Effects of dexmedetomidine on Postoperative Shivering and nausea and vomiting in Patients With Opium Addiction After Elective supratentorial Brain tumor Surgeries.
Determining the effect of dexmedetomidine on postoperative shivering, nausea and vomiting in addicted patients.
Design
100 opium addicted patients that are candidated for supratentorial brain tumor surgery and have inclusion criteria will be selected and divided into two groups of control and intervention with block randomized and computer generated randomizid. This study is double blind.
Settings and conduct
Patients with inclusion criteria will be selected in Shohada Tajrish Hospital and after taking consent form and due to dividing to the control and intervention group, placebo and drug will be administered and outcome of them will be recorded in the recovery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: opium addicted; afebrile; without nausea and vomiting before surgery
Exclusive criteria: fever; not addiction; history of postoperative nausea and vomiting; history of GI disease
Intervention groups
control group: receiving placebo(Normal Saline)
Intervention group: receiving dexmedetomidine
Main outcome variables
evaluation of postoperative shivering, nausea and vomiting in two group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201122049464N1
Registration date:2020-12-22, 1399/10/02
Registration timing:registered_while_recruiting
Last update:2020-12-22, 1399/10/02
Update count:0
Registration date
2020-12-22, 1399/10/02
Registrant information
Name
Mona Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 7554
Email address
monarajabi1989@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-17, 1399/09/27
Expected recruitment end date
2021-01-16, 1399/10/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of dexmedetomidine on Postoperative Shivering and nausea and vomiting in Patients With Opium Addiction After Elective supratentorial Brain tumor Surgeries.
Public title
Effects of dexmedetomidine on Postoperative Shivering and nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
opium addicted
with supratentorial Brain
afebrile (normotherm)
Exclusion criteria:
not opium addicted
febrile
with cardiac arrhythmia
with history of post operation nausea and vomiting
with history of motion sickness
with history of GI disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
100 opium addicted patients that are candidated for supratentorial brain tumor surgery who have enrollment criteria will be selected. After that we will randomize the patients using a computer-based program with random number generator protocol in two groups of 50 patients ( intervention: dexmedetomidine user and control group: placebo user).The site www.calculator.net will be used for this division.According to the instructions of this site, the lower limit of 1 and the upper limit of 100 will be used and according to the software calculations, the numbers will be given to the patients randomly and the numbers 1-50 and the numbers 51-100 will be in the control group or in the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient who is not responsible for distributing drug, data collecting and analyzing will divide drug and placebo in tho the boxes without name and will code them by A&B. After that this boxes will be administered to the patients by researcher and trained staff and collected data will be delivered to the analyzer. Also the patients will know about this research and will read consent form but they will not know which groups they are in.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Science
Street address
No.2, Arabi Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.SBMU.MSP.REC.1398.126
Health conditions studied
1
Description of health condition studied
postoperative shivering , nausea and vomiting
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Effect of dexmedetomidine on postoperative shivering , nausea and vomiting.
Timepoint
Upon arrival to the recovery room till minute 150.
Method of measurement
n order to assess research variables such as nausea and vomiting, observation method was applied by the anesthesiologist and a trained nurse during post-operative recovery. Moreover, the Bedside Shivering Assessment Scale (BSAS) was applied to evaluate shivering at the bedside where shivering grades were 2 and 3.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group are the patients who are opium addicted and candidated for supratentaria brain tumor surgery that will be revived drug.( infusion of dexmedetomidine 1 mag/kg/min in 10 minutes and 30 minutes before induction.)
Category
Treatment - Drugs
2
Description
Control group: This group are the patients who are opium addicted and candidated for supratentorial brain tumor surgery that will be received placebo ( infusion of normal salin in 10 minutes and 30 minutes before induction)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Reza Jalili Khoshnood
Street address
Tajrish squ
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 9014
Email
pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No. 2 , Arabi Ave.,
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mona Rajabi
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 6, Banafshe dead end., Sizdah Chenar Ave., Daneshjoo squ
City
Tehran
Province
Tehran
Postal code
5335054403
Phone
009822427554
Email
monarajabi1989@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mona Rajabi
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 6, Banafshe dead end., Sizdah Chenar Ave., Daneshjoo Squ
City
Tehran
Province
Tehran
Postal code
5335054403
Phone
009821224278554
Email
monarajabi1989@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mona Rajabi
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No. 6, Banafshe dead end., Sizdah Chenar Ave., Daneshjoo Squ
City
Tehran
Province
Tehran
Postal code
5335054403
Phone
+98 21 2242 7554
Email
monarajabi1989@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