Protocol summary

Study aim
If we find the most effective drug in reducing the post operative nausea and vomiting the patient satisfaction will increase and the expenditure of medical center will decrease.
Design
Clinical trial with control group, with parallel group, three way blind, on 165 patient, random allocating software for randomization
Settings and conduct
The patients referring Alzahra and Ayatollah Kashani hospitals in Esfahan who are candidate for elective middle ear surgery, after obtaining informed consent are divided into three groups, under general anesthesia and intubation, receive drug according to their group, measuring of the severity of the nausea and vomiting in the recovery with visual analog scale (VAS).
Participants/Inclusion and exclusion criteria
Entry condition: the patient between the age 18 to 65 years old who consciously participate in study. Exit condition: liver or heart or kidney failure; death of patient; sensitivity to drugs in study; BMI more than 30.
Intervention groups
After general anesthesia with fentanyl, lidocaine, thiopental and intubation and 15 to 20 minute before making a surgical incision, depending on which of the group O, P, D the patient belongs to receive drug or placebo. group O: 0/1 milligram per kilogram ondansetron; group D: dexmedetomidin 1 microgram per kilogram per minute; group p: 10 cc normal saline in 10 minutes.
Main outcome variables
Mean severity of post operative nausea; frequency of post operative vomiting; the average dose of antiemetic used; the average of first time; antiemetic needed; the first time that the fluid diet tolerated; the average time took to tolerate solid diet; mean patient satisfaction score; duration of anesthesia of patient; duration of surgery of patient; average length of stay in recovery; average of pain intensity; average time of extubation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101211005362N27
Registration date: 2022-01-22, 1400/11/02
Registration timing: registered_while_recruiting

Last update: 2022-01-22, 1400/11/02
Update count: 0
Registration date
2022-01-22, 1400/11/02
Registrant information
Name
Mohammadreza Safavi
Name of organization / entity
Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1273 2659
Email address
safavi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the preemptive Dexmedetomidine with Ondansetron effect in reducing the post-operative nausea and vomiting after elective middle ear surgery under general anesthesia
Public title
The effect of ondansetron and dexmedetomidine in reducing nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
People who willingly want to participate in the study ASA class 1,2 People between the ages of 18 and 65 y/o No motion sickness or Parkinson's disease
Exclusion criteria:
Heart, liver, kidney failure Previous sensitivity to the drugs used in the study Obese patients (BMI more than 30) Patients with mental retardation Patients who have taken antiemetic before operation. Any change in anesthesia Patient death during surgery Surgeries that cause severe nausea and vomiting, such as surgery on the labyrinth (otosclerosis, cholesteatoma with fistula, etc.)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 165
Randomization (investigator's opinion)
Randomized
Randomization description
165 people are selected by easy random method. The way to randomize is that anesthesiologist from a dark-colored bag containing 165 cards with titles O ( Ondansetron), D ( Dexmedetomidine), P ( placebo) that there are 55 of each card, and according to the card that is picked up the patient enters the investigation. (Output card will not be replaced).
Blinding (investigator's opinion)
Triple blinded
Blinding description
Drug injections are performed by an anesthesiologist without knowing the contents of the syringes. (Also, all syringes have the same color and volume). The way to randomize is that anesthesiologist from a dark-colored bag containing 165 cards with titles O ( ondansetron), D ( dexmedetomidine), P ( placebo) that there are 55 of each card, and according to the card that is picked up The patient enters the investigation.(Output card will not be replaced). Patients also do not know about the medication they are receiving.
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
Heza Jjarib street, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.MUI.MED.REC.1400.501

Health conditions studied

1

Description of health condition studied
Post operative nausea and vomiting
ICD-10 code
R11.0
ICD-10 code description
Nausea after surgery; Postoperative nausea; Nausea NOS; Nausea without vomiting

Primary outcomes

1

Description
Mean severity of post operative nausea
Timepoint
Every 15 minutes for 1 hour and then every 6 hours for 24 hours
Method of measurement
Visual analog scale

2

Description
Frequency of post operative vomiting
Timepoint
Every 15 minutes for 1 hour and then every 6 hours for 24 hours
Method of measurement
According to percentage

3

Description
The average dose of antiemetic used
Timepoint
In the recovery and the first 24 hours after surgery
Method of measurement
Dose of drug used

4

Description
The average of first time, antiemetic needed
Timepoint
In the recovery and the first 24 hours after surgery
Method of measurement
Time that drug used

5

Description
The first time that the fluid diet tolerated
Timepoint
The first 24 hours after surgery
Method of measurement
Time the diet tolerated

6

Description
The average time took to tolerate solid diet
Timepoint
The first 48 hours after surgery
Method of measurement
Time the diet tolerated

7

Description
Mean patient satisfaction score
Timepoint
The first 24 hours after surgery
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
Duration of anesthesia of patient
Timepoint
During the operation and 24 hour after that
Method of measurement
Minute

2

Description
Duration of surgery of patient
Timepoint
During the operation
Method of measurement
Minute

3

Description
Average length of stay in recovery
Timepoint
During the presence in recovery
Method of measurement
Modified aldrete score

4

Description
Average of pain intensity
Timepoint
The first 24 hour after surgery
Method of measurement
visual analog scale

5

Description
Average time of extubation
Timepoint
After surgery
Method of measurement
Minute

Intervention groups

1

Description
Intervention group: they receive 0/1 mg per kg ondansetron in 10 cc normal saline in 10 minute
Category
Prevention

2

Description
Control group: 10 cc normal saline in 10 minute
Category
Placebo

3

Description
Intervention group: they recieve 1 microgram per kilogram in 10 cc normal saline in 10 minute
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Seyed Mohammad Reza Safavi Hommami
Street address
Shahid Keshvari Highway, Soufe Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir

2

Recruitment center
Name of recruitment center
Ayatollah kashani hospital
Full name of responsible person
Seyed Mohammad Reza Safavi Hommami
Street address
Kashani Street, between Taleghani Street and Mirdamad Street.
City
Isfhan
Province
Isfehan
Postal code
81839-83434
Phone
+98 31 3233 0091
Email
kashani@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mansour Siavash
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
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
Seyed Mohammadreza Safavi Homami
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra hospital, Sofe Boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
safavi@med.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Mohammadreza Safavi Homami
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra hospital, Sofe Boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
safavi@med.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Negar Maleki
Position
medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Alzahra hospital, Sofe Boulevard, Shahid Keshvari highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
negarmaleky569@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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