Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in IVRA

NCT ID: NCT02920905

Last Updated: 2018-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-04-30

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

Conditions

Postoperative Pain

Study Design

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

Study Groups

lidocaine

• Patients in group A will receive 3 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.

Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.

lidocaine & atracurium

• Patients in group B receive 3 mg/kg of lidocaine 2% + 2 mg atracurium diluted with saline to a total volume of 40 ml.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.

Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.

atracurium

Intervention Type: DRUG

Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.

Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.

lidocaine & atracurium & Mg sulphate

• 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.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.

Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.

atracurium

Intervention Type: DRUG

Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.

Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.

Mg sulphate

Intervention Type: DRUG

Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.

Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse . The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.

Interventions

Lidocaine

Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.

Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.

Intervention Type: DRUG

atracurium

Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.

Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.

Intervention Type: DRUG

Mg sulphate

Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.

Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse . The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.

Intervention Type: DRUG

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 .

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

shimaa mamdouh mekkawy

resident doctor at anesthesia and ICU ,Assiut Univesity

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hamdy Abbas Youssef, Prof

Role: STUDY_DIRECTOR

Assiut University

. Ola Mahmoud Wahba, Ass Prof

Role: STUDY_DIRECTOR

Assiut University

Ghada Mohammad Abo Elfadl, Lecturer

Role: STUDY_DIRECTOR

Assiut University

Locations

Assiut University Hospital

Asyut, , Egypt

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Li,atr,mg in ivra

Identifier Type: -

Identifier Source: org_study_id