Clinical trial NCT02920905: Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in IVRA
Official title: Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in Intravenous Regional Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 75
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The present clinical study will be undertaken to compare study between the effect of atracurium with lidocaine versus addition of magnesium sulphate to the same doses with lidocaine administrated alone in IntraVenous Regional Anaesthesia to access motor block, sensory block, tourniquet pain and post operative analgesia .Also assessment of patient and surgeon satisfaction .

Detailed description: patients will be divided randomly into three groups (A, B, C) of 25 each, according to computer generated table of random numbers.

* Patients in group A will receive 3 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.
* Patients in group B receive 3 mg/kg of lidocaine 2% + 2 mg atracurium diluted with saline to a total volume of 40 ml.
* Patients in group C will receive 3 mg/kg of lidocaine 2% + 2 mg atracurium mixed with 10 mg /kg magnesium sulphate diluted with saline to a total volume of 40 ml.

Onset of sensory block will be assessed by a pin prick performed at 1 minute interval in the dermatomal sensory distribution of the medial and lateral ante brachial cutaneous, ulnar, median and radial nerves. Sensory block onset time will be recorded as time elapsed from injection of drug to sensory block achieved in all dermatomes.Onset of motor block will be assessed by asking the subject to flex and extend his/her wrist and fingers. Monitoring of motor block will be assessed by Modified Bromage Score . Complete motor block will be recorded when no voluntary movement will be possible.

At the end of surgery, the tourniquet will be deflated by a cyclic deflation technique and recording this :

* Sensory block recovery time
* Motor block recovery time
* Mean arterial pressure (MAP),
* heart rate (HR)
* visual analogue scale (VAS) will be recorded at 0, 15 min , 1, 6, 12, and 24 h.
* The time to first analgesic requirement will be recorded (the time elapsed from tourniquet release until first patient request for analgesic).

Patient and surgeon satisfaction

Eligibility criteria: Inclusion Criteria:

* Short procedures (less than 2 hours).
* Cooperative patients.

Exclusion Criteria:

* Patients with sickle cell anemia.
* History of drug allergy.
* Raynaud's disease.
* Scleroderma.
* Myasthenia gravis.
* Cardiac disease.
* Diabetes mellitus.
* Peptic ulcer.
* Gastritis.
* Liver or renal insufficiency.
* Patients with history of convulsions .

Primary outcomes:
measure: postoperative analgesia
timeFrame: 24 hour
Secondary outcomes:
measure: The onset and recovary times of sensory and motor block , first analgesic request , tourniquet pain ,side effects of study drugs , and quality of anesthesia assessed by patients and surgeons
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
city: Assiut
country: Egypt
Study officials:
affiliation: Assiut University
name: Hamdy Abbas Youssef, Prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: . Ola Mahmoud Wahba, Ass Prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Ghada Mohammad Abo Elfadl, Lecturer
role: STUDY_DIRECTOR
References: