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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02920905

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

37.5

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Lidocaine Drug: atracurium Drug: Mg sulphate	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Apr 1, 2017

Actual Study Completion Date :

Apr 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: lidocaine

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

Drug: 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.

Experimental: 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.

Drug: Lidocaine

Drug: atracurium

Experimental: 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.

Drug: Lidocaine

Drug: atracurium

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University Hospital	Assiut		Egypt
2		Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

shimaa mamdouh mekkawy, resident doctor at anesthesia and ICU ,Assiut Univesity, Assiut University

ClinicalTrials.gov Identifier:

NCT02920905

Other Study ID Numbers:

Li,atr,mg in ivra

First Posted:

Sep 30, 2016

Last Update Posted:

Jun 12, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Pain, Postoperative

Lidocaine

Atracurium

Study Results

No Results Posted as of Jun 12, 2018