Effect of DrugsEarly Phase 1NCT04110808
Comparative Effect of Hypotensive Anaesthesia on Event Related Potentials, Quantitative Electroencephalograghy
A Early Phase 1 study testing hypotensive anaesthesia using Nitroglycerine in people with Effect of Drugs, run by Beni-Suef University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Drugs
- What is being tested?
- hypotensive anaesthesia using Nitroglycerine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2019to 1 Feb 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are candidate for septoplasty
- Patients from both sexes, aged between 20-50 years
Who cannot join
- 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
About this study
Official title: 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.
Read the 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:
- Cognitive assessment:
Cognitive functions for the patients will be assessed (preoperative and 1 week postoperative) using the following psychometric tests:
- Paired Associate Learning test (PALT) Aim: to assess auditory verbal memory. The test uses the concept of semantic cueing .
- Benton Visual Retention test (BVRT) Aim: to assess visual perceptual, visual memory, visual motor and visuoconstructive abilities.
- 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.
- Conditions
- Effect of Drugs
- Being tested
- hypotensive anaesthesia using Nitroglycerine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypotensive anaesthesia using NitroglycerineDrug
Also called hypotensive anaesthesia using Phentolamine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: hypotensive anaesthesia using Nitroglycerine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired Associate Learning test for assessment of Cognitive function
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
Measured: 1 week
Benton Visual Retention test for assessment of Cognitive function
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
Measured: 1 week
Secondary outcomes (2)
Quantitative Electroencephalograghy for assessment of electrical activity of the brain
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
Measured: 1 week
Event related potentials (ERP ) P300 for neurophysiological assessment of cognition
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start15 Oct 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Hussein, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110808
- Sponsor's protocol ID
- hypotensive anaesthesia
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Hypotensive Anaesthesia Using Nitroglycerine vs Phentolamine on Event Related Potentials, Quantitative Electroencephalograghy and Cognitive Function in Patients Undergoing Septoplasty
- ClinicalTrials.gov ID
- NCT04110808
- Acronym / sponsor ID
- hypotensive anaesthesia
- Conditions
- Effect of Drugs
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Cognitive assessment:
Cognitive functions for the patients will be assessed (preoperative and 1 week postoperative) using the following psychometric tests:
- Paired Associate Learning test (PALT) Aim: to assess auditory verbal memory. The test uses the concept of semantic cueing .
- Benton Visual Retention test (BVRT) Aim: to assess visual perceptual, visual memory, visual motor and visuoconstructive abilities.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitroglycerine | Active comparator | Drug: hypotensive anaesthesia using NitroglycerinePatients 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. |
| Phentolamine | Other | Drug: hypotensive anaesthesia using NitroglycerinePatients 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who are candidate for septoplasty
- Patients from both sexes, aged between 20-50 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypotensive anaesthesia using NitroglycerineAlso: hypotensive anaesthesia using Phentolamineeffect 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. | Drug | Nitroglycerine, Phentolamine |
Primary outcome
Paired Associate Learning test for assessment of Cognitive function
Time frame: 1 week
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
Benton Visual Retention test for assessment of Cognitive function
Time frame: 1 week
Comparative effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine
2 secondary outcomes
Quantitative Electroencephalograghy for assessment of electrical activity of the brain
Time frame: 1 week
Event related potentials (ERP ) P300 for neurophysiological assessment of cognition
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing hypotensive anaesthesia using Nitroglycerine in people with Effect of Drugs, run by Beni-Suef University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paired Associate Learning test for assessment of Cognitive function (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.