Comparing the Effect of Adding Dexmedetomidine and fentanyl to bupivacaine on pain and shivering in patients undergoing lower extremity orthopedic surgery using spinal anesthesia
Comparing the Effect of Adding Dexmedetomidine and fentanyl to bupivacaine on pain and shivering in patients undergoing lower extremity orthopedic surgery using spinal anesthesia
Design
This study will perform a two-way blind randomized clinical trial with parallel groups on 60 patients referred to Peymaniyeh Hospital in Jahrom who are undergoing lower limb orthopedic surgery. Patients participating in the study will be divided into three groups by throwing dice.
Settings and conduct
Patients referred to Jahrom's Peymaniyeh Hospital, who will undergo lower limb orthopedic surgery, will be included in the study. 10 ug fentanyl + 15 mg bupivacaine. Control group: 15 mg bupivacaine will be divided. The study participant, the researcher, and the data collector will be unaware of the type of medication being taken.
Participants/Inclusion and exclusion criteria
All patients referred to Peymaniyeh Hospital in Jahrom who have undergone lower limb orthopedic surgery and express their satisfaction to participate in the study and do not have the criteria to leave the study.
Intervention groups
Interventional group 1: 5 Microgram of dexamethasone + 15 mg of bupivacaine taken intrathecal.
The intervention group receives 2: 10 mg of fentanyl + 15 mg of bupivacaine taken intrathecal.
Control group: receiving 15 mg of bupivacainetaken intrathecal.
Main outcome variables
Pain, chills
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130926014779N4
Registration date:2020-05-29, 1399/03/09
Registration timing:registered_while_recruiting
Last update:2020-05-29, 1399/03/09
Update count:0
Registration date
2020-05-29, 1399/03/09
Registrant information
Name
Navid Kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5426 4192
Email address
k.navid@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-31, 1398/10/10
Expected recruitment end date
2020-06-24, 1399/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Adding Dexmedetomidine and fentanyl to bupivacaine on pain and shivering in patients undergoing lower extremity orthopedic surgery using spinal anesthesia
Public title
the Effect of Adding Dexmedetomidine and fentanyl to bupivacaine on pain and shivering in patients undergoing lower extremity orthopedic surgery using spinal anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Anesthesia class one and two
Exclusion criteria:
History of cardiovascular disease
History of narcotic use
Diabetes
Patients who suffered severe pain during the operation and had to undergo general anesthesia
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in the study were divided into three groups by throwing dice
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding in the present study, a double-blind method is used in a way that (1) the person who will review the results and (2) the person who performs the injections are unaware of which patients have received dexmedetomidine ،fentanil and bupivacaine alone.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Jahrom University of Medical Sciences
Street address
School of medicine, Motahhari Blvd, Jahrom
City
Jahrom
Province
Fars
Postal code
716775243
Approval date
2020-05-10, 1399/02/21
Ethics committee reference number
IR.JUMS.REC.1399.011
Health conditions studied
1
Description of health condition studied
Pain and chills in orthopedic patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
1, 2, 6, 12 and 24 hours after surgery
Method of measurement
Visual scale of pain
2
Description
chills
Timepoint
1, 2, 6, 12 and 24 hours after surgery
Method of measurement
Based on the Crossley division
Secondary outcomes
1
Description
Symptoms of hemodynamics
Timepoint
Before prescribing the drug under study, before spinal anesthesia, after anesthesia, and then every half hour until the end of surgery and during recovery
Method of measurement
By the device for measuring hemodynamic symptoms
2
Description
Nausea-vomiting
Timepoint
1, 2, 6, 12 and 24 hours after surgery
Method of measurement
questionnaire
Intervention groups
1
Description
Interventional group 1: 5 ug of dexamethasone + 15 mg of bupivacaine taken intrathecally
Category
Treatment - Drugs
2
Description
Intervention group 2: 10 ug fentanyl + 15 mg bupivacaine taken intrathecally.
Category
Treatment - Drugs
3
Description
Control group: receiving 15 mg of bupivacaine intrathecally.