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Analgesic effect of adding dexmedetomidine and or nitroglycerin (NTG) to lidocaine for intravenous regional anesthesia: a randomized clinical trial.

Analgesic effect of adding dexmedetomidine and or nitroglycerin (NTG) to lidocaine for intravenous regional anesthesia in patients scheduled for forearm surgery.

Status
Suspended
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000838415
Enrollment
4
Registered
2016-06-27
Start date
2016-06-02
Completion date
2016-06-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this study is to evaluate the effect of adding dexmedetomidine and or nitroglycerin (NTG) to lidocaine on the quality of intravenous regional anesthesia (IVRA) in patients scheduled for hand or forearm surgery.

Interventions

The patients will be randomly allocated into four groups (20 patients in each group): group I (lidocaine group; the control group) will receive 3 mg/kg of Lidocaine alone. The other three groups will receive the same amount of Lidocaine plus 1 microgram/kg dexmedetomidine in group II (dexmedetomidine group), 200 microgram nitroglycrin (NTG) in group III (nitroglycerin group) and 1 microgram/kg dexmedetomidine + 200 microgram NTG in group IV (dexmedetomidine-nitroglycerin group). In all groups t

The patients will be randomly allocated into four groups (20 patients in each group): group I (lidocaine group; the control group) will receive 3 mg/kg of Lidocaine alone. The other three groups will receive the same amount of Lidocaine plus 1 microgram/kg dexmedetomidine in group II (dexmedetomidine group), 200 microgram nitroglycrin (NTG) in group III (nitroglycerin group) and 1 microgram/kg dexmedetomidine + 200 microgram NTG in group IV (dexmedetomidine-nitroglycerin group). In all groups the study drugs will be diluted with 0.9% normal saline to a total volume of 40 ml and will be prepared in identical syringes by an anesthetist not involved in the study protocol.On arrival to operating room, the patients will be monitored for heart rate (using ECG), oxygen saturation (using pulse oximetry), arterial blood pressure (non -invasive measurement of systolic, diastolic and mean values every 5 minutes) and the baseline values will be recorded. For each patient two intravenous cannulae will be inserted; the first (22-guage or smaller) in a distal vein of the operative hand for slow injection of the study drugs for intravenous regional anesthesia (IVRA) and will be removed immediately after injection of the anesthetic solution, and the second cannula will be inserted in the hand of the contra-lateral side for intraoperative fluid transfusion. An Esmarch bandage will be used for exsanguination of the operative arm after its elevation for 5 minutes then, a double cuffed pneumatic tourniquet will be wrapped around the upper arm. The proximal cuff will be inflated between 30 and 90 minutes at the discretion of the treating anaesthetist to 100 mm Hg above the systolic pressure of the patient or at least 250 mm Hg. IVRA will be achieved with slow injection of the study solution according to the patient's group. After the onset of sensory and motor block, the distal cuff of the tourniquet will be inflated to 250 mm Hg, and the proximal cuff will be released. Tourniquet pain, will be assessed using visual analogue scale (VAS) score (where o= no pain and 10 = the most severe pain) will be measured and recorded before and 5, 10, 15, 20, 25 and 30 min after injection of anesthetic solution if the VAS more than 3 the patient will receive 50 microgram fentanyl intravenous bolus. After the end of surgery deflation of the cuff will done using a “deflation/re-inflation” technique for 3 cycles of deflation of the cuff for 5 seconds and then re-inflation for 1 minute.

Sponsors

Hoda Alsaid Ahmed Ezz
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Eighty patients of both sex, aged (20 - 60) years scheduled for hand or forearm surgery, ASA physical status class I and II

Exclusion criteria

Patients with open fractures of upper limb, sickle cell anemia, peripheral vascular insufficiency, cardiac disease, hypertensive patients, liver or, kidney disease, patients who are taking any analgesia within the previous 24 h, or history of drug allergy, will be excluded from the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026