Supratentorial Brain TumorPhase 4NCT03318471
Magnesium Sulphate for Attenuation of Hemodynamic Pressor Response After Myfield's Clamp Application
A Phase 4 study testing MgSo4 and 0.9% NaCl in people with Supratentorial Brain Tumor, run by El-Sahel Teaching Hospital.
Trial summary
Use of Mayfield skull clamp during craniotomies; results in a sharp and intense noxious stimulus which results in a severe hemodynamic pressor response. Many strategies have been reported to blunt this undesirable pressor effect. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Supratentorial Brain Tumor
- What is being tested?
- MgSo4 and 0.9% NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to 1 Oct 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All adult patients aged from 18 to 60 years
- of both genders
- ASA physical status I and II
- scheduled for craniotomies
Who cannot join
- history of MgSo4 consumption or allergy
- renal disease
- hepatic or endocrine disorder
- cardiovascular dysfunction
- calcium channel blocker intake
- drug abuse were excluded from this study.
About this study
Official title: The Effect of Intravenous Single Dose of Magnesium Sulphate on Attenuation of Hemodynamic Pressor Response After Myfield's Clamp Application During Craniotomies
Use of Mayfield skull clamp during craniotomies; results in a sharp and intense noxious stimulus which results in a severe hemodynamic pressor response. Many strategies have been reported to blunt this undesirable pressor effect. This prospective, double blind, and randomized study is the first to evaluate the effect of MgSo4 on attenuation of hemodynamic pressor activity after head clamp application during craniotomies.
Read the detailed description
Background: Use of Mayfield skull clamp during craniotomies; results in a sharp and intense noxious stimulus which results in a severe hemodynamic pressor response. Many strategies have been reported to blunt this undesirable pressor effect. This prospective, double blind, and randomized study is the first to evaluate the effect of MgSo4 on attenuation of hemodynamic pressor activity after head clamp application during craniotomies.
Methods: This randomized, double blind, and prospective study was done in Neurosurgical department at ElSahel Teaching Hospital in Cairo from February 2016 till august 2017. All adult patients aged from 18 to 60 years of both genders, ASA physical status I and II scheduled for craniotomies were assessed to enter this study. Seventy one patients were assessed preoperatively, sixty of them were enrolled and assigned in two groups (n=30 each). Group M received 50 mg/kg MgSo4 in 100 ml 0.9 sodium Chloride 15 minutes prior to anesthesia induction over 15 minutes. Group S received 100ml 0.9% Sodium Chloride over the same period with the same rate.Mean HR was recorded as a primary outcome , meanwhile; MAP and the need for a bolus dose of fentanyl was considered a secondary outcome.
- Conditions
- Supratentorial Brain Tumor
- Being tested
- MgSo4, 0.9% NaCl
- Keywords
- MgSo4, Mayfield clamp, pressor effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MgSo4Drug
Also called magnesium sulphate
50 mg/kg MgSo4 in 100 ml 0.9 sodium Chloride 15 minutes prior to anesthesia induction over 15 minutes
0.9% NaClDrug
Also called normal saline
100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group M | Active comparator | received 50 mg/kg MgSo4 in 100 ml 0.9 NaCl 15 minutes prior to anesthesia induction over 15 minutes Receives: Drug: MgSo4 |
| Group S | Placebo comparator | received 100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes. Receives: Drug: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean HR
Mean heart rate/min.
Measured: From time of insertion over 30 minutes period {at the time of pins insertion (Pin 0),60 seconds ( pin 60'), 5 minutes (pin 5''), 10 minutes ( pin 10''), 20 minutes ( pin 20'') and 30 minutes (pin 30'').}
Secondary outcomes (2)
MAP
Mean arterial Blood Pressure (mmHg)
Measured: From time of insertion over 30 minutes period {at the time of pins insertion (Pin 0),60 seconds ( pin 60'), 5 minutes (pin 5''), 10 minutes ( pin 10''), 20 minutes ( pin 20'') and 30 minutes (pin 30'').}
Need for a bolus opioid
Need for a bolus fentanyl after pins insertion to alleviate pressor effects
Measured: from time of insertion over 30 minutes .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study startFeb 2016
- Primary completionAug 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Supratentorial Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- El-Sahel Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Samir Ahmed Ahmed ElKafrawy, El-Sahel Teaching Hospital
- Investigators
- Samir A ElKafrawy, MD, Principal investigator, ElSahel Teaching hospital,Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318471
- Sponsor's protocol ID
- 2017101
- Status last verified
- Oct 2017
- First submitted
- 14 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1. Gonzales RM, Masone RJ, Peterson R. Hemodynamic response to application of neurosurgical skull-pin head-holder. Anesth Rev. 1987; 14:53-4.
Bithal PK, Dash HH, Chauhan R, Mohanty B. Haemodynamic changes in response to skull-pins application - Comparison between normotensive and hypertensive patients. Indian J Anaesth. 2002; 46:383-5.
Paul A, Krishna HM. Comparison between intravenous dexmedetomidine and local lignocaine infiltration to attenuate the haemodynamic response to skull pin head holder application during craniotomy. Indian J Anaesth. 2015 Dec;59(12):785-8. doi: 10.4103/0019-5049.171558.
