The effects of Dexmedetomidine compared with Meperidine on the prevention of postoperative shivering in patients after cesarean section with spinal anesthesia.
Determination and comparison of the effect of Dexmedetomidine with Meperidine in the prevention of postoperative seizures in patients undergoing cesarean section with spinal anesthesia
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 150 patients. For randomization, a randomized block with random samples is used in ten 15-block blocks. In each block, five cards are placed for each group. Then a card is selected from inside the first block. And for the next patient, a card is selected from the same block. By performing each block, five patients were chosen for each group.
Settings and conduct
This study will be done in the field of postoperative seizure prevention in patients undergoing cesarean section with spinal anesthesia at Ali Ibn Abitaleb Hospital in Zahedan. It will be double-blinded. Patients will not be aware of the drug used. An anesthesiologist will prepare the medicine, Who has no role in evaluating the patient. Then it will be delivered to the anesthesiologist. Evaluating nurses won't aware of drug type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All pregnant women between the ages of 18 and 45 who have had a cesarean section using spinal anesthesia and are physically classified in I and II classes of the American Society of Anesthesiologists. Exclusion criteria: History of allergy to the drugs studied, Addiction, Taking Alpha-antagonist drugs, Altered thyroid function, Coronary artery insufficiency and high blood pressure, Asthma and Respiratory failure, Liver or kidney failure, History of seizures.
Intervention groups
Dexmedetomidine group
Meperidine group
Placebo group
Main outcome variables
Postoperative shivering
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190603043799N1
Registration date:2020-08-03, 1399/05/13
Registration timing:prospective
Last update:2020-08-03, 1399/05/13
Update count:0
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Sufia Ahrari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3322 7108
Email address
sa_ahrari186@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Dexmedetomidine compared with Meperidine on the prevention of postoperative shivering in patients after cesarean section with spinal anesthesia.
Public title
The effects of Dexmedetomidine compared with Meperidine on the prevention of postoperative shivering.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All pregnant women are 18 to 45 years old
Perform cesarean section using spinal anesthesia
Physically, they are in the first and second class of the American Society of Anesthesiologists
Exclusion criteria:
History of allergy to the drugs studied
Addiction
Taking Alpha-antagonist drugs
Altered thyroid function
Coronary artery insufficiency and high blood pressure
Asthma and Respiratory failure
Liver or kidney failure
History of seizures
History of nausea and vomiting in a previous surgery
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks containing three random digits cards, each of which represents three groups, will be prepared and placed in ten blocks of 15 using the random method blocked by the sample. Then, the participants that have the conditions for entering the study are selected from one of the blocks, respectively, from one side of the card block, and according to it, they are in one of the three groups receiving Dexmedetomidine and Meperidine (test group) and Control (placebo).
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients won't be aware of the used medication. An anesthesiologist will prepare the drug, Who has no role in evaluating the patient. Then it will deliver to the anesthesiologist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan university of medical sciences
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
4318198167
Approval date
2019-07-12, 1398/04/21
Ethics committee reference number
IR.ZAUMS.REC.1398.267
Health conditions studied
1
Description of health condition studied
Chills
ICD-10 code
R68.83
ICD-10 code description
Chills (without fever)
Primary outcomes
1
Description
Cesarean section postoperative shivering with spinal anesthesia
Timepoint
The presence of Shivering will evaluate at 15, 30, 45, and 60 minutes after medicine injection.
Method of measurement
Patient evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving Dexmedetomidine at a dose of 0.5 micrograms per kilogram
Category
Treatment - Drugs
2
Description
Intervention group: Receiving Meperidine at a dose of 0.4 milligrams per kilogram
Category
Treatment - Drugs
3
Description
Control group: Receiving 10 millilitre of sodium chloride 0.9%
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
ali ibn abi talib hospital
Full name of responsible person
Sofia Ahrari
Street address
ali ibn abi talib hospital, Salamat Blvd., Khalij fars highway.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
Sa_ahrari186@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Noormohammad Bakhshani
Street address
Zahedan university of medical sciences ,Dr. Hesabi Square, Khalij fars highway.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2116
Email
zaums.research@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Sofia Ahrari
Position
Resident in anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ali ibn abi talib hospital, Salamat Blvd., Khalij fars highway.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
Sa_ahrari186@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mehdi Heydari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Ali ibn abi talib hospital, Salamat Blvd., Khalij fars highway.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
Heydarimehdi1352@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sofia Ahrari
Position
Resident in anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
ali ibn abi talib hospital, Salamat Blvd., Khalij fars highway.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
Sa_ahrari186@yahoo.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