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

Zagazig University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Conscious Sedation

Treatments: Drug: dexmedetomidine- propofol; Drug: dexmedetomidine- ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04621526

6434

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

dexmedetomidine- ketamine

Active Comparator group

Description:

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.

Treatment:

Drug: dexmedetomidine- ketamine

dexmedetomidine- propofol

Active Comparator group

Description:

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.

Treatment:

Drug: dexmedetomidine- propofol