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

NCT02920905 | Completed Phase 3

• 1 other identifier: Li,atr,mg in ivra
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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 .

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• postoperative analgesia

  postoperative analgesia measured by VAS of 0-10 (0= no pain and 10=Worst pain imaginable ) during the first 24 hours

  24 hour

Secondary Outcomes (1)

• 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

  24 hours

Study Arms (3)

lidocaine

EXPERIMENTAL

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

Drug: Lidocaine

lidocaine & atracurium

EXPERIMENTAL

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

Drug: Lidocaine; Drug: atracurium

lidocaine & atracurium & Mg sulphate

EXPERIMENTAL

• 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.

Drug: Lidocaine; Drug: atracurium; Drug: Mg sulphate

Interventions

Lidocaine 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; lidocaine & atracurium; lidocaine & atracurium & Mg sulphate

atracurium 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; lidocaine & atracurium & Mg sulphate

Mg sulphate 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.

lidocaine & atracurium & Mg sulphate

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut University Hospital

Asyut, Egypt

Location

Unknown Facility

Asyut, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Atracurium

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzylisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hamdy Abbas Youssef, Prof

  Assiut University

  STUDY DIRECTOR

• . Ola Mahmoud Wahba, Ass Prof

  Assiut University

  STUDY DIRECTOR

• Ghada Mohammad Abo Elfadl, Lecturer

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at anesthesia and ICU ,Assiut Univesity

Study Record Dates

• First Submitted: August 25, 2016
• First Posted: September 30, 2016
• Study Start: November 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: June 12, 2018

Record last verified: 2018-06

Locations

EG (2)