Nasal PolypsPhase 1NCT05828199
The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine
A Phase 1 study testing Ketamine Hydrochloride and Dexmedetomidine in people with Nasal Polyps and Nasal Septum, Irregular, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Comparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose… Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Nasal Polyps, Nasal Septum, Irregular, Functional Endoscopic Sinus Surgery
- What is being tested?
- Ketamine Hydrochloride and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 20 Dec 2023
- Phase
- 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 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Between 21 and 40 years of age, they with American Society of Anesthesiologists (ASA) physical status I-II and undergoing nasal and paranasal sinus surgery.
Who cannot join
- • Refusal to join the study.
- Allergy to the drugs used in the study.
- Drug and/or alcohol abuse.
- Mental and psychiatric disorders.
- Emergency operations.
- Patients with systemic illnesses (eg, hypertension [ SBP >160 mm Hg], diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Al-Azhar University
Cairo
Essam Ali, Professor, 01223215181, essamalhalawany@gmail.com
Ibrahim Metwaly Bauomy, Professor
About this study
Official title: Comparative Evaluation The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine on Pain and Inflammatory Biomarkers in Patients Undergoing Nasal Surgery
Comparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose and CRP.
Read the detailed description
The primary objective of anesthesia is balancing the patient's hemodynamics with the best possible surgical outcome. In modern anesthesia, a multimodal approach to balanced anesthesia is targeted with combined general anesthetics and systemic drugs.
Trans-nasal endoscopic surgery (TNES) is a helpful diagnostic and therapeutic modality in paranasal sinus diseases. TNES are associated with significant intraoperative bleeding, pain, epistaxis, and transient headaches .
Intra-operative surgical site bleeding is one major complication and all anesthetic techniques pursue the objective to reduce it to achieve better precision, reduced operative time, and faster postoperative wound healing.
Topical medications, surgical positioning, nasal packing, inhalational anesthetics, and systemic drugs are some of the documented methods.
Controlled hypotension is one of the methods to control bleeding. It reduces blood loss, enhances the operative field quality (dryness) and studies on hypotensive anesthesia have shown a statistically significant reduction in blood loss .
Several systemic drugs have been used to achieve controlled hypotension. However, they have their own set of limitations .
Dexmedetomidine, a highly selective α2 adrenoreceptor agonist, has anxiolytic, sedative, anesthetic, and analgesic properties. It has limited side effects in terms of respiratory depression. Because of these favorable properties, it is commonly used in a wide variety of procedures .
Dexmedetomidine is a relatively new drug approved at the end of 1999 by the Food and Drug Administration (FDA) for humans use for short-term sedationand analgesia (<24 hours) in the intensive care unit (ICU). Dexmedetomidine is a useful sedative agent with analgesic properties, hemodynamic stability and ability to recover respiratory function in mechanically ventilated patients facilitating early weaning .
Ketamine hydrochloride, a well-known anesthetic agent, has been in clinical use for more than four decades . Its antinociceptive-hypnotic effects are most likely the result of the noncompetitive antagonism at the N-methyl-D-aspartate (NMDA) receptor of the central nervous system .
Ketamine is used as an analgesic in low doses and as an anesthetic in high doses. It is suggested that ketamine maintains analgesia and reduces postoperative opioid use, whether used alone or in combination with other anesthetic agents, The perioperative use of ketamine in surgery with moderate-to-severe postoperative pain is recommended by the American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine, and American Society of Anesthesiologists.
Cytokines regulate the host response to infection, the immune response, inflammation, and trauma. Surgical stress has been reported to be associated with elevated cytokines response. IL-6 is highly expressed during inflammatory responses to conditions of stress, and can be used to assess the severity of surgical trauma.
The stress response to surgery is characterized by increased secretion of pituitary hormones and activation of the sympathetic nervous system, For example, release of corticotrophin from the pituitary stimulates cortisol secretion from the adrenal cortex .
- Being tested
- Ketamine Hydrochloride, Dexmedetomidine
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Comparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose and CRP.
DexmedetomidineDrug
bolus dose of dexmedetomidine 0.5-1 μg/kg in 100 mL of normal saline over 10 minutes then, continuous infusion dose of dexmedetomidine 0.2 ug/kg/hr
| Study group | Role | What they receive |
|---|---|---|
| Dexmedtomidine group | Active comparator | About 40 patients will receive bolus dose of dexmedetomidine 0.5-1 μg/kg in 100 mL of normal saline over 10 minutes then, continuous infusion dose of dexmedetomidine 0.2 ug/kg/hr. Receives: Drug: Dexmedetomidine |
| ketamin group | Active comparator | About 40 patients will receive a ketamine bolus dose (0.3 mg/kg IV slowly), then continuous infusion dose of ketamine (0.2 mg/kg/hr). Receives: Drug: Ketamine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postoperative pain
Assessed by VAS score.As (VAS:0-10, where 0 = no pain, and 10 = worst possible pain). Before surgery, all patients will be a short education about VAS.