PubMed 26903671Osborn I, Sebeo J. "Scalp block" during craniotomy: a classic technique revisited. J Neurosurg Anesthesiol. 2010 Jul;22(3):187-94. doi: 10.1097/ANA.0b013e3181d48846.
PubMed 20479675
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Single Dose of Magnesium Sulphate on Attenuation of Hemodynamic Pressor Response After Myfield's Clamp Application During Craniotomies
- ClinicalTrials.gov ID
- NCT03318471
- Acronym / sponsor ID
- 2017101
- Conditions
- Supratentorial Brain Tumor
- Keywords
- MgSo4, Mayfield clamp, pressor effect
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- El-Sahel Teaching HospitalOther government
- Study start
- Feb 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Use of Mayfield skull clamp during craniotomies; results in a sharp and intense noxious stimulus which results in a severe hemodynamic pressor response. Many strategies have been reported to blunt this undesirable pressor effect. This prospective, double blind, and randomized study is the first to evaluate the effect of MgSo4 on attenuation of hemodynamic pressor activity after head clamp application during craniotomies.
Detailed description
Background: Use of Mayfield skull clamp during craniotomies; results in a sharp and intense noxious stimulus which results in a severe hemodynamic pressor response. Many strategies have been reported to blunt this undesirable pressor effect. This prospective, double blind, and randomized study is the first to evaluate the effect of MgSo4 on attenuation of hemodynamic pressor activity after head clamp application during craniotomies.
Methods: This randomized, double blind, and prospective study was done in Neurosurgical department at ElSahel Teaching Hospital in Cairo from February 2016 till august 2017. All adult patients aged from 18 to 60 years of both genders, ASA physical status I and II scheduled for craniotomies were assessed to enter this study. Seventy one patients were assessed preoperatively, sixty of them were enrolled and assigned in two groups (n=30 each). Group M received 50 mg/kg MgSo4 in 100 ml 0.9 sodium Chloride 15 minutes prior to anesthesia induction over 15 minutes. Group S received 100ml 0.9% Sodium Chloride over the same period with the same rate.Mean HR was recorded as a primary outcome , meanwhile; MAP and the need for a bolus dose of fentanyl was considered a secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Drug: MgSo4received 50 mg/kg MgSo4 in 100 ml 0.9 NaCl 15 minutes prior to anesthesia induction over 15 minutes |
| Group S | Placebo comparator | Drug: 0.9% NaClreceived 100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All adult patients aged from 18 to 60 years
- of both genders
- ASA physical status I and II
- scheduled for craniotomies
Key exclusion criteria (6 listed)
- history of MgSo4 consumption or allergy
- renal disease
- hepatic or endocrine disorder
- cardiovascular dysfunction
- calcium channel blocker intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MgSo4Also: magnesium sulphate50 mg/kg MgSo4 in 100 ml 0.9 sodium Chloride 15 minutes prior to anesthesia induction over 15 minutes | Drug | Group M |
| 0.9% NaClAlso: normal saline100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes | Drug | Group S |
Primary outcome
Mean HR
Time frame: From time of insertion over 30 minutes period {at the time of pins insertion (Pin 0),60 seconds ( pin 60'), 5 minutes (pin 5''), 10 minutes ( pin 10''), 20 minutes ( pin 20'') and 30 minutes (pin 30'').}
Mean heart rate/min.
2 secondary outcomes
MAP
Time frame: From time of insertion over 30 minutes period {at the time of pins insertion (Pin 0),60 seconds ( pin 60'), 5 minutes (pin 5''), 10 minutes ( pin 10''), 20 minutes ( pin 20'') and 30 minutes (pin 30'').}
Need for a bolus opioid
Time frame: from time of insertion over 30 minutes .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Background1. Gonzales RM, Masone RJ, Peterson R. Hemodynamic response to application of neurosurgical skull-pin head-holder. Anesth Rev. 1987; 14:53-4.
- BackgroundBithal PK, Dash HH, Chauhan R, Mohanty B. Haemodynamic changes in response to skull-pins application - Comparison between normotensive and hypertensive patients. Indian J Anaesth. 2002; 46:383-5.
- Background: PubMed 26903671Paul A, Krishna HM. Comparison between intravenous dexmedetomidine and local lignocaine infiltration to attenuate the haemodynamic response to skull pin head holder application during craniotomy. Indian J Anaesth. 2015 Dec;59(12):785-8. doi: 10.4103/0019-5049.171558.
- Background: PubMed 20479675Osborn I, Sebeo J. "Scalp block" during craniotomy: a classic technique revisited. J Neurosurg Anesthesiol. 2010 Jul;22(3):187-94. doi: 10.1097/ANA.0b013e3181d48846.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir A ElKafrawy, MD principal investigator
ElSahel Teaching hospital,Cairo
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MgSo4 and 0.9% NaCl in people with Supratentorial Brain Tumor, run by El-Sahel Teaching Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean HR (time frame: From time of insertion over 30 minutes period {at the time of pins insertion (Pin 0),60 seconds ( pin 60'), 5 minutes (pin 5''), 10 minutes ( pin 10''), 20 minutes ( pin 20'') and 30 minutes (pin 30'').}). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318471, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.