Oxidative StressNCT04490122
Impact of Mode of Anesthesia on Ischemia Modified Albumin in Patients With Traumatic Brain Injury
An observational study of Oxidative Stress, run by Abd-elrahman hassan abd -elaziz.
Trial summary
In the current study the investigators intend to evaluate the mode of anesthesia on ischemia modified albumin and outcome in patients with traumatic brain injury undergoing emergency craniotomy Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Oxidative Stress
- Type of treatment
- Injection or infusion
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 23 Jul 2020to 30 Oct 2021
- Phase
- Observational
- 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
Study population: patients with traumatic brain injury, aged from 18- 60 years old, ASA from (I-III), GCS more than 8 undergoing emergency craniotomy surgery
Who may be able to join
- Age 18-60 years old of both sex .
- Isolated traumatic brain injury undergoing emergency craniotomy.
- G.C.S more than 8.
- ASA grade (I-III).
Who cannot join
- Non traumatic brain injury.
- Poly trauma patient.
- Coagulation disorder.
- Drug( alcohol, opiods, tranquilizers) addiction.
- Liver and kidney dysfunction.
- Severe diseases such as severe hypertension, cardiovascular disease, malignant tumor, autoimmune disease, mental disorders.
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- Diabetes mellitus with poor blood glucose control.
- Previous drug allergy.
- Currently lactating.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Mode of Anesthesia on Ischemia Modified Albumin (Abiomarker of Oxidative Stress) and Outcome in Patients With Traumatic Brain Injury Undergoing Emergency Craniotomy
In the current study the investigators intend to evaluate the mode of anesthesia on ischemia modified albumin and outcome in patients with traumatic brain injury undergoing emergency craniotomy
Read the detailed description
After obtaining Institutional Ethical Committee approval and written informed consent from legally acceptable representative relatives, patients with traumatic brain injury, aged from 18- 60 years old, ASA from (I-III), GCS more than 8 undergoing emergency craniotomy surgery will be selected for this prospective randomized Study.
The anesthesia will be induced with 2mcg/kg fentanyl and 2 mg/kg propofol. Muscle relaxation will be achieved with 0.5 mg/kg atracurium.
Anesthesia will be maintained with:
- Group I, isoflurane (mac<1) mixed with oxygen 40% and fentanyl 1mcg/kg hourly.
- Group PD, propofol infusion(100-150mcg/kg/min) and dexmedetomedine 0.3mcg/kg /h.
Parameters will be assessed Preoperative period
- Ischemia modified albumin level from venous sample.
- Basal Systolic blood pressure, diastolic blood pressure. Mean arterial blood pressure, oxygen saturation, heart rate.
- GCS. Intraoperative period
- Systolic blood pressure, diastolic blood pressure. Mean arterial blood pressure, oxygen saturation, heart rate after intubation, 5,15,30,60,90min and after extubation.
- Need for resuscitation with vasoactive drugs.
- Brain relaxation score at dural opening and closure.
- ICP
- Intraoperative blood loss.
- Amount of fluid and blood transfusion. Postoperative period
- Ischemia modified albumin immediately postoperatively, after 6h and after 24 hours.
- Type of surgery.
- Duration of surgery.
- Extubation time.
- Recovery scores (Ramsay sedation score and modified Alderte score).
- GCS immediately postoperatively, after 6h, after 24h and after 48 hours.
- Total analgesic requirement during the first 24 hours.
- Need for ICU admission.
- Length of ICU stay.
- Complications.
- 28 day mortality.
- Conditions
- Oxidative Stress
- Keywords
- Ischemia modified albumin, oxidative stress, traumatic brain injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inhalational | will receive inhalational anesthesia | |
| Total intravenous | will receive total intravenous anesthesia with propofol infusion(100-150 mcg/kg/min) and dexmedetomedine 0.3mcg/kg/h. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ischemia modified albumin
Plasma Level of ischemia modified albumin
Measured: change from preoperative level of ischemia modified albumin at the first 24 hours postoperatively
Glascow Coma Scale
Glascow Coma Scale records the state of a person's consciousness. it gives a person's score between 3 (indicating deep unconsciousness) and 15 (indicating fully consciousness)
Measured: change from preoperative Glascow Coma Scale score at the first 24 hours postoperatively
Secondary outcomes (5)
Intraoperative blood pressure.
Intraoperative haemodynamics (Systolic blood pressure in millimeter mercury, diastolic blood pressure in millimeter mercury. Mean arterial blood pressure in millimeter mercury.
Measured: preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.
Intraoperative heart rate
Intraoperative heart rate per minute
Measured: preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.
I.C.U admission
intensive care unit admission
Measured: up to 28 days
I.C.U stay.
Length of stay in intensive care unit
Measured: up to 28 days
Incidence of any complication.
Incidence of any complication (nausea, vomiting, convulsion and reopening).
