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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04490122

Enrollment

Registered

2020-07-28

Start date

2020-07-23

Completion date

2021-10-30

Last updated

2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oxidative Stress

Keywords

Ischemia modified albumin, oxidative stress, traumatic brain injury

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
I.C.U admission	up to 28 days	intensive care unit admission
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
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

Contacts

Primary ContactAbdel-rahman Abdel-aziz

dr0abdohassan88@yahoo.com01061812701

Outcome results