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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Ahmed Gamal, assist.lect contact

01099549595

ahmedgamal.226@azhar.edu.eg

Mohamed AboElSuod, Assist.prof contact

01091945931

mohamed.abdelgawad@azhar.edu.eg

Egypt1 site, 1 recruiting
  • Faculty of Medicine, Al-Azhar University

    Cairo

    Essam Ali, Professor, 01223215181, essamalhalawany@gmail.com

    Ibrahim Metwaly Bauomy, Professor

    Recruiting

Other trials in Egypt

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 groups in NCT05828199
Study groupRoleWhat they receive
Dexmedtomidine groupActive comparatorAbout 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 groupActive comparatorAbout 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.

  1. 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.

  1. First posted25 Apr 2023
  2. Study start1 Dec 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion20 Dec 2023 (estimated)

Resources

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)
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

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.

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