SedationPhase 2/3OTM/DEX/PKNCT03120247
Pharmacokinetics and Pharmacodynamics of Oral Transmucosal Dexmedetomidine.
A Phase 2/3 study testing OTM Dexmedetomidine 1µg/ kg., OTM Dexmedetomidine 0.75µg/ kg. and OTM Dexmedetomidine 0.5µg/ kg. in people with Sedation, run by Assiut University at 1 site in Egypt.
Trial summary
Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Sedation
- What is being tested?
- OTM Dexmedetomidine 1µg/ kg., OTM Dexmedetomidine 0.75µg/ kg. and OTM Dexmedetomidine 0.5µg/ kg.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2017to 1 Jul 2019
- Phase
- Phase 2/3
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I - II.
- Aged between 20 and 60 years.
- Scheduled for modified radical mastectomy
Who cannot join
- Cardiac disease.
- Hepatic disease.
- Renal disease.
- History of alcohol or drug abuse.
- Patients with a known allergy to the study drug
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Egypt cancer institute, Assiut university
Asyut, Assiut Governorate, 715715
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Three Doses of Oral Trans-mucosal Dexmedetomidine for Premedication in Patients Undergoing Modified Radical Mastectomy
Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.
Read the detailed description
The alpha2-adrenoceptor agonist, dexmedetomidine, was originally developed as a sedative and analgesic drug for use in intensive care. However, it has a number of unique pharmacodynamic properties, which also make it useful in anesthesia including; decreased MAC, analgesia without respiratory depression and a significant reduction in catecholamine secretion. Also it has been used off-label as an adjunctive agent for sedation and analgesia in patients in the critical care unit and for sedation during non-invasive procedures in radiology. It also has a potential role as part of anesthesia care to prevent emergence delirium and post-anesthesia shivering.
Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.
The current literature is focused in studying the sedative and analgesic effects of intravenously administered dexmedetomidine. Pharmacodynamics and pharmacokinetic studies undertaken on alternative routes of dexmedetomidine administration are lacking. The pharmacokinetic properties of trans-mucosal administration of dexmedetomidine have been demonstrated in one study only, and the clinical effects of non-parenteral administration of dexmedetomidine have been described in anecdotal case reports.
- Conditions
- Sedation
- Being tested
- OTM Dexmedetomidine 1µg/ kg., OTM Dexmedetomidine 0.75µg/ kg., OTM Dexmedetomidine 0.5µg/ kg.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTM Dexmedetomidine 1µg/ kg.Drug
Also called Precedex
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
OTM Dexmedetomidine 0.75µg/ kg.Drug
Also called Precedx
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
OTM Dexmedetomidine 0.5µg/ kg.Drug
Also called Precedex
Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
| Study group | Role | What they receive |
|---|---|---|
| DEX I | Active comparator | OTM Dexmetetomidine 1µg/kg Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. Receives: Drug: OTM Dexmedetomidine 1µg/ kg. |
| DEX II | Active comparator | OTM Dexmetetomidine0.75µg/kg Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. Receives: Drug: OTM Dexmedetomidine 0.75µg/ kg. |
| DEX III | Active comparator | OTM Dexmetetomidine 0.5µg/kg. Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. Receives: Drug: OTM Dexmedetomidine 0.5µg/ kg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax)
Measured: 360 minutes.
Secondary outcomes (4)
Sedation preoperative
Sedation score is recorded pre-operatively every 5minutes for 30 minutes after OTM DEX administration
Measured: 30 minutes
Blood pressure preoperative
Non invasive blood pressure will be recorded every 5 minutes for 30 minutes after OTM DEX administration.
Measured: 30 minutes.
Heart rate preoperative
Heart rate will be recorded every 5 minutes for 30 minutes after OTM DEX administration.
Measured: 30 minutes
Area under the plasma concentration versus time curve (AUC)
Two milliliters of blood will be collected for determination of Area under the plasma concentration versus time
Measured: 360 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start5 Apr 2017
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pharmacokinetic and pharmacodynamic study of three different doses of oral transmucosal dexmedetomidine
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Saher A Mohamed, MD, Principal investigator, Assistant professor in anesthesia and pain management, South Egypt Cancer Institute, faculty of medicine, Assiut university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120247
- Sponsor's protocol ID
- IORG0006563/no. 377
- Acronym
- OTM/DEX/PK
- Status last verified
- Jul 2019
- First submitted
- 5 Apr 2017
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mohamed SA, Abdel-Ghaffar HS, Hassan NA, El Sherif FA, Shouman SA, Omran MM, Hassan SB, Allam AAAE, Sayed DG. Pharmacokinetics and Pharmacodynamics of 3 Doses of Oral-Mucosal Dexmedetomidine Gel for Sedative Premedication in Women Undergoing Modified Radical Mastectomy for Breast Cancer. Anesth Analg. 2021 Feb 1;132(2):456-464. doi: 10.1213/ANE.0000000000005108.
