Evaluation of the Effect of Adding Ondansetron, Pethidine, and Dexmedetomidine to 5% Marcaine via the Neuraxial Route in Controlling Shivering in Patients Undergoing TURP
Design
Parallel groups, double-blind, randomized design.Randomization will be performed using an online program available on www.sealedenvelope.com.
Settings and conduct
Methods
This randomized clinical trial will include 81 TURP candidates referred to Vali-Asr and Amir al-Momenin Hospitals in Arak who meet the inclusion criteria. Patients will be randomly assigned into three equal groups receiving Ondansetron, Pethidine, or Dexmedetomidine.
After IV line placement and confirmation of IV patency, patients will receive 5 mL/kg of crystalloid fluid as a compensatory volume expander. Spinal anesthesia will be administered using a B. Braun needle at the L4-L5 or L5-S1 space, and the study drugs, pre-prepared in 5 mL volumes, will be injected.
Following surgery, patients will be transferred to the recovery room in the supine position. Vital signs, shivering score, pain score, pulse rate, MAP, and SpO₂ will be monitored and recorded by a blinded intern to ensure unbiased data collection.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Patients undergoing TURP referred to Vali-Asr and Amir al-Momenin Hospitals in Arak.
Exclusion Criteria:
• Conversion to general anesthesia.
Intervention groups
Men aged 35 to 70 years who are candidates for TURP surgery.
Main outcome variables
Average shivering score of patients in recovery/Average MAP of patients in recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250112064367N1
Registration date:2025-02-06, 1403/11/18
Registration timing:prospective
Last update:2025-02-06, 1403/11/18
Update count:0
Registration date
2025-02-06, 1403/11/18
Registrant information
Name
Fatemeh Akhavan malayeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3224 2043
Email address
fateme.akhavan2021@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-21, 1404/01/01
Expected recruitment end date
2025-12-21, 1404/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Ondansetron, Pethidine, Dexmedetomidine as adjuant therapy to neuroaxial Marcaine 5% in postoperative shivering in patients undergoing TURP
Public title
The effect of ondansetron, pethidine, and dexmedetomidine on postoperative shivering.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing TURP referred to Vali-Asr and Amir Al-Momenin Hospitals in Arak.
Patients with informed consent for participation in the study.
Patients aged 35 to 70 years
Patients classified as ASA Class I and II
Patients with no cardiovascular, respiratory, or renal diseases.
Patients with no history of cerebrovascular accident (CVA).
Patients who are not IV drug abusers
All patients undergoing spinal anesthesia
No allergy to Marcaine, Ondansetron, Pethidine, or Dexmedetomidine.
Exclusion criteria:
All patients for whom spinal anesthesia fails during surgery, requiring conversion to general anesthesia.
All patients who experience cardiopulmonary arrest for any reason during surgery.
All patients who, for any reason, require general anesthesia.
Age
From 35 years old to 70 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned into three equal groups using a blocked randomization method with blocks of six.
The random sequence is generated using an online program available on www.sealedenvelope.com. (https://www.sealedenvelope.com/)
Allocation concealment is ensured using the opaque sealed envelope method.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted in a double-blind design.
All patients will be randomly allocated into three equal groups using a block randomization method.
Medications will be prepared and labeled as A, B, and C under the supervision of the principal investigator, with the preparation carried out by a trained anesthesia technician. The principal investigator will be aware of the group allocations.
The intern, responsible for data collection and questionnaire completion, will remain blinded to the group assignments to ensure unbiased outcome assessment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Building 870, Deylami Ave, Azod Ave, Abbas Abbad Street, Arak
City
Arak
Province
Markazi
Postal code
3813663817
Approval date
2025-01-07, 1403/10/18
Ethics committee reference number
IR.ARAKMU.REC.1403.294
Health conditions studied
1
Description of health condition studied
postoperative shivering in patients undergoing TURP
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The occurrence or absence of shivering in patients.
Timepoint
The occurrence of shivering and pain score in patients at 2, 4, 6, and 8 hours postoperatively.
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Group 1:Patients will receive 75 mg of Bupivacaine (Exir Pharmaceutical, Iran) combined with 1–1.5 cc of Ondansetron (Caspian Tamin Pharmaceutical, Iran) via the neuraxial route.
Category
Treatment - Drugs
2
Description
Group 2:Patients will receive 75 mg of Bupivacaine (Exir Pharmaceutical, Iran) combined with 10–15 mg of Pethidine (Aburaihan Pharmaceutical, Iran) via the neuraxial route.
Category
Treatment - Drugs
3
Description
Group 3:Patients will receive 75 mg of Bupivacaine (Exir Pharmaceutical, Iran) combined with 10–15 mcg of Dexmedetomidine (Exir Pharmaceutical, Iran) via the neuraxial route.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Rasoul Jafari
Street address
Hazrat Vali Asr Educational and Medical Center, Hazrat Vali Asr Square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Rasoul Jafari
Street address
Hazrat Vali Asr Educational and Medical Center, Hazrat Vali Asr Square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Rasoul Jafari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Hazrat Valiasr Educational and Medical Center, Hazrat Valiasr Square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
Fateme.akhavan2021@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Rasoul Jafari
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Hazrat Valiasr Educational and Medical Center, Hazrat Valiasr Square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3223 1283
Email
fateme.akhavan2021@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
فاطمه اخوان ملایری
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Education
Street address
Building 870, Deylami Ave, Azod Ave, Abbas Abbad Ave, Arak
City
Arak
Province
Markazi
Postal code
3813663817
Phone
+98 86 3224 2043
Email
fateme.akhavan2021@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Final result
When the data will become available and for how long