Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy

Effect of Dexmedetomidine Versus Propofol on the Onset and Recovery of Sedation in Stereotactic Brain Biopsy A Comparative Study

Pre-operative anxiety leads to higher sympathetic stimulation. Propofol in the main drug used during interventional or imaging techniques that need sedation. Also, dexmedetomidine causes sedation, analgesia, sympatholytic properties, without respiratory depression.In stereotactic brain biopsy; patient discomfort due to drilling a hole through the skull and the advancement of the biopsy needle make the patient in need for good sedation and analgesia.

Study Overview

• Status: Completed
• Conditions: Adverse Effects in the Therapeutic Use of Other and Unspecified Agents Primarily Acting on the Respiratory System
• Intervention / Treatment: Drug: dexmedetomidine/ propofol

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

Patients with:

• brain secondaries from the lung/breast/pancreas
• tuberculoma
• pyogenic abscess
• intra-axial supratentorial space occupying lesion with or without hydrocephalus *an average duration of the procedure 1- 2hr 30 min
• an available caregiver for overnight observation
• patient relative proximity to the hospital Exclusion criteria

Patients with:

• morbid obesity (body mass index >35 kg/m2)
• significant comorbidities (a known history of hepatic disease, renal dysfunction, hypertension, and chronic pain)
• history of drug or alcohol abuse
• an allergic reaction to one of the study medications
• anticipated difficult airway
• uncontrolled epilepsy
• poor neurological status
• neuropsychological unsuitability taking psychotropic drugs (benzodiazepines and barbiturates)
• patients with brain stem lesions (vital areas of brain)
• un-cooperative
• refusing adults
• patients with ventricular drain
• already inpatient
• Intubated patients and those who had a prior craniotomy .

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hemodynamic parameters	Drug: dexmedetomidine/ propofol; The loading and infusion doses of dexmedetomidine hydrochloride and 1% propofol were calculated according to the patient's body weight and diluted to a 10 ml volume (labeled as loading-1 and loading-2) and a 50 ml volume (labeled as infusion-1 and infusion-2).
Other: Ramsay sedation score	Drug: dexmedetomidine/ propofol; The loading and infusion doses of dexmedetomidine hydrochloride and 1% propofol were calculated according to the patient's body weight and diluted to a 10 ml volume (labeled as loading-1 and loading-2) and a 50 ml volume (labeled as infusion-1 and infusion-2).
Other: Intraoperative side effects	Drug: dexmedetomidine/ propofol; The loading and infusion doses of dexmedetomidine hydrochloride and 1% propofol were calculated according to the patient's body weight and diluted to a 10 ml volume (labeled as loading-1 and loading-2) and a 50 ml volume (labeled as infusion-1 and infusion-2).
Other: recovery of sedation	Drug: dexmedetomidine/ propofol; The loading and infusion doses of dexmedetomidine hydrochloride and 1% propofol were calculated according to the patient's body weight and diluted to a 10 ml volume (labeled as loading-1 and loading-2) and a 50 ml volume (labeled as infusion-1 and infusion-2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the sedation characteristics	Ramsay sedation score	4 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 4, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 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, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: FMASU R44/ 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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