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NCT Number: NCT02920905

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

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 .

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Key information

Conditions

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

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assiut University Hospital, Asyut, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. postoperative analgesia

    Time frame: 24 hour

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

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

    Time frame: 24 hours

    Onset of sensory block assessed by pinbrick of the arm . 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in Intravenous Regional Anesthesia

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2016
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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