NCT04160598

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. 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. 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. 3.The incidence of PONV.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

November 9, 2019

Last Update Submit

September 2, 2020

Conditions

Magnesium Infusion in Post-spinal Opioid Pruritis

Keywords

Neuraxial opioids, post-operative itching, intrathecal Fentanyl pruritus, Spinal anesthesia

Outcome Measures

Primary Outcomes (1)

  • Incidence of pruritus in each group incidence %.

    Existence,Severity, Site of pruritus (Face (trigeminal) =1, neuraxial (dermatome) =2)

    during the 1st 6 hours after spinal fentanyl injection.

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

bolus 50 ml nacl 0.9% at the end of surgery over 20 minutes 5ml/minute infusion rate.

Drug: IV infusionDrug: intrathecal fentanyl

IV Mg ++ group

EXPERIMENTAL

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 infusionDrug: intrathecal fentanyl

Interventions

IV infusionDRUG

Control group (Placebo Group): bolus 50 ml Nacl 0.9% at the end of surgery over 20 minutes 5ml/minute infusion rate.

IV Mg ++ groupPlacebo group
intrathecal fentanylDRUG

10-15mg hyperbaric bupivacaine and 30µg fentanyl intrathecally injected

IV Mg ++ groupPlacebo group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesia department,Faculty of medicine, Mansoura univerisety

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Interventions

Infusions, Intravenous

Intervention Hierarchy (Ancestors)

Administration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, Parenteral

Study Officials

  • mohamed ghanem

    Mansoura Faculty of Medicine-Mansoura University

    STUDY CHAIR

Central Study Contacts

mohamed Ghanem, A.professor

CONTACT

00201067883998mohamed.abdel_latif@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor os anesthesia ICU & Pain medicine.

Study Record Dates

First Submitted

November 9, 2019

First Posted

November 13, 2019

Study Start

September 2, 2020

Primary Completion

March 20, 2021

Study Completion

March 30, 2021

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)