Dexmedetomidine in IVRA

NCT ID: NCT05123170

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-28
• Study Completion Date: 2021-06-20

Brief Summary

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

Detailed 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.

Conditions

Regional Anesthesia Morbidity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Group I

Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) alone diluted with normal saline 0.9% to make the final volume 30 ml

Group Type: ACTIVE_COMPARATOR

Lidocaine IV

Intervention Type: DRUG

Intravenous regional anaesthesia

Group II

Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.25 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine Injectable Solution [Dexdomitor]

Intervention Type: DRUG

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

Intervention Type: DRUG

Intravenous regional anaesthesia

Group III

Patients will receive 3 mg/kg of 2% lignocaine (maximum dose 300 mg) plus dexmedetomidine 0.5 μg/kg diluted with normal saline 0.9% to make the final volume 30 ml

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine Injectable Solution [Dexdomitor]

Intervention Type: DRUG

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

Intervention Type: DRUG

Intravenous regional anaesthesia

Interventions

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

Intervention Type: DRUG

Lidocaine IV

Intravenous regional anaesthesia

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

mostafa saieed fahim mansour

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sadek AM Sadek, MD

Role: STUDY_CHAIR

Menoufia University

Locations

Menoufia University

Shibīn al Kawm, Menoufia, Egypt

Countries

Egypt

Other Identifiers

2/2020ANET11

Identifier Type: -

Identifier Source: org_study_id