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

NCT04621526 | Completed Phase 1

• 1 other identifier: 6434
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Conscious Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The extent of airway obstruction

  intraopertive

• rescue analgesic (fentanyl)

  intraoperative

• number of participant with complications

  intraoperative

• Recovery time

  with in one hour postoperative

• The Neurological status of participants

  at baseline then within one hour postoperative

Study Arms (2)

dexmedetomidine- ketamine

ACTIVE COMPARATOR

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

dexmedetomidine- propofol

ACTIVE COMPARATOR

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

Interventions

dexmedetomidine- ketamine 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.

Also known as: precedex- katalar

dexmedetomidine- ketamine

dexmedetomidine- propofol 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.

Also known as: precedex- diprivan

dexmedetomidine- propofol

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitsals

Zagazig, 055, Egypt

Location

Study Officials

• Alshaimaa Kamel, M.D

  Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 9, 2020
• Study Start: November 10, 2020
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

EG (1)