Research on the effect of dexmedetomidine on improving the quality of spinal anesthesia with bupivacaine in lower limb surgeries
Design
A phase 2, double-blind, randomized, parallel-group, controlled clinical trial was used on 60 patients for simple randomization.
Settings and conduct
The location of the study is Besat Hospital in Hamadan. The study type is a double-blind randomized clinical trial.The research population is patients referred to Besat Hospital in Hamadan who are candidates for lower limb surgery, and the research sample is any patient eligible for lower limb surgery with spinal anesthesia who refers to Besat Hospital and meets the study inclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No history of hypertension - No allergy to the study drugs
Inclusion criteria: Infection at the injection site - Coagulation problem
Intervention groups
Intervention group: 1.5 cc of 0.5% hyperbaric bupivacaine plus 5 micrograms of sufentanil along with 5 micrograms of dexmedetomidine (0.5 ml, reconstituted with dexmedetomidine)
Control group: Normal saline (0.5 ml, reconstituted with normal saline) along with 1.5 cc of 0.5% hyperbaric bupivacaine plus 5 micrograms of sufentanil
Main outcome variables
Assessment of pain in the postoperative period, cumulative use of rescue analgesics
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241211064021N14
Registration date:2026-01-04, 1404/10/14
Registration timing:prospective
Last update:2026-01-04, 1404/10/14
Update count:0
Registration date
2026-01-04, 1404/10/14
Registrant information
Name
Faeze Noori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3131 4033
Email address
ethics@umsha.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-01-05, 1404/10/15
Expected recruitment end date
2026-12-20, 1405/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding dexmedetomidine to 0.5% hyperbaric bupivacaine on the quality of spinal anesthesia in lower limb surgeries
Public title
Evaluation of the effect of adding dexmedetomidine to 0.5% hyperbaric bupivacaine on the quality of spinal anesthesia in lower limb surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years
No use of drugs affecting the central nervous system and anesthesia within the past 24 hours.
Informed consent to participate in the study
Exclusion criteria:
history of hypertension
allergies to the drugs being studied
Age
From 25 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used to implement random assignment. In this way, 60 consecutive numbers (from 1 to 60) will be written separately on paper and placed in a container.Each participant in the experiment is then asked to randomly select one of these 30 numbers from a container of numbers. Those who selected numbers 1 to 30 will be assigned to Group A ("Intervention Group 1"), and those who selected numbers 31 to 60 will be assigned to Group B ("Intervention Group 2").
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blinding is performed in a double-blind manner, so that neither the patient nor the anesthesiologist responsible for the injection is aware of the group assignment. Drug solutions are prepared by someone other than the researchers and are identical in volume, color, and appearance. Group coding remains hidden until the end of statistical analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2025-11-15, 1404/08/24
Ethics committee reference number
IR.UMSHA.REC.1404.688
Health conditions studied
1
Description of health condition studied
Studying the effect of dexmedetomidine on improving the quality of spinal anesthesia with bupivacaine in lower limb surgeries
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Severity of pain after surgery in the early hours
Timepoint
At intervals of 6, 12 and 24 hours after the completion of surgery
Method of measurement
Visual Pain Scale and Numerical Pain Scale
Secondary outcomes
1
Description
Duration of need for oral painkillers
Timepoint
Until discharge.
Method of measurement
Record the number of days the patient required oral painkillers (other than usual home remedies) to control pain.
Intervention groups
1
Description
In the intervention group, patients will receive dexmedetomidine. The drug is administered at a dose of 0.5 micrograms per kilogram of body weight as a slow intravenous infusion over 10 minutes before induction of general anesthesia. The purpose of administering this drug is to investigate its effects on reducing stress, the need for anesthetic drugs, and hemodynamic stabilization during surgery. During and after surgery, the patients' state of consciousness and vital signs will be recorded and monitored. No other sedative or anesthetic drugs will be changed at this stage, and all patients will be under the supervision of an anesthesiologist
Category
Treatment - Drugs
2
Description
In the control group, instead of dexmedetomidine, patients receive an equal volume of normal saline (0.9%) as a slow intravenous infusion over the same period of time (10 minutes before induction of anesthesia). Patients in this group will also be placed under the same general anesthesia conditions and other anesthetics will be administered as in the intervention group. During and after the procedure, vital signs, level of consciousness, and need for anesthetics will be monitored and recorded to allow for a precise comparison between the two groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital, Hamadan City
Full name of responsible person
Puran Hajian
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
fadaeiebad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
fadaeiebad@gmail.com
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
Ebadollah Fadaei Athar
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
fadaeiebad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ebadollah Fadaei Athar
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Fahmedeh
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
fadaeiebad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ebadollah fadaei athar
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Fahmedeh
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
fadaeiebad@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
All potential data can be shared after de-identifying individuals
When the data will become available and for how long
After printing the article
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
There is no prohibition to access the data
From where data/document is obtainable
Ebadollah fadaei athar
What processes are involved for a request to access data/document
First, send an email to fadaeiebad@gmail.com and introduce yourself.