Comparison of dexmedetomedine and lidocaine 2% in controlling analgesia and hemodynamic changes in cataract surgery with local anesthesia
Design
This study will be a double-blind randomized clinical trial with parallel groups on 52 patients referred to Motahhari Hospital in Jahrom who undergo cataract surgery. Patients participating in the study will be divided into two groups by tossing coins.
Settings and conduct
Patients referred to Motahhari Hospital in Jahrom who will undergo cataract surgery will be included in the study. Patients participating in the study will be divided into two groups of dexmedetomidine and lidocaine by throwing coins. The person participating in the study, the researcher and the data collector will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients referred to Motahhari Hospital in Jahrom who underwent cataract surgery and expressed their consent to participate in the study. Conditions of non-entry: includes patients with severe medical conditions to provide a suitable position in cataract surgery.
Intervention groups
Intervention group 1: They will receive 3 cc of lidocaine 2% retrobularly.
Intervention group 2: 5 μg / kg dexmedetomedin + 3 cc lidocaine 2% will receive retrobulbar.
Main outcome variables
Pain, hemodynamic changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N7
Registration date:2021-08-28, 1400/06/06
Registration timing:prospective
Last update:2021-08-28, 1400/06/06
Update count:0
Registration date
2021-08-28, 1400/06/06
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
2021-11-01, 1400/08/10
Expected recruitment end date
2022-03-03, 1400/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dexmedetomedine and lidocaine 2% in controlling analgesia and hemodynamic changes in cataract surgery with local anesthesia
Public title
Comparison of dexmedetomedine and lidocaine 2% in controlling analgesia and hemodynamic changes in cataract surgery with local anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having surgical indications
Indication of local anesthesia
Exclusion criteria:
The patient refuses local anesthesia even after careful consultation and explanation of the risks of this procedure
Uncontrolled Parkinson's patient
Patient with severe medical condition to limit the appropriate position in cataract surgery
Patient with a history of severe reactions
Allergy or other side effects to lidocaine or dexmedetomidine
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
52
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 who reviews the results and 2- the person who performs the injections, information about which patients received dextromethane or lidocaine alone, Do not have.
Placebo
Not 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
Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research
City
Jahrom
Province
Fars
Postal code
7167758256
Approval date
2021-08-23, 1400/06/01
Ethics committee reference number
IR.JUMS.REC.1400.031
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
E08.36
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic cataract
Primary outcomes
1
Description
Vital Signs
Timepoint
After retrobulbar block, one and two hours after the onset of retrobulbar block
Method of measurement
monitoring
2
Description
the pain
Timepoint
One and two hours of retrobulbar block
Method of measurement
VAS criteria
Secondary outcomes
1
Description
Intraocular pressure
Timepoint
Before and after retrobulbar block
Method of measurement
Tonometry
Intervention groups
1
Description
Intervention group 1: They will receive 3 cc of lidocaine 2% retrobularly.
Category
Treatment - Drugs
2
Description
Intervention group 2: 5 μg / kg dexmedetomedin + 3 cc lidocaine 2% will receive retrobulbar.