Impact of Mode of Anesthesia on Ischemia Modified Albumin in Patients With Traumatic Brain Injury

NCT ID: NCT04490122

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-23

Study Completion Date

2021-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Oxidative Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inhalational

will receive inhalational anesthesia

No interventions assigned to this group

Total intravenous

will receive total intravenous anesthesia with propofol infusion(100-150 mcg/kg/min) and dexmedetomedine 0.3mcg/kg/h.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age 18-60 years old of both sex .
2. Isolated traumatic brain injury undergoing emergency craniotomy.
3. G.C.S more than 8.
4. ASA grade (I-III).

Exclusion Criteria

1. Non traumatic brain injury.
2. Poly trauma patient.
3. Coagulation disorder.
4. Drug( alcohol, opiods, tranquilizers) addiction.
5. Liver and kidney dysfunction.
6. Severe diseases such as severe hypertension, cardiovascular disease, malignant tumor, autoimmune disease, mental disorders.
7. Diabetes mellitus with poor blood glucose control.
8. Previous drug allergy.
9. Currently lactating.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abd-elrahman hassan abd -elaziz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abd-elrahman hassan abd -elaziz

Minia University Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmed K Mohamed, professor

Role: PRINCIPAL_INVESTIGATOR

Minia University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Abdel-rahman Abdel-aziz

Role: CONTACT

01061812701

Related Links

Access external resources that provide additional context or updates about the study.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4771225/

Decompressive craniectomy and traumatic brain injury: a review.

https://www.ncbi.nlm.nih.gov/pubmed/31664468

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 trial

https://www.ncbi.nlm.nih.gov/pubmed/24527444

The comparison of the effects of sevoflurane inhalation anesthesia and intravenous propofol anesthesia on oxidative stress in one lung ventilation.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

374

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.