Clinical trial NCT04490122: Impact of Mode of Anesthesia on Ischemia Modified Albumin in Patients With Traumatic Brain Injury
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oxidative Stress
Keywords: Ischemia modified albumin
oxidative stress
traumatic brain injury
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ischemia modified albumin
timeFrame: change from preoperative level of ischemia modified albumin at the first 24 hours postoperatively
measure: Glascow Coma Scale
timeFrame: change from preoperative Glascow Coma Scale score at the first 24 hours postoperatively
Secondary outcomes:
measure: Intraoperative blood pressure.
timeFrame: preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.
measure: Intraoperative heart rate
timeFrame: preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.
measure: I.C.U admission
timeFrame: up to 28 days
measure: I.C.U stay.
timeFrame: up to 28 days
measure: Incidence of any complication.
timeFrame: up to 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Minia University
name: Ahmed K Mohamed, professor
role: PRINCIPAL_INVESTIGATOR
References: