NCT03717467

Brief Summary

The aim of study is to assess the effect of intraoperative use of magnesium sulfate in liver donating patients in reducing post-operative morphine requirements in early postoperative 24 hour in adult living liver donor.The authors hypothesize that magnesium sulfate can be used to efficiently reduce postoperative morphine consumption in the early 24 hours postoperatively as evident in other surgery types.

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
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable postoperative-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

May 8, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

October 22, 2018

Last Update Submit

November 5, 2020

Conditions

Postoperative Pain

Keywords

Magnesium sulfateMorphine requirementHepatotomyOrthotopic liver transplantation

Outcome Measures

Primary Outcomes (1)

  • Postoperative Morphine consumption

    in mg

    24 hours after operation

Secondary Outcomes (49)

  • Mean arterial pressure

    1 minute before induction

  • Heart rate

    1 minute before induction

  • Mean arterial pressure

    30 seconds before intubation

  • Heart rate

    30 seconds before intubation

  • Mean arterial pressure

    5 minutes after beginning of surgery

  • +44 more secondary outcomes

Other Outcomes (6)

  • Age

    1 hour before operation once patient is recruited

  • Height

    1 hour before operation once patient is recruited

  • Weight

    1 hour before operation once patient is recruited

  • +3 more other outcomes

Study Arms (2)

S group

PLACEBO COMPARATOR

Isotonic saline as placebo will be given.

Drug: isotonic saline

M group

ACTIVE COMPARATOR

Magnesium sulfate will be given

Drug: Magnesium Sulfate

Interventions

isotonic salineDRUG

100 ml of isotonic saline over 15 min immediately before induction of anesthesia and then 15 mg/kg/h by continuous I.V. infusion until the end of operation.

Also known as: Saline group
S group
Magnesium SulfateDRUG

40 mg/kg of magnesium sulfate in 100 ml of isotonic saline over 15 min immediately before induction of anesthesia and then 15 mg/kg/h by continuous I.V. infusion until the end of operation.

Also known as: Magnesium group
M group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age (18-50).
  • American Society of Anesthesiology (ASA) physical state I or II.
  • Normal serum electrolytes.

You may not qualify if:

  • Impaired hepatic or renal functions.
  • Various degree of heart block.
  • Hypertension
  • Diabetes
  • Myopathy or any neurological disorder.
  • History of long term opioid use
  • Patients treated with calcium channel blockers
  • Patients with known allergy to drug used.
  • Pregnant woman
  • Obesity (Body Mass Index \> 30).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zayed hospital

Giza, 12573, Egypt

RECRUITING

Related Publications (5)

  • Gucyetmez B, Atalan HK, Aslan S, Yazar S, Polat KY. Effects of Intraoperative Magnesium Sulfate Administration on Postoperative Tramadol Requirement in Liver Transplantation: A Prospective, Double-Blind Study. Transplant Proc. 2016 Oct;48(8):2742-2746. doi: 10.1016/j.transproceed.2016.08.033.

    PMID: 27788811BACKGROUND

  • Demiroglu M, Un C, Ornek DH, Kici O, Yildirim AE, Horasanli E, Baskan S, Fikir E, Gamli M, Dikmen B. The Effect of Systemic and Regional Use of Magnesium Sulfate on Postoperative Tramadol Consumption in Lumbar Disc Surgery. Biomed Res Int. 2016;2016:3216246. doi: 10.1155/2016/3216246. Epub 2016 Jan 28.

    PMID: 27022607BACKGROUND

  • Sousa AM, Rosado GM, Neto Jde S, Guimaraes GM, Ashmawi HA. Magnesium sulfate improves postoperative analgesia in laparoscopic gynecologic surgeries: a double-blind randomized controlled trial. J Clin Anesth. 2016 Nov;34:379-84. doi: 10.1016/j.jclinane.2016.05.006. Epub 2016 Jun 5.

    PMID: 27687417BACKGROUND

  • Yassin HM, Abd Elmoneim AT, El Moutaz H. The Analgesic Efficiency of Ultrasound-Guided Rectus Sheath Analgesia Compared with Low Thoracic Epidural Analgesia After Elective Abdominal Surgery with a Midline Incision: A Prospective Randomized Controlled Trial. Anesth Pain Med. 2017 Jun 10;7(3):e14244. doi: 10.5812/aapm.14244. eCollection 2017 Jun.

    PMID: 28856110BACKGROUND

  • Karbasy SH, Derakhshan P. Effects of opium addiction on level of sensory block in spinal anesthesia with bupivacaine for lower abdomen and limb surgery: a case-control study. Anesth Pain Med. 2014 Nov 26;4(5):e21571. doi: 10.5812/aapm.21571. eCollection 2014 Dec.

    PMID: 25798378BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium ChlorideMagnesium Sulfate

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsMagnesium CompoundsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Mostafa S Elhamamsy, MD

    Faculty of medicine, Fayoum University

    STUDY CHAIR

  • Ahmed M Yassin, MD

    Faculty of medicine, Beni-suef University

    STUDY DIRECTOR

  • Abeer S Goda, MD

    Faculty of medicine, Fayoum University

    STUDY DIRECTOR

  • Hany M Yassin, MD

    Faculty of medicine, Fayoum University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed A Lotfy, M.Sc.

CONTACT

1068061357lotfy_23@yahoo.com

Hany M Yassin, MD

CONTACT

1023912463hmy00@fayoum.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Patient will be randomly assigned to one of the two groups. An independent anesthesiologist who will not be participating in the study prepares the study medications.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of anesthesia

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

May 8, 2019

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)