Protocol summary

Study aim
Determination of the effect of intravenous Dexmedetomidine and Meperidine in the treatment of post spinal shivering in cesarean section.
Design
This randomized, double-blind clinical trial with parallel groups and phase 2-3 will be conducted on 246 pregnant patients aged 18 to 46 who are candidates for caesarean section under spinal anesthesia who experience shivering after anesthesia, and block randomization is used for randomization.
Settings and conduct
After spinal anesthesia and ensuring sensory block at the T4 level, all patients will be prepped and covered with a double layer of surgical drapes and the surgery will begin. During surgery and recovery, patients will be checked for shivering. In case of shivering in group A , patients will receive meperidine 0.5mg/kg and in group B , patients will receive dexmedetomidine 0.5ug/kg after umbilical cord clamping with a total volume of 20ml within 10 minutes.Then the intensity of shivering, blood pressure, heart rate, spo2, and sedation score will be measured at intervals of 5, 10, 15, 20, and 30 minutes after the administration of the drugs. Nausea, vomiting, and dizziness will also be checked.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Withdrawal from participation of the study; 18 to 46 years old; Parturient patients with post spinal shivering. Exclusion criteria: Withdrawal from participation of the study; Cardiac and pulmonary diseases,; Eclampsia and preeclampsia; Contraindications of spinal anesthesia; History of seizures or Parkinson; Intraoperative transfusion; Taking sedative and vasodilator drugs; Dysautonomia; Allergy to the drugs.
Intervention groups
After spinal anesthesia and the start of surgery, if there is shivering , the patients are randomly assigned to one of the two groups of meperidine and dexmedomidine .
Main outcome variables
Intensity of [post spinal shivering.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120915010841N27
Registration date: 2022-09-03, 1401/06/12
Registration timing: prospective

Last update: 2022-09-03, 1401/06/12
Update count: 0
Registration date
2022-09-03, 1401/06/12
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous Dexmedetomidine and Meperidine in the treatment of post spinal shivering in cesarean section
Public title
postoperative shivering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Conscious consent to participate in the study Parturients candidate for cesarean section under spinal anesthesia 18 to 46 years old Patients with shivering during surgery or in recovery with a grade of more than 2
Exclusion criteria:
Withdrawal from participation of the study Cardiac and pulmonary, hepatic, renal diseases, hypertension, diabetes, arrhythmia and heart failure Eclampsia and preeclampsia Contraindications of spinal anesthesia (high ICP, hypovolemia, anemia, coagulation disorders) History of seizures or Parkinson's disease Intraoperative transfusion History of taking sedative-hypnotic and vasodilator drugs Dysautonomia Allergy to the drugs
Age
From 18 years old to 46 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 246
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the quadruple Block Randomization method. For this purpose, we prepare four sheets of paper.Write the letter A on two sheets and the letter B on the other two sheets. Mix the sheets together and place them in the desk drawer. With the referral of each eligible patient, one of the sheets is randomly taken out and based on this sheet is A or B, it will be assigned to one of the two groups of Dexmedetomidine and Meperidine. After randomly pulling out all four sheets, all the papers are returned to the drawer and the above procedure will be continued for the next four patients until the desired sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
After spinal anesthesia and the start of surgery and delivery of the baby, if the patient experiences shivering, she will receive one of the drugs Dexmedomidine and Meperidine,which is prepared in syringes with the same size and shape and labeled A and B by the nurse of anesthesia who is not involved in collecting or recording data.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Mahdieh Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2022-07-23, 1401/05/01
Ethics committee reference number
IR.UMSHA.REC.1401.389

Health conditions studied

1

Description of health condition studied
Treatment of intra or postoperative shivering
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery

Primary outcomes

1

Description
Shivering intensity
Timepoint
In 5,10,15 and 20 minutes after the administration of meperidine and dexmedomidine drugs.
Method of measurement
Observation based on crossley score of shivering

Secondary outcomes

1

Description
Systolic and diastolic blood pressure
Timepoint
Before injection and in 5,10,15,20 and 30 minutes after the administration of shivering drugs
Method of measurement
Non-invasive automatic barometric device

2

Description
Heart Rate
Timepoint
Before injection and in 5,10,15,20 and 30 minutes after the administration of shivering drugs.
Method of measurement
Pulse oximetry

3

Description
Percentage of arterial oxygen saturation
Timepoint
Before injection and in 5,10,15,20 and 30 minutes after the administration of shivering drugs.
Method of measurement
Pulse oximetry

4

Description
Nausea & vomiting
Timepoint
After the injection of drugs for the treatment of shivering until the patient leaves the operating room
Method of measurement
Observation

5

Description
sedation score
Timepoint
Before injection and in 5,10,15,20 and 30 minutes after the administration of shivering drugs.
Method of measurement
Ramsy sedation score

6

Description
Dizziness
Timepoint
After the injection of drugs for the treatment of shivering until the patient leaves the operating room.
Method of measurement
Question from the patient

Intervention groups

1

Description
Intervention group: After spinal anesthesia and ensuring sensory block at the T4 level, all patients will be prepped and covered with a double layer of surgical drapes and the surgery will begin. During surgery and recovery, patients will be checked for shivering. In case of shivering in group A , patients will receive meperidine 0.5mg/kg after umbilical cord clamping with a total volume of 20ml within 10 minutes .
Category
Treatment - Drugs

2

Description
Intervention group: After spinal anesthesia and ensuring sensory block at the T4 level, all patients will be prepped and covered with a double layer of surgical drapes and the surgery will begin. During surgery and recovery, patients will be checked for shivering. In case of shivering in group B , patients will receive dexmedetomidine 0.5ug/kg after umbilical cord clamping with a total volume of 20ml within 10 minutes .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian
Street address
Fatemieth Hospial, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
hp.fatemieh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Mahdie Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professorا
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Email
manuchehriann@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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