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Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol For Chronic Subdural Hematoma

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ClinicalTrials.gov Identifier: NCT04621526
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Alshaimaa Abdel Fattah Kamel, Zagazig University

Tracking Information
First Submitted Date  ICMJE October 28, 2020
First Posted Date  ICMJE November 9, 2020
Last Update Posted Date December 22, 2020
Actual Study Start Date  ICMJE November 10, 2020
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
The onset time of sedation [ Time Frame: with in 30 minutes before start of surgery ]
The onset of sedation will be recorded. It is defined as the time from injection of sedative medications till reaching a target sedation level score 3 by modified Observer's Assessment of Alertness and sedation score (OAA/S).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
  • The extent of airway obstruction [ Time Frame: intraopertive ]
    The extent of airway obstruction by (1= patent airway, 2= airway obstruction alleviated by jaw thrust, 3= airway obstruction alleviated by positive mask ventilation)
  • rescue analgesic (fentanyl) [ Time Frame: intraoperative ]
    Total number of calling intraoperative rescue analgesic (fentanyl) in both groups will be recorded.
  • number of participant with complications [ Time Frame: intraoperative ]
    Intraoperative complications such as hypotension (mean arterial blood pressure decreases by > 20% of basal reading), bradycardia (HR decreases by > 20% of basal reading) and bradypnea (RR less than 10 b/m) or hypoxemia (SpO2 less than 95%
  • Recovery time [ Time Frame: with in one hour postoperative ]
    Recovery time: time from discontinuation of infusion drugs till spontaneous eye opening.
  • Postoperative Pain intensity [ Time Frame: at 30 minutes then at 1, 2, 4, 6 and 12 hours postoperative ]
    Postoperative Pain intensity will be evaluated using Visual Analogue Scale (VAS) . A commonly used scale is a 10-cm line labeled with "worst pain imaginable" on the left border and "no pain" on the right border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. It will be assessed at 30 minutes, 2h, 4h and 6h till 12h postoperative. Paracetamol 1gm IV will be given every 6 hours as a protocol for pain management, and IV pethidine 50 mg (rescue analgesic) will be given if VAS≥4.
  • The Neurological status of participants [ Time Frame: at baseline then within one hour postoperative ]
    The Neurological status of participants will be assessed before discharge in the PACU using Markwalder's Neurological Grading scale (MNGs) and recorded: Grade 0: no neurologic deficit Grade I: mild symptoms such as headache; absent or mild neurologic deficits such as reflex asymmetry Grade II: drowsiness or disorientation with variable neurologic deficits such as hemiparesis Grade III: stupor, but appropriate responses to noxious stimuli; severe focal signs such as hemiplegia Grade IV: coma with absence of motor response to painful stimuli; decerebrate or decorticate posturing.
  • Patient and surgeon satisfaction [ Time Frame: with in 24 hours after surgery ]
    Patient and surgeon satisfaction using 7- point Likert-like verbal rating scale by asking about how they evaluate their experience with anesthetic management during surgery?" score will be 6 and 7 if they are satisfied.5=very satisfied, 4=satisfied, 3= neutral, 2= unsatisfied and 1= very unsatisfied.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol For Chronic Subdural Hematoma
Official Title  ICMJE Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol Combination During Burr-Hole Surgery For Chronic Subdural Hematoma
Brief Summary

Inadequate sedation and analgesia indicated by intraoperative movements are markers of inadequate MAC during burr-hole surgery for chronic subdural hematoma evacuation especially when general anesthesia poses high risk for the patients.

Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to provide monitored anesthesia care with variable success if used as solitary agents as each drug has its limited use.

Detailed Description Sample size: Assuming that the mean ± SD of the onset time of sedation was 50.2±4.9 seconds in propofol group versus 53.8±6.1 seconds in dexmedetomidine-propofol group (9). So the total sample size is 76 cases (38 in each group) using Open Epi Info with confidence interval 95% and power of test is 80%.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Conscious Sedation
Intervention  ICMJE
  • Drug: dexmedetomidine- ketamine
    patients will receive combination of ketamine 1.5mg/kg and dexmedetomidine 0.5ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and ketamine 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
    Other Name: precedex- katalar
  • Drug: dexmedetomidine- propofol
    patients will receive combination from 1 mg/kg propofol and dexmedetomidine 0.5ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and propofol 1 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
    Other Name: precedex- diprivan
Study Arms  ICMJE
  • Active Comparator: dexmedetomidine- ketamine
    patients will receive combination of ketamine 1.5mg/kg and dexmedetomidine 0.5ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and ketamine 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
    Intervention: Drug: dexmedetomidine- ketamine
  • Active Comparator: dexmedetomidine- propofol
    patients will receive combination from 1 mg/kg propofol and dexmedetomidine 0.5ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and propofol 1 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
    Intervention: Drug: dexmedetomidine- propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2020)
76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient acceptance.
  • Both sex.
  • Age (50-80) years old.
  • Patient with Body Mass Index (BMI) (25-30kg/m²).
  • American Society of Anesthesiologist (ASA) II / III
  • patient scheduled to burr-hole surgery for chronic subdural hematoma evacuation under MAC.
  • Markwalder's Neurological Grading scale (MNGs) score <2.

Exclusion Criteria:

  • Patient with difficult airway (mallapati III,IV).
  • Altered mental status (psychiatric and anexity disorder).
  • Post-traumatic stress disorders.
  • History of allergy to study drugs.
  • Patient on sedative or hypnotic medication.
  • Patients with on painkiller.
  • Patients with any degree of heart block.
  • Sever liver, respiratory or renal impairment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alshaimaa Kamel, M.D 01005593169 ext 002 AlshaimaaKamel80@yahoo.com
Contact: Salwa ElSherbeny, M.D 01128595629 ext 002
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04621526
Other Study ID Numbers  ICMJE 6434
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alshaimaa Abdel Fattah Kamel, Zagazig University
Study Sponsor  ICMJE Zagazig University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alshaimaa Kamel, M.D Zagazig University
PRS Account Zagazig University
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP