NCT04621526

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

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

* 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.

Conditions

• Conscious Sedation

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-11-10
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2020-11-09
• Last updated: 2023-10-17

Locations

1 site across 1 country: Egypt