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Effect of Intravenous Magnesium on Post-spinal Fentanyl Induced Pruritus Incidence

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ClinicalTrials.gov Identifier: NCT04160598
Recruitment Status : Not yet recruiting
First Posted : November 13, 2019
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Abd Latif Ghanim, Mansoura University

Brief Summary:

Introduction: Adding opioids to local anesthetic solutions leads to enhanced anesthesia and provide postoperative analgesia. Intrathecaly injected opioids have some side effects, though. One of them is pruritus. Objective: We designed a randomized, double‐blinded, placebo‐controlled study to evaluate prophylactic impact of continuous IV Magnesium 10mg/kg over 30 minutes on intrathecal fentanyl‐induced pruritus start at the end of the operation.

Methods: ASA I‐II Patient's candidate for orthopedic operations under spinal anesthesia (10‐15mg hyperbaric bupivacaine and 25 µg fentanyl intrathecal) and will be divided randomly into two groups:

Control group (Placebo group): bolus 100 ml nacl 0.9% at end of surgery Study group (Mg ++ group): (continuous IV Magnesium 10mg/kg in 100 ml Nacl0.9% over 30 minutes at end of surgery).

Study outcome:

  1. Hemodynamics: Systolic blood pressure, Mean arterial blood pressure, pulse rate, O2 saturation will be recorded in 5 min,10 min,30 min,60 min and every one hour till 6 hours after the operation.
  2. Pruritus Patients were asked about existence (present=1,no=0), severity (mild=1, modret=2, sever =3) and site of pruritus (Face(trigeminal) =1, neuroaxial(dermatome)=2), 1,2,4, and 6 hours after operation. Incidence of pruritus total group incidence %.
  3. The incidence of PONV.

Condition or disease Intervention/treatment Phase
Magnesium Infusion in Post-spinal Opioid Pruritis Drug: IV infusion Drug: intrathecal fentanyl Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Intravenous Magnesium on Post-spinal Fentanyl Induced Pruritus Incidence; A Prospective Randomized Controlled Study
Estimated Study Start Date : November 20, 2019
Estimated Primary Completion Date : March 20, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Placebo Comparator: Placebo group
bolus 50 ml nacl 0.9% at the end of surgery over 20 minutes 5ml/minute infusion rate.
Drug: IV infusion
Control group (Placebo Group): bolus 50 ml Nacl 0.9% at the end of surgery over 20 minutes 5ml/minute infusion rate.

Drug: intrathecal fentanyl
10‐15mg hyperbaric bupivacaine and 30µg fentanyl intrathecally injected

Experimental: IV Mg ++ group
continuous IV infusion pump of Magnesium 10mg/kg in 50 ml Nacl0.9% over 20 minutes at end of surgery 5ml/minute infusion rate.
Drug: IV infusion
Control group (Placebo Group): bolus 50 ml Nacl 0.9% at the end of surgery over 20 minutes 5ml/minute infusion rate.

Drug: intrathecal fentanyl
10‐15mg hyperbaric bupivacaine and 30µg fentanyl intrathecally injected




Primary Outcome Measures :
  1. Incidence of pruritus in each group incidence %. [ Time Frame: during the 1st 6 hours after spinal fentanyl injection. ]
    Existence,Severity, Site of pruritus (Face (trigeminal) =1, neuraxial (dermatome) =2)



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

ASA I‐II Both genders Aged 20-70 years old Patient's candidate for LL orthopedic operations under spinal anesthesia

Exclusion Criteria:

BMI>35 Patient refusal Hypersensitivity to amide local anesthetics Fentanyl opioids Magnesium and naloxone. Patients with LBBB and trifacicular block General contraindications to spinal anesthesia surgeon total refusal Cardiac, hepatic, renal or respiratory failure Difficult communication with the patient (psychological or deafness).


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Responsible Party: Mohamed Abd Latif Ghanim, Associate Professor os anesthesia ICU & Pain medicine., Mansoura University
ClinicalTrials.gov Identifier: NCT04160598    
Other Study ID Numbers: R.19.09.628.R1.R2
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Abd Latif Ghanim, Mansoura University:
Neuraxial opioids, post-operative itching, intrathecal Fentanyl pruritus, Spinal anesthesia
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics