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

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

Study Overview

• Status: Unknown
• Conditions: Oxidative Stress

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 Type: Observational
• Enrollment (Anticipated): 54

Contacts and Locations

• Study Contact: Name: Abdel-rahman Abdel-aziz; Phone Number: 01061812701; Email: dr0abdohassan88@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ischemia modified albumin	Plasma Level of ischemia modified albumin	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)	change from preoperative Glascow Coma Scale score at the first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
I.C.U admission	intensive care unit admission	up to 28 days
I.C.U stay.	Length of stay in intensive care unit	up to 28 days
Incidence of any complication.	Incidence of any complication (nausea, vomiting, convulsion and reopening).	up to 28 days

Collaborators and Investigators

• Sponsor: Abd-elrahman hassan abd -elaziz
• Investigators: Principal Investigator: Ahmed K Mohamed, professor, Minia University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Anticipated): July 23, 2020
• Primary Completion (Anticipated): July 28, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: traumatic brain injury; oxidative stress; Ischemia modified albumin
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Ischemia; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No