PubMed 32889844
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Three Doses of Oral Trans-mucosal Dexmedetomidine for Premedication in Patients Undergoing Modified Radical Mastectomy
- ClinicalTrials.gov ID
- NCT03120247
- Acronym / sponsor ID
- OTM/DEX/PK / IORG0006563/no. 377
- Conditions
- Sedation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 19 Apr 2017 (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.
Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.
Detailed description
The alpha2-adrenoceptor agonist, dexmedetomidine, was originally developed as a sedative and analgesic drug for use in intensive care. However, it has a number of unique pharmacodynamic properties, which also make it useful in anesthesia including; decreased MAC, analgesia without respiratory depression and a significant reduction in catecholamine secretion. Also it has been used off-label as an adjunctive agent for sedation and analgesia in patients in the critical care unit and for sedation during non-invasive procedures in radiology. It also has a potential role as part of anesthesia care to prevent emergence delirium and post-anesthesia shivering.
Oral trans-mucosal administration is relatively easy and convenient, it also reduces first pass metabolism and has been used successfully for fentanyl, ketamine, and midazolam premedication.
The current literature is focused in studying the sedative and analgesic effects of intravenously administered dexmedetomidine. Pharmacodynamics and pharmacokinetic studies undertaken on alternative routes of dexmedetomidine administration are lacking. The pharmacokinetic properties of trans-mucosal administration of dexmedetomidine have been demonstrated in one study only, and the clinical effects of non-parenteral administration of dexmedetomidine have been described in anecdotal case reports.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Pharmacokinetic and pharmacodynamic study of three different doses of oral transmucosal dexmedetomidine
| Arm | Type | Receives |
|---|---|---|
| DEX I | Active comparator | Drug: OTM Dexmedetomidine 1µg/ kg.OTM Dexmetetomidine 1µg/kg Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. |
| DEX II | Active comparator | Drug: OTM Dexmedetomidine 0.75µg/ kg.OTM Dexmetetomidine0.75µg/kg Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. |
| DEX III | Active comparator | Drug: OTM Dexmedetomidine 0.5µg/ kg.OTM Dexmetetomidine 0.5µg/kg. Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status I - II.
- Aged between 20 and 60 years.
- Scheduled for modified radical mastectomy
Key exclusion criteria (5 listed)
- Cardiac disease.
- Hepatic disease.
- Renal disease.
- History of alcohol or drug abuse.
- Patients with a known allergy to the study drug
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 |
|---|---|---|
| OTM Dexmedetomidine 1µg/ kg.Also: PrecedexOral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. | Drug | DEX I |
| OTM Dexmedetomidine 0.75µg/ kg.Also: PrecedxOral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. | Drug | DEX II |
| OTM Dexmedetomidine 0.5µg/ kg.Also: PrecedexOral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure. | Drug | DEX III |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 360 minutes.
Two milliliters of blood will be collected for determination of Peak Plasma Concentration (Cmax)
4 secondary outcomes
Sedation preoperative
Time frame: 30 minutes
Blood pressure preoperative
Time frame: 30 minutes.
Heart rate preoperative
Time frame: 30 minutes
Area under the plasma concentration versus time curve (AUC)
Time frame: 360 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Derived from this study: PubMed 32889844Mohamed SA, Abdel-Ghaffar HS, Hassan NA, El Sherif FA, Shouman SA, Omran MM, Hassan SB, Allam AAAE, Sayed DG. Pharmacokinetics and Pharmacodynamics of 3 Doses of Oral-Mucosal Dexmedetomidine Gel for Sedative Premedication in Women Undergoing Modified Radical Mastectomy for Breast Cancer. Anesth Analg. 2021 Feb 1;132(2):456-464. doi: 10.1213/ANE.0000000000005108.
- Individual participant dataSharing planned: No
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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.
Saher A Mohamed, MD principal investigator
Assistant professor in anesthesia and pain management, South Egypt Cancer Institute, faculty of medicine, Assiut university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing OTM Dexmedetomidine 1µg/ kg., OTM Dexmedetomidine 0.75µg/ kg. and OTM Dexmedetomidine 0.5µg/ kg. in people with Sedation, run by Assiut 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 1 Aug 2019. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak Plasma Concentration (Cmax) (time frame: 360 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03120247, which also lists 1 linked publication.
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 Aug 2019.