Dexmedetomidine in IVRA

Regional Anesthesia Morbidity Clinical Trial

Official title:

Comparison of Two Different Doses of Dexmedetomidine Added to Lignocaine in Patients Posted for Upper Limb Orthopedic Surgery Under Intravenous Regional Anaesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05123170
• Other study ID #: 2/2020ANET11
• Status: Completed
• Phase: Phase 4
• Start date: February 28, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: January 2022
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective randomized controlled double-blinded study will be conducted on 90 patients assigned randomly into three equal groups,

Description:

After obtaining approval of the medical and ethical committee of Menoufia University & Nasser Institute for Research and Treatment, an informed and written consent from the patients, a prospective controlled randomized double blinded study will be performed

Sample size:

MedCalc® version 12.3.0.0 program "Ostend, Belgium" was used for calculations of sample size, statistical calculator based on 95% confidence interval and power of the study 80% with α error 5%, According to a previous study (13), showed that the duration of tourniquet time in group A was mean 51.60±5.157 and Group B was mean 53.80±4.773, with p-value >0.05, while Quality of block of excellent in group A 83.3% and group B 90%, it turns out that there is success in the group B compared to group A, but there is no difference. So it can be relied upon in this study, based on this assumption, sample size was calculated according to these values produced a minimal samples size of 86 cases were enough to find such a difference. Assuming a drop-out ratio of 5%, the sample size will be 90 cases, subdivided into three groups 30 cases in each group. Patients will be randomly categorized into three equal groups (30 patients each): The patients will be randomly allocated to one of these three groups, using a computer-generated sequence of random numbers and a sealed envelope technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 20, 2021
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients of ASA class I and II.

• Patients of either sex.

• Patients aged between 20-70 years.

• Patients scheduled for forearm and hand surgery lasting for about 60 minutes.

Exclusion Criteria:

• Patient with known hypersensitivity to any study medications.

• Patient with Severe peripheral vascular disease and neurological disease.

• Where use of tourniquet will be either not possible or contraindicated.

• Patient with Hemolytic diathesis specially sickle cell anemia, epilepsy, diabetes mellitus, hypertension, cardiovascular disease like myocardial infarction, cardiac arrhythmias, heart block and altered mentation.

• Procedures lasting for more than 90 min will be also not considered.

• Therapy with adrenergic receptor antagonist, calcium channel blocker and ACE inhibitors.

• Patient with impaired liver function.

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity

Intervention

Drug:
• Dexmedetomidine Injectable Solution [Dexdomitor]
two different doses of dexemedetomidine (0.25 µg /kg and 0.5 µg/kg) as adjunct to lignocaine in intravenous regional anesthesia for upper limb orthopedic surgeries
• Lidocaine IV
Intravenous regional anaesthesia

Locations

Country	Name	City	State
Egypt	Menoufia University	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hollmen scale	change from base line for the scale (scale from 1 to 4)	2 hours
Primary	modified bromage scale	change from baseline for the scale (scale from 0 to 4 )	2 hours
Secondary	visual analogue score	changes in the scale from 0 to 10	2 hours
Secondary	ramsey sedation score	changes in the scale from 1 to 4	2 hours