The effect of adding low dose of epinephrine with intrathecal bupivacaine and fentanyl on hemodynamic stability of patients undergoing orthopedic lower limb surgery:A Clinical trial study
The effect of adding low dose of epinephrine with intrathecal bupivacaine and fentanyl on hemodynamic stability of patients undergoing orthopedic lower limb surgery.
Design
This study will be a double-blind randomized clinical trial with parallel groups on 128 patients referred to Peymaniyeh Hospital in Jahrom who are undergoing orthopedic lower limb surgery. Patients participating in the study will be divided into two groups by tossing coins.
Settings and conduct
Patients referred to Peymaniyeh Hospital in Jahrom who will undergo orthopedic surgery of the lower extremities will be included in the study. Patients participating in the study will be divided into two groups by tossing coins. The study participant, researcher, and data collector will be unaware of the type of drug being used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients referred to Peymaniyeh Hospital in Jahrom who underwent lower limb orthopedic surgery and expressed their consent to participate in the study. Non-entry conditions: includes patients who do not have hemodynamic stability and suffer from acute and chronic pain.
Intervention groups
Intervention group 1: They receive 0.2 mg epinephrine + 25 micrograms fentanyl + 10 mg bupivacaine intrathecally. Intervention group 2: 10 mg bupivacaine + 25 μg fentanyl intrathecally.
Main outcome variables
Blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N4
Registration date:2021-06-13, 1400/03/23
Registration timing:prospective
Last update:2021-06-13, 1400/03/23
Update count:0
Registration date
2021-06-13, 1400/03/23
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding low dose of epinephrine with intrathecal bupivacaine and fentanyl on hemodynamic stability of patients undergoing orthopedic lower limb surgery:A Clinical trial study
Public title
The effect of adding low dose of epinephrine with intrathecal bupivacaine and fentanyl on hemodynamic stability of patients undergoing orthopedic lower limb surgery:A Clinical trial study
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Anesthesia class one and two
Exclusion criteria:
Diabetes
History of cardiovascular disease
Shortness of breath
Kidney or liver disease
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Patients participating in the present study were randomly divided into two groups by tossing coins.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the present study, the double-blind method is used so that 1- the person reviewing the results and 2- the person performing the injections do not know which patient received epinephrine.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Ethics Committee of Jahrom University of Medical Sciences
City
jahrom
Province
Fars
Postal code
7167758256
Approval date
2021-03-16, 1399/12/26
Ethics committee reference number
IR.JUMS.REC.1399.155
Health conditions studied
1
Description of health condition studied
Hemodynamics in lower limb orthopedic patients
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Blood pressure
Timepoint
Before prescribing the studied drug, before spinal anesthesia, after anesthesia and then every half hour until the end of surgery and during recovery will be measured and recorded.
Method of measurement
Monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They receive 0.2 mg epinephrine + 25 micrograms fentanyl + 10 mg bupivacaine intrathecally and in a single dose.
Category
Treatment - Drugs
2
Description
Control group: 10 mg bupivacaine + 25 micrograms fentanyl intrathecally and receive a single dose.