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

Monitored Anesthesia Care: Dexmedetomidine-Ketamine Versus Dexmedetomidine- Propofol Combination During Burr-Hole Surgery 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.

Study Overview

• Status: Completed
• Conditions: Conscious Sedation
• Intervention / Treatment: Drug: dexmedetomidine- ketamine; Drug: dexmedetomidine- propofol

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Salwa ElSherbeny, M.D; Phone Number: 002 01128595629
• Study Contact Backup: Name: Alshaimaa Kamel, M.D; Phone Number: 002 01005593169; Email: AlshaimaaKamel80@yahoo.com

Study Locations

• Egypt
  • Zagazig, Egypt, 055
    • Zagazig University Hospitsals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.; Other Names: precedex- katalar
Active Comparator: dexmedetomidine- propofol; patients will receive combination from 1 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 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.	Drug: 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.; Other Names: precedex- diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
rescue analgesic (fentanyl)	Total number of calling intraoperative rescue analgesic (fentanyl) in both groups will be recorded.	intraoperative
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
Recovery time	Recovery time: time from discontinuation of infusion drugs till spontaneous eye opening.	with in one hour postoperative
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
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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Alshaimaa Kamel, M.D, Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Chronic Disease; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Propofol; Dexmedetomidine
• Other Study ID Numbers: 6434

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No