;
Exclusion criteria:
Patient with sever and uncontroled cardiovascular , renal , liver and chronic lung diseases ;
Systemic fungal infection ;
Contraindication for dexamethasone ;
Taking antiemetic and analgesics drugs during last 24 hours before surgery ;
Pregnant women ;
Menstural period ;
Patients with motion sickness and GI problems and history of postoperative nausea and vomiting ;
Patients with History of Psycologic Problem and Parkinson Disease ;
History of Chemotherapy .
Intervention groups
Recipient of Dexamethasone (A) and Saline (B)
Main outcome variables
Incidence of nausea ; Score of nausea ; Incidence of vomiting ; Score of vomiting ; Score of pain ; First time using anti emetic drug ; Total dose of anti emetic ; Frequency of using anti emetic drug ; Extubation time ; Length of stay in recovery ; Patient satisfaction score ; Beginning time of using liquid foods ; Beginning time of using solid foods ; age ; Under treatment group ; Length of stay in hospital
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039326N13
Registration date:2020-06-15, 1399/03/26
Registration timing:registered_while_recruiting
Last update:2020-06-15, 1399/03/26
Update count:0
Registration date
2020-06-15, 1399/03/26
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
2020-06-14, 1399/03/25
Expected recruitment end date
2021-06-15, 1400/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of intranasal dexamethasone on prevention of postoperative nausea and vomiting in hysterectomy
Public title
Effect of intranasal dexamethasone on prevention of postoperative nausea and vomiting in hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women older than 18 years
American society of anesthesiologists(ASA) physical status classification 1 or 2
Filled informed consent form
Hysterectomy under general anesthesia
Exclusion criteria:
Patient with sever and uncontroled cardiovascular ، renal ، liver and chronic lung diseases
Systemic fungal infection
Contraindication for dexamethasone
Taking antiemetic and analgesics drugs during last 24 hours before surgery
Pregnant women
Menstural period
Patients with motion sickness and GI problems and history of postoperative nausea and vomiting
Patients with History of psycologic problem and Parkinson disease
History of chemotherapy
Age
From 18 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation to intervention and control groups using Random allocation software.70 patients who have candidated for elective hysterectomy will divided randomly to intervention group who will recieve nasal dexamethasone (group A) and control group who will recieve nasal normal saline.
Blinding (investigator's opinion)
Double blinded
Blinding description
Anesthesiologist who has no function in collection of dates devides drugs in two groups A and B with same volume and then describes them . In this double-blind clinical trial the patient and the observer who records dates are unware of patients groups and drugs which are being studied but the analyzer is aware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Hezar Jerib St
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.MUI.MED.REC.1398.731
Health conditions studied
1
Description of health condition studied
Postoperative Nausea and Vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and Vomiting
Primary outcomes
1
Description
Incidence of nausea
Timepoint
At recovery (every 10min or having symptom) and 2 and 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Score of nausea
Timepoint
At recovery (every 10min or having symptom) and 2 and 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
3
Description
Incidence of vomiting
Timepoint
At recovery (every 10min or having symptom) and 2 and 12 and 24 hours after surgery
Method of measurement
scoring system for vomiting
4
Description
Score of vomiting
Timepoint
At recovery (every 10min or having symptom) and 2 and 12 and 24 hours after surgery
Method of measurement
Scoring system for vomiting
5
Description
Score of pain
Timepoint
At recovery (every 10min or having symptom) and 2 and 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale
6
Description
First time using anti emetic drug
Timepoint
24 hours after entering recovery
Method of measurement
minute
7
Description
Total dose of anti emetic
Timepoint
24 hours after entering recovery
Method of measurement
file
8
Description
Frequency of using anti emetic drug
Timepoint
24 hours after entering recovery
Method of measurement
file
9
Description
Extubation time
Timepoint
After Extubation
Method of measurement
minute
10
Description
Length of stay in recovery
Timepoint
After exiting recovery
Method of measurement
minute
11
Description
Patient satisfaction score
Timepoint
24 hours after entering recovery
Method of measurement
Likert scale
12
Description
Beginning time of using liquid foods
Timepoint
after using liquid foods
Method of measurement
minute
13
Description
Beginning time of using solid foods
Timepoint
after using solid foods
Method of measurement
minute
14
Description
Length of stay in hospital
Timepoint
After exiting hospital
Method of measurement
day
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After receiving 10ml/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 0.5 to 0.7 mg / kg, midazolam 0.3 to 0.5mcg / kg and the patients underwent mechanical ventilation by mask and ambobag for three minutes. Immediately after intubation, 1 cc of dexamethasone (4mg) was injected in each nostril.
Category
Prevention
2
Description
Control group: After receiving 10ml/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 0.5to 0.7mg / kg, midazolam 0.3to 0.5mcg / kg and the patients underwent mechanical ventilation by mask and ambobag for three minutes. Immediately after intubation, 1 ml of normal saline was injected in each nostril.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Shahid Beheshti Hospital , Motahari St
City
Esfahan
Province
Isfehan
Postal code
8184853543
Phone
+98 31 3236 7001
Email
hamidshetabi@med.mui.ac.ir
2
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Al-Zahra Therapeutic Training Center, Sofeh Boulevard
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1818
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 Javanmard
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?
No
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
Al-Zahra Therapeutic Training Center, Sofeh Boulevard
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1818
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
Al-Zahra Therapeutic Training Center, Sofeh Boulevard
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1818
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
Al-Zahra Therapeutic Training Center, Safeh Boulevard
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1818
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