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

Conscious Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04621526
• Other study ID #: 6434
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 10, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

- 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Conscious Sedation
• Hematoma
• Hematoma, Subdural, Chronic

Intervention

Drug:
• dexmedetomidine- ketamine
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.
• dexmedetomidine- propofol
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.

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitsals	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The onset time of sedation	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).	with in 30 minutes before start of surgery
Secondary	The extent of airway obstruction	The extent of airway obstruction by (1= patent airway, 2= airway obstruction alleviated by jaw thrust, 3= airway obstruction alleviated by positive mask ventilation)	intraopertive
Secondary	rescue analgesic (fentanyl)	Total number of calling intraoperative rescue analgesic (fentanyl) in both groups will be recorded.	intraoperative
Secondary	number of participant with complications	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%	intraoperative
Secondary	Recovery time	Recovery time: time from discontinuation of infusion drugs till spontaneous eye opening.	with in one hour postoperative
Secondary	The Neurological status of participants	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.	at baseline then within one hour postoperative
Secondary	surgeon satisfaction	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.	with in 24 hours after surgery