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

September 28, 2019 updated by: Mona Hussein, Beni-Suef University

Comparative Effect of Hypotensive Anaesthesia Using Nitroglycerine vs Phentolamine on Event Related Potentials, Quantitative Electroencephalograghy and Cognitive Function in Patients Undergoing Septoplasty

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

METHODS:

Study design and population: This is a pilot prospective randomized clinical trial that will be carried out on 60 patients candidate for septoplasty subjected to general hypotensive anaesthesia. The patients will be recruited from Ear, nose and throat surgery department, Beni-Suef University Hospital. All the participants will be required to offer a written informed consent

Sampling Technique:

Patients will be randomly assigned into one of two equal groups; the first group will receive nitroglycerine (30 participants) (nitroglycerine group) and the second group will receive phentolamine (30 participants) (phentolamine group). Randomization will be carried out using a closed opaque envelope technique with the anesthetist will pick up a sealed envelope which contains a paper with the name of the group to which the patient will be randomized is written. Whichever the group written on the paper, the patient will be scheduled to it.

All included patients will be subjected to the following:

1) Cognitive assessment:

Cognitive functions for the patients will be assessed (preoperative and 1 week postoperative) using the following psychometric tests:

  1. Paired Associate Learning test (PALT) Aim: to assess auditory verbal memory. The test uses the concept of semantic cueing

    .

  2. Benton Visual Retention test (BVRT) Aim: to assess visual perceptual, visual memory, visual motor and visuoconstructive abilities.

2) Neurophysiological assessment: Digital Electroencephalograghy (EEG), quantitative Electroencephalograghy (QEEG) and Event related potentials (ERPs) and will be done for all included patients (preoperative and 1 week postoperative).

Statistical analysis The sample size will be calculated using G*Power version 3.1.9.2 Software based on this pilot study. The probability of type I error (α) will be 5%, and the statistical power (1-β) should exceed 80%. The data will be coded and entered using: the statistical package for social science version 15 (SPSS v 15). Descriptive statistics will be reported as mean ± SD and number (%) for categorical variables. Student t- test will be used for comparison between means of two unpaired groups of quantitative variables. Paired sample t- test will be used for comparison between means of two paired groups of quantitative variables. Chi square test will be used for comparison between two groups of categorical data. Mixed ANOVA test will be used for comparing paired data in two unpaired groups. The probability/significance value (P value) ≥ 0.05 is not statistically significant and <0.05 is statistically significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Nitroglycerine
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

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.

Other Names:
  • hypotensive anaesthesia using Phentolamine
Other: Phentolamine
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

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.

Other Names:
  • hypotensive anaesthesia using Phentolamine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Paired Associate Learning test for assessment of Cognitive function
Time Frame: 1 week
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
1 week
Benton Visual Retention test for assessment of Cognitive function
Time Frame: 1 week
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quantitative Electroencephalograghy for assessment of electrical activity of the brain
Time Frame: 1 week
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
1 week
Event related potentials (ERP ) P300 for neurophysiological assessment of cognition
Time Frame: 1 week
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • hypotensive anaesthesia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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