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

NCT ID: NCT04621526

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-10
• Study Completion Date: 2023-08-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

dexmedetomidine- ketamine

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

dexmedetomidine- propofol

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

precedex- katalar; precedex- diprivan

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Alshaimaa Abdel Fattah Kamel

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alshaimaa Kamel, M.D

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

Locations

Zagazig University Hospitsals

Zagazig, , Egypt

Countries

Egypt

Other Identifiers

6434

Identifier Type: -

Identifier Source: org_study_id