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Completed

NCT Number: NCT04621526

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

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.

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Key information

Conditions

Conscious Sedation

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Zagazig University Hospitsals

Zagazig, 055, Egypt

About this study

  • Null hypothesis (H0): There are no differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.
  • Alternative hypothesis (H1): There are differences between the effects of dexmedetomidine- ketamine and dexmedetomidine- propofol combination for monitored anesthesia care during burr-hole surgery for chronic subdural hematoma evacuation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

dexmedetomidine- ketamine

Drug

patients will receive combination of ketamine 1mg/kg and dexmedetomidine 1ug/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 names: precedex- katalar

dexmedetomidine- propofol

Drug

patients will receive combination from 0.5 mg/kg propofol and dexmedetomidine 1ug/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 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 names: precedex- diprivan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. rescue analgesic (fentanyl)

    Time frame: intraoperative

    Total number of calling intraoperative rescue analgesic (fentanyl) in both groups will be recorded.

  3. 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%

  4. Recovery time

    Time frame: with in one hour postoperative

    Recovery time: time from discontinuation of infusion drugs till spontaneous eye opening.

  5. 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.

  6. surgeon satisfaction

    Time frame: with in 24 hours after surgery

    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.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol Combination During Burr-Hole Surgery For Chronic Subdural Hematoma

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2020
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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