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Opioid Free VS Opioid Anesthesia for Craniotomies

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ClinicalTrials.gov Identifier: NCT04941040
Recruitment Status : Not yet recruiting
First Posted : June 28, 2021
Last Update Posted : June 28, 2021
Sponsor:
Information provided by (Responsible Party):
Rania Samir Fahmy, Kasr El Aini Hospital

Brief Summary:
Hemodynamic control during craniotomies can be a bit hectic specially during periods of intense noxious stimulation. For long anesthesiologists used high doses of opioids such as fentanyl and remifentanyl to provide analgesia with a good hemodynamic control during intraoperative period in patients undergoing craniotomies. However, the use of opioids was not devoid of side effects. Exploring other anesthetic plans using multiple opioid free anesthetic adjuvants that have analgesic effects given together in small doses appear to be appealing plan. This idea is the basis of our proposed study in which we compare the hemodynamic effects of using opioid free anesthesia versus opioid anesthesia in cranial surgeries.

Condition or disease Intervention/treatment Phase
Supratentorial Neoplasms Drug: Opioid free anesthetics Drug: Opioid Anesthetics Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Hemodynamic Effects of Opioid Free Anesthesia Versus Opioid Anesthesia on Adult Patients Undergoing Craniotomies for Supratentorial Tumors. Randomized Controlled Trial
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: Opioid free anesthesia
patients are going to receive intraoperative analgesics other than opioids
Drug: Opioid free anesthetics

Patients will receive over the 10 minutes prior to induction:

  • Acetaminophen 1 gm i.v. infusion in 100ml over 10 minutes.
  • Ketorolac 30 mg i.v. infusion in100 ml over 10 minutes.
  • Mg SO4 loading dose 30 mg/kg i.v. infusion in 100 ml over 10 minutes.
  • Dexmedetomidine loading dose 1 μg/kg i.v. infusion.
  • Lidocaine loading dose 1.5 mg/kg i.v. infusion.
  • Ketamine loading dose 0.25 mg/kg i.v. infusion.

The weight based doses of dexmedetomidine, lidocaine, ketamine will be prepared on 20 ml syringe and infused over 10 minutes prior to induction. In a dose of 0.1 ml/kg

Then after induction maintenance analgesic infusion will start in a rate that ranges from 0.025 to 0.05 ml/kg/h which is equivalent to:

  • Dexmedetomidine 0.25-0.5 μg/kg/h
  • Lidocaine 0.375-0.75 mg/kg/h
  • Ketamine 0.0625- 0.125 mg/kg/h
Other Name: OFA

Active Comparator: Opioid anesthesia
patients are going to receive intraoperative opioid analgesics
Drug: Opioid Anesthetics
Placebo equivalent to acetaminophen, ketorolac, magnesium sulphate will be infused as 100 ml normal saline each over 10 minutes ,patients will receive fentanyl 2 μg/kg loading dose which will be prepared over 20 ml syringe and infused over 10 minutes prior to induction, Then after induction maintenance of analgesic infusion by fentanyl 0.5-1 μg/kg/h.
Other Name: OA




Primary Outcome Measures :
  1. Percentage of patients experiencing a change in mean arterial pressure at time of Burr Hole [ Time Frame: During Burr hole surgery ]
    Defined as recording an increase or decrease of the mean arterial blood pressure by more than 25 % from baseline readings at the time of burr hole


Secondary Outcome Measures :
  1. HR (heart rate) in beats/min [ Time Frame: Baseline, pre-induction, pre-intubation, after intubation, skin incision, burr hole, dural incision, dural closure, skin closure, every 30 minutes intraoperative till extubation, time of extubation, every 15 minutes for 2 hours in PACU. ]
    Hemodynamic parameter recorded during the study

  2. Brain relaxation score [ Time Frame: At the time of dural incision ]
    Defined as 1= excellently relaxed, 2= satisfactory relaxed, 3= leveled, 4=bulging

  3. Number of patients requiring antihypertensive medication [ Time Frame: Throughout the operation ]
    Number of patients needing nitroglycerine infusion in each group was recorded together with total amount infused

  4. Number of patients requiring medication to increase blood pressure [ Time Frame: Throughout the operation ]
    Number of patients needing ephedrine in each group was recorded together with total amount infused.

  5. Time to extubation [ Time Frame: At the end of the operation, the time from the discontinuation of inhalation agents till extubation ]
    Defined as the time between the discontinuation of inhalation agents and extubation

  6. Ramsay Sedation Scale (RSS) [ Time Frame: every 30 minutes for 2 hours postoperative ]
    to assess the postoperative sedation, it is a scale from 1 to 6. It provides three levels of 'awake' states (score 1-3) and three levels of 'asleep' states (score 4-6). A score of 2 (patient is cooperative, orientated and tranquil)

  7. Systolic blood pressure (SBP) in mmhg [ Time Frame: Baseline, pre-induction, pre-intubation, after intubation, skin incision, burr hole, dural incision, dural closure, skin closure, every 30 minutes intraoperative till extubation, time of extubation, every 15 minutes for 2 hours in PACU. ]
    Hemodynamic parameter recorded during the study

  8. Mean arterial blood pressure (MAP) in mmhg [ Time Frame: Baseline, pre-induction, pre-intubation, after intubation, skin incision, burr hole, dural incision, dural closure, skin closure, every 30 minutes intraoperative till extubation, time of extubation, every 15 minutes for 2 hours in PACU. ]
    Hemodynamic parameter recorded during the study



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA Ι and II.
  • Patients undergoing surgeries for removal of supratentorial tumors.
  • Age (18-60) years.
  • Both sexes.

Exclusion Criteria:

  • Impaired renal functions.
  • Systemic hypertension.
  • Dysrhythmia.
  • Heart failure.
  • Glasgow coma scale less than 12.
  • The need for postoperative ventilation.
  • History of allergy to the study drugs.
  • Surgeries lasting more than 6 hours.
  • Pregnancy.
  • Bronchial asthma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04941040


Contacts
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Contact: Rania S Fahmy 01270820372 ransam98@gmail.com

Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Rania S Fahmy Kasr Al Ainy, Faculty of medicine, Cairo university
Publications:

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Responsible Party: Rania Samir Fahmy, Assistant professor of Anesthesia, ICU and pain medicine, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT04941040    
Other Study ID Numbers: N 56-2016/MD
First Posted: June 28, 2021    Key Record Dates
Last Update Posted: June 28, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rania Samir Fahmy, Kasr El Aini Hospital:
Opioid free Anesthesia
Craniotomies
Dexmedetomidine
Ketamine
Fentanyl
Lidocaine
Magnesium sulphate
supratentorial tumors
Additional relevant MeSH terms:
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Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Central Nervous System Diseases
Central Nervous System Depressants
Brain Diseases
Nervous System Diseases
Analgesics, Opioid
Anesthetics
Physiological Effects of Drugs
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents