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Status unknownNCT03566329Updated Aug 15, 2019

Magnesium Sulphate Versus Lidocaine for Control of Emergence Hypertension

A Phase 1 interventional study of Magnesium sulphate and Lidocaine Hydrochloride in Craniotomy and Hypertension, sponsored by Ahmed Mohamed ELbadawy. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-08-15.

Sponsored by Ahmed Mohamed ELbadawy · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Post-craniotomy emergence hypertension is a common phenomenon that may predispose to development of intracranial hematoma and cerebral edema.The aim of this study is to compare the safety and efficacy of Mgso4 versus lidocaine infusion for control of emergence hypertension after craniotomy.

02

Conditions studied

  • Craniotomy
  • Hypertension

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Keywords

  • craniotomy- Emergence- hypertension
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 90 is close to the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Ahmed Mohamed ELbadawy is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ι or Π.
  • scheduled patients for brain tumor excision.

Exclusion criteria

Exclusion Criteria:

  • Hepatic, renal, cardiac, pulmonary, or endocrine impairment.
  • Signs of increased intracranial pressure or allergy to any of the used drugs.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Magnesium sulphate

    50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion

    Drug: Magnesium sulphate

  • Active comparator
    lidocaine hydrochloride

    1.5mg/kg loading followed by 2mg/kg/hr infusion

    Drug: Lidocaine Hydrochloride

  • Placebo comparator
    NaCl 0.9% normal saline

    Normal saline infusion with the same rate as the study drugs

    Drug: Normal saline

Interventions

  • DrugMagnesium sulphate

    Magnesium sulphate 50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion. .

  • DrugLidocaine Hydrochloride

    lidocaine hydrochloride 1.5mg/kg loading followed by 2mg/kg/hr infusion

    Also known as: Xylocaine

  • DrugNormal saline

    Normal saline infusion with the same rate of infusion as the study drugs

    Also known as: Nacl

06

What researchers measure

Primary outcomes

  1. postcraniotomy emergence hypertension response to the study drugs

    The number of the patients who have systolic blood pressure below 140 mmH during emergence of anesthesia after craniotomy for brain tumors in each group

    Time frame: 4hours

Secondary outcomes

  1. Recovery time

    Time till discharge from PACU

    Time frame: 2 hours

  2. Incidence of side effects of the used drugs

    measure of safety

    Time frame: 4 hours

07

Study locations

1 of 1 sites recruiting
  • Ahmed ELbadawy
    Cairo, 02, Egypt
    Recruiting
    • Ahmed ELbadawy · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2018 (actual). Primary completion is estimated for Dec 2019, 17 months after the start.

Of 44 non-industry phase 1 interventional studies under Hypertension, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12. This study's planned 17 months is below that.

Counting every sponsor, half of 175 studies reached it within 4 months; a quarter within 1 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2018
First posted
Jun 25, 2018
StartActual
Jul 10, 2018
Primary completionEst.
Dec 2019
CompletionEst.
Dec 2019
Last update
Aug 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03566329
Lead sponsor
Ahmed Mohamed ELbadawy
Responsible party
Ahmed Mohamed ELbadawy (Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University, Kasr El Aini Hospital) — Sponsor-investigator
First posted
Jun 25, 2018
Start date
Jul 10, 2018
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Aug 15, 2019

Study contacts

Ahmed ELbadawy, MD
Contact
elbadawyahmed89@yahoo.com
01064249076 ext. 11562
Ahmed ELbadawy, MD
principal investigator · Faculty of medicine- Cairo University- Egypt

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Magnesium Sulfate · Lidocaine

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Ahmed Mohamed ELbadawy

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