Measured: from 0 hours to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hegazy, Al-Azhar University
- Investigators
- Essam Ali, Professor, Study chair, Al-Azhar University, Faculty of medicine for boys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828199
- Sponsor's protocol ID
- Ahmed Hegazy
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation The Effect of Intraoperative Infusion of Dexmedetomidine Versus Low Dose Ketamine on Pain and Inflammatory Biomarkers in Patients Undergoing Nasal Surgery
- ClinicalTrials.gov ID
- NCT05828199
- Acronym / sponsor ID
- Ahmed Hegazy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 25 Apr 2023 (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.
Comparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose and CRP.
Detailed description
The primary objective of anesthesia is balancing the patient's hemodynamics with the best possible surgical outcome. In modern anesthesia, a multimodal approach to balanced anesthesia is targeted with combined general anesthetics and systemic drugs.
Trans-nasal endoscopic surgery (TNES) is a helpful diagnostic and therapeutic modality in paranasal sinus diseases. TNES are associated with significant intraoperative bleeding, pain, epistaxis, and transient headaches .
Intra-operative surgical site bleeding is one major complication and all anesthetic techniques pursue the objective to reduce it to achieve better precision, reduced operative time, and faster postoperative wound healing.
Topical medications, surgical positioning, nasal packing, inhalational anesthetics, and systemic drugs are some of the documented methods.
Controlled hypotension is one of the methods to control bleeding. It reduces blood loss, enhances the operative field quality (dryness) and studies on hypotensive anesthesia have shown a statistically significant reduction in blood loss .
Several systemic drugs have been used to achieve controlled hypotension. However, they have their own set of limitations .
Dexmedetomidine, a highly selective α2 adrenoreceptor agonist, has anxiolytic, sedative, anesthetic, and analgesic properties. It has limited side effects in terms of respiratory depression. Because of these favorable properties, it is commonly used in a wide variety of procedures .
Dexmedetomidine is a relatively new drug approved at the end of 1999 by the Food and Drug Administration (FDA) for humans use for short-term sedationand analgesia (<24 hours) in the intensive care unit (ICU). Dexmedetomidine is a useful sedative agent with analgesic properties, hemodynamic stability and ability to recover respiratory function in mechanically ventilated patients facilitating early weaning .
Ketamine hydrochloride, a well-known anesthetic agent, has been in clinical use for more than four decades . Its antinociceptive-hypnotic effects are most likely the result of the noncompetitive antagonism at the N-methyl-D-aspartate (NMDA) receptor of the central nervous system .
Ketamine is used as an analgesic in low doses and as an anesthetic in high doses. It is suggested that ketamine maintains analgesia and reduces postoperative opioid use, whether used alone or in combination with other anesthetic agents, The perioperative use of ketamine in surgery with moderate-to-severe postoperative pain is recommended by the American Society of Regional Anesthesia and Pain Medicine, American Academy of Pain Medicine, and American Society of Anesthesiologists.
Cytokines regulate the host response to infection, the immune response, inflammation, and trauma. Surgical stress has been reported to be associated with elevated cytokines response. IL-6 is highly expressed during inflammatory responses to conditions of stress, and can be used to assess the severity of surgical trauma.
The stress response to surgery is characterized by increased secretion of pituitary hormones and activation of the sympathetic nervous system, For example, release of corticotrophin from the pituitary stimulates cortisol secretion from the adrenal cortex .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedtomidine group | Active comparator | Drug: DexmedetomidineAbout 40 patients will receive bolus dose of dexmedetomidine 0.5-1 μg/kg in 100 mL of normal saline over 10 minutes then, continuous infusion dose of dexmedetomidine 0.2 ug/kg/hr. |
| ketamin group | Active comparator | Drug: Ketamine HydrochlorideAbout 40 patients will receive a ketamine bolus dose (0.3 mg/kg IV slowly), then continuous infusion dose of ketamine (0.2 mg/kg/hr). |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- • Between 21 and 40 years of age, they with American Society of Anesthesiologists (ASA) physical status I-II and undergoing nasal and paranasal sinus surgery.
Key exclusion criteria (6 listed)
- • Refusal to join the study.
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 |
|---|---|---|
| Ketamine HydrochlorideComparing between dexmedetomidine versus low dose ketamine infusion in patients undergoing nasal and paranasal sinus surgery as regard, intraoperative hemodynamic stability, blood loss, perioperative opioid requirements, Stress response evaluation through the measurement of serum level of cortisol, IL-6, blood glucose and CRP. | Drug | ketamin group |
| Dexmedetomidinebolus dose of dexmedetomidine 0.5-1 μg/kg in 100 mL of normal saline over 10 minutes then, continuous infusion dose of dexmedetomidine 0.2 ug/kg/hr | Drug | Dexmedtomidine group |
Primary outcome
The postoperative pain
Time frame: from 0 hours to 24 hours after the procedure
Assessed by VAS score.As (VAS:0-10, where 0 = no pain, and 10 = worst possible pain). Before surgery, all patients will be a short education about VAS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Essam Ali, Professor study chair
Al-Azhar University, Faculty of medicine for boys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine Hydrochloride and Dexmedetomidine in people with Nasal Polyps and Nasal Septum, Irregular, run by Al-Azhar University at 1 site in Egypt.
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 1 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Ahmed Gamal, assist.lect (01099549595, ahmedgamal.226@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The postoperative pain (time frame: from 0 hours to 24 hours after the procedure). 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 25 Apr 2023.