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

NCT04160598 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2020-09-04

No results posted yet for this study

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.

Conditions

  • Magnesium Infusion in Post-spinal Opioid Pruritis

Interventions

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • mohamed ghanem · Mansoura Faculty of Medicine-Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2021-03-20
Completion
2021-03-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04160598 on ClinicalTrials.gov