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

Oxidative Stress Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04490122
• Other study ID #: 374
• Status: Not yet recruiting
• Start date: July 23, 2020
• Est. completion date: October 30, 2021

Study information

• Verified date: February 2020
• Source: Minia University
• Contact: Abdel-rahman Abdel-aziz
• Phone: 01061812701
• Email: dr0abdohassan88[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: October 30, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Ischemia
• Oxidative Stress

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abd-elrahman hassan abd -elaziz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ischemia modified albumin	Plasma Level of ischemia modified albumin	change from preoperative level of ischemia modified albumin at the first 24 hours postoperatively
Primary	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)	change from preoperative Glascow Coma Scale score at the first 24 hours postoperatively
Secondary	Intraoperative blood pressure.	Intraoperative haemodynamics (Systolic blood pressure in millimeter mercury, diastolic blood pressure in millimeter mercury. Mean arterial blood pressure in millimeter mercury.	preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.
Secondary	Intraoperative heart rate	Intraoperative heart rate per minute	preoperatively, immediatly after intubation,after 5 minutes,afer 15 minutes,after 30 minutes,after 60 minutes,after 90 minutes and immediatly after extubation.
Secondary	I.C.U admission	intensive care unit admission	up to 28 days
Secondary	I.C.U stay.	Length of stay in intensive care unit	up to 28 days
Secondary	Incidence of any complication.	Incidence of any complication (nausea, vomiting, convulsion and reopening).	up to 28 days

External Links

•   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
•   Decompressive craniectomy and traumatic brain injury: a review.
•   The comparison of the effects of sevoflurane inhalation anesthesia and intravenous propofol anesthesia on oxidative stress in one lung ventilation.