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Clinical Trials/NCT04490122
NCT04490122
Unknown
Not Applicable

Impact of Mode of Anesthesia on Ischemia Modified Albumin (Abiomarker of Oxidative Stress) and Outcome in Patients With Traumatic Brain Injury Undergoing Emergency Craniotomy

Abd-elrahman hassan abd -elaziz0 sites54 target enrollmentJuly 23, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oxidative Stress
Sponsor
Abd-elrahman hassan abd -elaziz
Enrollment
54
Primary Endpoint
ischemia modified albumin
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 23, 2020
End Date
October 30, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Abd-elrahman hassan abd -elaziz
Responsible Party
Sponsor Investigator
Principal Investigator

Abd-elrahman hassan abd -elaziz

Minia University Hospital

Minia University

Eligibility Criteria

Inclusion Criteria

  • Age 18-60 years old of both sex .
  • Isolated traumatic brain injury undergoing emergency craniotomy.
  • G.C.S more than
  • ASA grade (I-III).

Exclusion Criteria

  • Non traumatic brain injury.
  • Poly trauma patient.
  • Coagulation disorder.
  • Drug( alcohol, opiods, tranquilizers) addiction.
  • Liver and kidney dysfunction.
  • Severe diseases such as severe hypertension, cardiovascular disease, malignant tumor, autoimmune disease, mental disorders.
  • Diabetes mellitus with poor blood glucose control.
  • Previous drug allergy.
  • Currently lactating.

Outcomes

Primary Outcomes

ischemia modified albumin

Time Frame: change from preoperative level of ischemia modified albumin at the first 24 hours postoperatively

Plasma Level of ischemia modified albumin

Glascow Coma Scale

Time Frame: 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 Outcomes

  • 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.)
  • Incidence of any complication.(up to 28 days)
  • I.C.U stay.(up to 28 days)
  • I.C.U admission(up to 28 days)
  • 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.)

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