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start23 Jul 2020 (estimated)
- Primary completion28 Jul 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abd-elrahman hassan abd -elaziz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abd-elrahman hassan abd -elaziz, Minia University
- Investigators
- Ahmed K Mohamed, professor, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490122
- Sponsor's protocol ID
- 374
- Status last verified
- Feb 2020
- First submitted
- 23 Feb 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mode of Anesthesia on Ischemia Modified Albumin (Abiomarker of Oxidative Stress) and Outcome in Patients With Traumatic Brain Injury Undergoing Emergency Craniotomy
- ClinicalTrials.gov ID
- NCT04490122
- Acronym / sponsor ID
- 374
- Conditions
- Oxidative Stress
- Keywords
- Ischemia modified albumin, oxidative stress, traumatic brain injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Abd-elrahman hassan abd -elazizUniversity, hospital or other
- Study start
- 23 Jul 2020 (estimated)
- Primary completion
- 28 Jul 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 28 Jul 2020 (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.
In the current study the investigators intend to evaluate the mode of anesthesia on ischemia modified albumin and outcome in patients with traumatic brain injury undergoing emergency craniotomy
Detailed description
After obtaining Institutional Ethical Committee approval and written informed consent from legally acceptable representative relatives, patients with traumatic brain injury, aged from 18- 60 years old, ASA from (I-III), GCS more than 8 undergoing emergency craniotomy surgery will be selected for this prospective randomized Study.
The anesthesia will be induced with 2mcg/kg fentanyl and 2 mg/kg propofol. Muscle relaxation will be achieved with 0.5 mg/kg atracurium.
Anesthesia will be maintained with:
- Group I, isoflurane (mac<1) mixed with oxygen 40% and fentanyl 1mcg/kg hourly.
- Group PD, propofol infusion(100-150mcg/kg/min) and dexmedetomedine 0.3mcg/kg /h.
Parameters will be assessed Preoperative period
- Ischemia modified albumin level from venous sample.
- Basal Systolic blood pressure, diastolic blood pressure. Mean arterial blood pressure, oxygen saturation, heart rate.
- GCS. Intraoperative period
- Systolic blood pressure, diastolic blood pressure. Mean arterial blood pressure, oxygen saturation, heart rate after intubation, 5,15,30,60,90min and after extubation.
- Need for resuscitation with vasoactive drugs.
- Brain relaxation score at dural opening and closure.
- ICP
- Intraoperative blood loss.
- Amount of fluid and blood transfusion. Postoperative period
- Ischemia modified albumin immediately postoperatively, after 6h and after 24 hours.
- Type of surgery.
- Duration of surgery.
- Extubation time.
- Recovery scores (Ramsay sedation score and modified Alderte score).
- GCS immediately postoperatively, after 6h, after 24h and after 48 hours.
- Total analgesic requirement during the first 24 hours.
- Need for ICU admission.
- Length of ICU stay.
- Complications.
- 28 day mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhalational | – | –will receive inhalational anesthesia |
| Total intravenous | – | –will receive total intravenous anesthesia with propofol infusion(100-150 mcg/kg/min) and dexmedetomedine 0.3mcg/kg/h. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with traumatic brain injury, aged from 18- 60 years old, ASA from (I-III), GCS more than 8 undergoing emergency craniotomy surgery
Key inclusion criteria (4 listed)
- Age 18-60 years old of both sex .
- Isolated traumatic brain injury undergoing emergency craniotomy.
- G.C.S more than 8.
- ASA grade (I-III).
Key exclusion criteria (9 listed)
- Non traumatic brain injury.
- Poly trauma patient.
- Coagulation disorder.
- Drug( alcohol, opiods, tranquilizers) addiction.
- Liver and kidney dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ischemia modified albumin
Time frame: change from preoperative level of ischemia modified albumin at the first 24 hours postoperatively
Plasma Level of ischemia modified albumin
Glascow Coma Scale
Time frame: change from preoperative Glascow Coma Scale score at the first 24 hours postoperatively
Glascow Coma Scale records the state of a person's consciousness. it gives a person's score between 3 (indicating deep unconsciousness) and 15 (indicating fully consciousness)
5 secondary outcomes
Intraoperative blood pressure.
Time frame: preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.
Intraoperative heart rate
Time frame: preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.
I.C.U admission
Time frame: up to 28 days
I.C.U stay.
Time frame: up to 28 days
Incidence of any complication.
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Decompressive craniectomy and traumatic brain injury: a review.Link provided by the sponsor.
- Comparison of total intravenous anesthesia vs. inhalational anesthesia on brain relaxation, intracranial pressure, and hemodynamics in patients with acute subdural hematoma undergoing emergency craniotomy: a randomized control trialLink provided by the sponsor.
- The comparison of the effects of sevoflurane inhalation anesthesia and intravenous propofol anesthesia on oxidative stress in one lung ventilation.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ahmed K Mohamed, professor principal investigator
Minia University
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress, run by Abd-elrahman hassan abd -elaziz.
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 9 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: status not confirmed, as of the sponsor's last update on 28 Jul 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdel-rahman Abdel-aziz (01061812701, dr0abdohassan88@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ischemia modified albumin (time frame: change from preoperative level of ischemia modified albumin at the first 24 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.