Comparative Effect of Hypotensive Anaesthesia on Event Related Potentials, Quantitative Electroencephalograghy

NCT04110808 | Unknown Early Phase 1

• 1 other identifier: hypotensive anaesthesia
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

AIM OF THE WORK The aim of this work was to compare the effect of hypotensive anaesthesia using Nitroglycerine versus phentolamine on Event related potentials, quantitative Electroencephalograghy and cognitive function, in patients undergoing septoplasty.

Conditions

Effect of Drugs

Outcome Measures

Primary Outcomes (2)

• Paired Associate Learning test for assessment of Cognitive function

  Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine

  1 week

• Benton Visual Retention test for assessment of Cognitive function

  Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine

  1 week

Secondary Outcomes (2)

• Quantitative Electroencephalograghy for assessment of electrical activity of the brain

  1 week

• Event related potentials (ERP ) P300 for neurophysiological assessment of cognition

  1 week

Study Arms (2)

Nitroglycerine

ACTIVE COMPARATOR

Patients will receive hypotensive anesthesia with nitroglycerine infusion via syringe pump by adding 5mg (5ml) of Nitroglycerin to 45ml of normal saline making it to final concentration of 100μg/ml at the rate of 0.5- 10 μg/kg/min according to the patients desired target blood pressure.

Drug: hypotensive anaesthesia using Nitroglycerine

Phentolamine

OTHER

Patients will receive hypotensive anesthesia with phentolamine infusion via syringe pump by adding 20 mg (2ml) of Phentolamine to 48 ml of normal saline making it to final concentration of 0.4 mg/ml at the rate of 0.1-2 mg/min according to the patients desired target blood pressure.

Drug: hypotensive anaesthesia using Nitroglycerine

Interventions

hypotensive anaesthesia using Nitroglycerine DRUG

effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine on Event related potentials, quantitative Electroencephalograghy and cognitive function Phentolamine group (30 patients): Patients will receive hypotensive anesthesia with phentolamine infusion via syringe pump by adding 20 mg (2ml) of Phentolamine to 48 ml of normal saline making it to final concentration of 0.4 mg/ml at the rate of 0.1-2 mg/min according to the patients desired target blood pressure. Nitroglycerine group (30 patients): Patients will receive hypotensive anesthesia with nitroglycerine infusion via syringe pump by adding 5mg (5ml) of Nitroglycerin to 45ml of normal saline making it to final concentration of 100μg/ml at the rate of 0.5- 10 μg/kg/min according to the patients desired target blood pressure.

Also known as: hypotensive anaesthesia using Phentolamine

Nitroglycerine; Phentolamine

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients who are candidate for septoplasty
• Patients from both sexes, aged between 20-50 years

You may not qualify if:

• Patients who develop intraoperative shock or major bleeding
• Patients with ischemic heart diseases, heart block, congestive heart failure, valvular heart diseases, or uncontrolled hypertension
• Patients with a history of central neurological system disorder
• Patients with concomitant medical or metabolic illness known to affect cognition
• Pregnant females
• Allergy to any of the anaesthetic or hypotensive drugs used in the study

Sponsors & Collaborators

• Beni-Suef University: lead

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology lecturer

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: October 1, 2019
• Study Start: October 15, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: October 1, 2019

Record last verified: 2019-09