Determination of the effects of Iv dexamethasone and dexmedetomidine on spinal anesthesia(SA) level in opium addicted patients
Design
Clinical Trial , Two Parallel Groups , Double-Blinded , Randomized, Phase 3,In 60 Patients
Settings and conduct
Patients will divide into two groups Dexamethasone (A) and Dexmedetomidine (B) based on a random number table. 10 min before SA, Dexamethasone will be injected in group A and Dexmedetomidine in group B. SA will be done the same for all patients .
During surgery, normal saline infusion will continue for group A and dexmedetomidine infusion will continue for group B . Patients will undergo sensory and motor evaluations at intervals. The person performing SA is the same person who will assess the spinal levels and is not aware of the type of group. The patient also does not know the type of group. Another anesthesiologist who is aware of the type of drugs and the group will give the drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
ASA class 1.2,Age 18 to 65 yrs ,opium addiction ,BMI <30
Exclusion criteria :Pregnancy, Dissatisfaction with SA, Coagulation disorders, neurologic disorder ,Local infection in the lumbar region
Sensitivity to local anesthetic
Intervention groups
Intervention in the Dexamethasone group is infusion of 8 mg Dexamethasone 10 min before SA and then infusion of 0.5 micro/Kg/hr of normal saline during surgery.
Intervention in Dexmedtomidine group is infusion of 0.5 micro/Kg/hr for 10 min before SA and then infusion of the same drug at a rate of 0.5 micro/Kg/hr during surgery.
Main outcome variables
The onset of sensory block
The onset of motor block
Duration of motor block
Time of two level regression of sensory block
The first time for analagesic requirement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120430009593N15
Registration date:2021-12-01, 1400/09/10
Registration timing:prospective
Last update:2021-12-01, 1400/09/10
Update count:0
Registration date
2021-12-01, 1400/09/10
Registrant information
Name
Elham Memary
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 7755 8082
Email address
drmemary@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-21, 1400/09/30
Expected recruitment end date
2022-12-20, 1401/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between intravenous Dexamethasone and Dexmedtomidine on spinal anesthesia level in opium addicted patients
Public title
Effect of intravenous Dexmedetomidine and Dexamethasone on spinal anesthesia in opium addicted patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with drug addiction
Patients with ASA class 1,2
Patients with BMI <30
Patients aged 18 to 65 years
Exclusion criteria:
Pregnant patients
Patients with dissatisfaction with spinal anesthesia
Patients with coagulation disorders
Patients with a history of multiple sclerosis
Patients with local infection in the lumbar region
Patients with allergies to local anesthetics
Patients with systemic infections
Patients with diabetic neuropathy
Patients with bradycardia with less than 50 HR
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
27
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method :
Randomization : Simple
Randomization Unit: based on patient
Randomization Tool: Random Number Table - Block stratified randomization software window version 6.0.
Using this software, a random number table will be created and accordingly , the sample will be divided into two groups of 30 patients in such a way that at the beginning of each person's entry, his / her number will be matched with the table so the type of group, dexmedetomidine or dexamethasone , will be specified.
The participants will not aware of the allocation of groups and won't know that the study will have two groups. The drugs will be given by first anesthesiologist who knows the groups. The person who will assess the outcome (the second anesthesiologist ) also won't be aware of the group .
Blinding (investigator's opinion)
Double blinded
Blinding description
The person performing the spinal anesthesia, is the same person who will evaluate the spinal levels and does not know about the group .The patients
also does not know the type of group. Another anesthesiologist who knows the type of drugs and the group will give the drugs
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ShahidBeheshti University of Medical Sciences
Street address
Shahid Chamran Highway, Yemen St., next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-07-13, 1400/04/22
Ethics committee reference number
IR.SBMU.MSP.REC.1400.202
Health conditions studied
1
Description of health condition studied
Dexmedetomidine and Dexamethasone on Spinal Anesthesia Level in Opium Addicted Patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Onset of Sensory Block
Timepoint
Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Minutes to 2 Hours
Method of measurement
Pinprick Test
2
Description
Onset of Motor Block
Timepoint
Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Minutes to 2 Hours
Method of measurement
Bromage Scale
3
Description
Duration of Motor Block
Timepoint
Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Every to 2 Hours
Method of measurement
Bromage Scale
4
Description
Regression of Two Level of Sensory Block
Timepoint
Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Minutes to 2 hours
Method of measurement
Pinprick Test
Secondary outcomes
1
Description
Total Analgesia Time
Timepoint
Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Minutes to 2 Hours
Method of measurement
ََAccording to Time with Visual Analogue Scale less than 3
2
Description
The First Time for Analgesia Requirement
Timepoint
Every 3 Minutes to 15 Minutes and then Every 5 Minutes to 30 Minutes and Every 15 Minutes to 2 Hours
Method of measurement
Analgesic Request According to VAS More than 3
Intervention groups
1
Description
Control group : Dexamethasone 8 mg 10 minutes before spinal anesthesia with bupivacaine and then normal saline infusion at a rate of 0.5 μg / kg / hr during surgery. Each Dexamesthasone ampule consists of 8 mg and belongs to Alborz Drug Company
Category
Treatment - Drugs
2
Description
Intervention group : Dexmedetomidine infusion at a dose of 0.5 micrograms per kilogram of body weight for 10 minutes before spinal anesthesia and then infusion at a dose of 0.5 micrograms per kilogram of body weight.Each Dexmedtomidine vial consists of 2 c.c (200microgram )and belongs to Exir Drug company