Effect of Intravenous Magnesium on Post-spinal Fentanyl Induced Pruritus Incidence
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04160598 |
Recruitment Status :
Recruiting
First Posted : November 13, 2019
Last Update Posted : September 4, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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.
- 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 %.
- 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 |

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 |
Actual Study Start Date : | September 2, 2020 |
Estimated Primary Completion Date : | March 20, 2021 |
Estimated Study Completion Date : | March 30, 2021 |
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 |
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160598
Contact: mohamed Ghanem, A.professor | 00201067883998 | mohamed.abdel_latif@yahoo.com |
Egypt | |
Anesthesia department,Faculty of medicine, Mansoura univerisety | Recruiting |
Mansoura, Dakahlia, Egypt | |
Contact: mohamed ghanem, a.prof 00201067883998 mohamed.abdel_latif@yahoo.com |
Study Chair: | mohamed ghanem | Mansoura Faculty of Medicine-Mansoura University |
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: | September 4, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neuraxial opioids, post-operative itching, intrathecal Fentanyl pruritus, Spinal anesthesia |
Pruritus Skin Diseases Skin Manifestations 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 |