Protocol summary

Study aim
The prophylactic effect of intravenous injection of Dexmedetomidine، Ondansetrone، Pethidine on tremor after abdominal surgery under the general anesthesia and comparisone with control group
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
In a double blind clinical trial study in Alzahra and Kashani teaching hospitals in Isfahan, 128 patients undergoing abdominal surgery were divided into four groups of 32 patients and groups respectively of 0.5. Micrograms / kg dexmedetomidine, 0.5mg / kg pethidine, 0.1. Mg / kg ondansetron and normal saline were injected intravenously at the time of anesthesia and the incidence and severity of postoperative shivering were determined and compared in four groups. The method of blinding was that patients were unaware of the type of drug being administered, and the medication was prepared by one of the operating room staff who was not in the study, in similar, coded syringes, and was given expert advice on injection. .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Male and female ASAI-II candidates for abdominal surgery under general anesthesia in the age range of 18 to 60 years. Exclusion: TCA.MAOI, vasoactive, pain medication history, Opioid, Nerve and Muscle Disease, Thyroid Disease, Dys autonomic, Fever, A history of cardiovascular, respiratory, endocrine Or neurological, BMI>27 , obesity, pregnancy , hypersensitivity to magnesium sulfate, ketamine and pethidine drugs.
Intervention groups
128 patients who met the inclusion criteria were enrolled They were studied and randomly assigned to one of these four groups, respectively Will take. In group D, 0.5 µg / kg dexmedetomidine - in group P 0.5 mg / kg pethidine - in group O, one tenth mg / kg ondansetron - in group N, distilled water is also volumeized in similar syringes.
Main outcome variables
Prevention of shivering after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190708044155N1
Registration date: 2019-08-25, 1398/06/03
Registration timing: registered_while_recruiting

Last update: 2019-08-25, 1398/06/03
Update count: 0
Registration date
2019-08-25, 1398/06/03
Registrant information
Name
Mahsa Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3258 0119
Email address
mahsaheydari.mahsa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-30, 1398/04/09
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prophylactic effect of intravenous injection of Dexmedetomidine، Ondansetrone، Pethidine on tremor after abdominal surgery under the general anesthesia and comparisone with control group
Public title
The effect of Dexmedetomidine، Ondansetrone، Pethidine on tremor after abdominal surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women with ASA 1 and 2 Candidate for abdominal surgery under general anesthesia 18 to 60 years old
Exclusion criteria:
History of Vasoactive Drugs, Opioids, TCA, MAOI Nerve and muscle disease Thyroid disease Fever Pregnancy Obesity BMI> 27 Cardiovascular, Respiratory, Endocrine, Neurological diseases Sensitivity to Pethidine, Ondansetrone, Ketamine
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomaly assigned to intervention and control groups with using the Random Allocation computer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs and placebo are prepared in one form and in the form of a volume in the syringe by the researcher and the hemodynamic changes created are monitored and recorded. Therefore, the participant and the clinical caregiver and evaluatorl and data analyser analyst do not understand the type of drug and after analyzing the codes by the researcher Decoded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
81774673461
Approval date
2019-06-30, 1398/04/09
Ethics committee reference number
IR.MUI.MED.REC.1398.182

Health conditions studied

1

Description of health condition studied
Teremor rate after surgery
ICD-10 code
R25.1
ICD-10 code description
Tremor, unspecified

Primary outcomes

1

Description
Tremor rate after surgery
Timepoint
For the first 15 minutes continuously and then every 15 minutes to 1 hour
Method of measurement
Crassly and Mahajan

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: In group D 0.5mg / kg dexmedetomidine - injected intravenously 1 time after the last wound is closed
Category
Prevention

2

Description
Intervention group 2: In group P 0.5mg / kg pethidine - injected intravenously 1 time after the last wound is closed
Category
Prevention

3

Description
Intervention group 3 in group O One tenth mg / kg ondansetron -injected intravenously 1 time after the last wound is closed
Category
Prevention

4

Description
In control group 1: In group N distilled water in syringe Similar volumes are also generated. All cases are volumeized 1 time and are injected intravenously 1 time after the last wound is closed
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Behzad Nazemroaya
Street address
Hizar jirib street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mahsaheydari.mahsa@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Hizar jirib street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 2020
Email
mahsaheydari.mahsa@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
Mahsa Heydari
Position
Student of medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Shahid Keshvari Highway - Sofia Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mahsaheydari.mahsa@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahsa Heydari
Position
Student of medicine
Latest degree
Medical doctor
Other areas of specialty/work
Public Health
Street address
Shahid Keshvari Highway - Sofia Boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
mahsaheydari.mahsa@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Heydari Mahsa
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Hezar Jarib Street - Hostel Collection
City
Isfahan
Province
Isfehan
Postal code
81774673461
Phone
00983830119
Email
mahsaheydari.mahsa@gmail.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
Information about the main outcome is published.
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For information on continuing research
From where data/document is obtainable
mahsaheydari.mahsa@gmail.com 00989370272404 Mahsa Heidari-Isfahan University of Medical Sciences behzad_nazem@md.mui.ac.ir 00989162907797 Dr. Behzad Nazem Raaya-Al-Zahra Hospital
What processes are involved for a request to access data/document
Email your request.
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