Evaluation of the effect of intravenous diphenhydramine injection before anesthesia induction on postoperative pain , nausea and vomiting reduction in bariatric laparoscopic surgery
Determining the effect of intravenous diphenhydramine on pain reduction after bariatric surgery in recovery and ward
Design
A double-blind randomized clinical trial with control group, and parallel groups, phase 3-2 on 38 patients. Excel software was used to randomize.
Settings and conduct
A double blind clinical trial study in obese patients with a body mass index greater than 40 was performed at Sinai Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All obese patients are candidates for bariatric surgery aged 20-55 years
Exclusion criteria: history of large prostate disease, glaucoma, uncontrolled blood pressure
Intervention groups
Intervention group: 0.5 mg/kg of diphenhydramine is injected intravenously before anesthesia induction and the degree of agitation, pain, and hemodynamic changes during extubation, and the incidence of nausea and vomiting in the recovery and the total amount of analgesic requirement are evaluated during 24 hours after surgery.
Control group: They do not receive medication and the degree of agitation, pain, and hemodynamic changes during extubation, and the incidence of nausea and vomiting in the recovery and the total amount of analgesic requirement are evaluated during 24 hours after surgery.
Main outcome variables
The incidence of pain, agitation, nausea, and vomiting after bariatric surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130304012695N6
Registration date:2020-07-10, 1399/04/20
Registration timing:retrospective
Last update:2020-07-10, 1399/04/20
Update count:0
Registration date
2020-07-10, 1399/04/20
Registrant information
Name
mohammadreza khajavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6312 1220
Email address
khajavim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-14, 1398/01/25
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
2019-04-09, 1398/01/20
Actual recruitment end date
2020-07-02, 1399/04/12
Trial completion date
2020-07-05, 1399/04/15
Scientific title
Evaluation of the effect of intravenous diphenhydramine injection before anesthesia induction on postoperative pain , nausea and vomiting reduction in bariatric laparoscopic surgery
Public title
Reduction of nausea ,vomiting and pain of bariatric surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Body mass index grater than 40
Exclusion criteria:
History of large prostate disease
Glucome
Drug addiction
uncontrolled hyperthension
Age
From 20 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
38
Actual sample size reached:
38
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize patients with inclusion criteria
Block balanced randomization is used.Before studying, one of the person who is not a member of the research team performs the randomization process by using Random generator software, forms four blocks for the intervention and control group.
The complete cards of the four blocks are given to the head of the operating room, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to operating room.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants:Since patients are not aware of the type of study drug at the time of anesthesia induction they were blind about the group to which they were allocated.
Those who evaluate the outcome:The assistant who records the results in this study does not know the type of group
Data collection officials:The person who analyzes the data also does not know the type of participating groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of school of medicine, Tehran university of medical sciecences
Street address
Sina hospital,Hasan Abad Sq-Emam khomeni st.
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2019-03-04, 1397/12/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.958
Health conditions studied
1
Description of health condition studied
Abdominal Acute Pain after laparoscopic bariatric surgery
ICD-10 code
R10.0
ICD-10 code description
Acute abdomen
2
Description of health condition studied
Postoperative nausea and vomiting
ICD-10 code
K 91.0
ICD-10 code description
Vomiting following gastrointestinal surgery
Primary outcomes
1
Description
Incidence and severity of abdominal pain
Timepoint
During extubation and 5, 15, 30 and 60 minutes after surgery
Method of measurement
Visual Analogue Scale
2
Description
Severity of postoperative agitation
Timepoint
During extubation and 5, 15, 30 and 60 minutes after surgery
Method of measurement
Ramsy sedation Scale
3
Description
Incidence of nausea and vomiting
Timepoint
In recovery room and ward
Method of measurement
The number of nausea and vomiting
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.5 mg/kg of diphenhydramine is injected intravenously before anesthesia and the degree of agitation, pain, and hemodynamic changes during extubation, and the incidence and severity of abdominal pain and nausea and vomiting in the recovery and the total amount of analgesic requirement are evaluated during 24 hours after surgery.
Category
Prevention
2
Description
Control group: They do not receive medication and the degree of agitation, pain, and hemodynamic changes during extubation, and the incidence and severity of abdominal pain and nausea and vomiting in the recovery and the total amount of analgesic requirement are evaluated during 24 hours after surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mohammad Reza Khajavi
Street address
Sina Hospital Imam khomeini st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8550
Email
khajavim@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
Keshavarz Blvd., corner of Quds St., Central Organizatioehran University of Medical Sciences of Tehran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
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
Mohammad Reza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Imam Khomeini
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1220
Fax
+98 21 6312 0000
Email
khajavim@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Imam Khomeni st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 8550
Email
khajavim@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Khajavi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital Imam Khomeini st
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1220
Email
khajavim@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this 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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All information used for this research can be shared after unidentified the identity of patients. Also, statistical information, information analysis, study method, findings and conclusions can be shared.
When the data will become available and for how long
Starting access after accepting by a valid scientific journal and publishing it
To whom data/document is available
For academic researchers and in the field of science
Under which criteria data/document could be used
All researchers can use all published material and if all or part of this research is published by other people, the name and source of this research and its researchers should be mentioned.
From where data/document is obtainable
Mohammad Reza Khajavi
What processes are involved for a request to access data/document
The applicant can request the type of files by email.
khajavim@tums.ac.ir