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

• Conditions: Oxidative Stress

• Registration Number: NCT04490122
• Lead Sponsor: Abd-elrahman hassan abd -elaziz

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-23
• Study Start: 2020-07-23
• Study First Submitted QC: 2020-07-24
• Last Update Submitted: 2020-07-24
• Study First Posted: 2020-07-28
• Last Update Posted: 2020-07-28
• Primary Completion: 2021-07-28
• Study Completion: 2021-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ischemia modified albumin	change from preoperative level of ischemia modified albumin at the first 24 hours postoperatively	Plasma Level of ischemia modified albumin
Glascow Coma Scale	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)

Secondary Outcome Measures

Name	Time	Method
Intraoperative blood pressure.	preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.	Intraoperative haemodynamics (Systolic blood pressure in millimeter mercury, diastolic blood pressure in millimeter mercury. Mean arterial blood pressure in millimeter mercury.
Incidence of any complication.	up to 28 days	Incidence of any complication (nausea, vomiting, convulsion and reopening).
I.C.U stay.	up to 28 days	Length of stay in intensive care unit
I.C.U admission	up to 28 days	intensive care unit admission
Intraoperative heart rate	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 per minute