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

• Status: Recruiting
• Trial end date: 2021-03-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Fentanyl

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).