AnesthesiaPhase 4NCT05626998
Dexmedetomidine Versus Gabapentin Premedication on the Emergence Agitation After Rhinoplasty
A Phase 4 study testing Dexmedetomidine and Gabapentin in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dexmedetomidine and Gabapentin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Apr 2023
- Phase
- Phase 4
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- American Society of Anesthesiologists grade I or II.
- Sex: Both sexes.
- Age between 18 and 40 years.
- Patients scheduled for rhinoplasty under general anesthesia
Who cannot join
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- history of cardiovascular diseases including bradycardia, heart block, and hypertension.
- History of chest problems including bronchial asthma.
- Had a history of drug or alcohol abuse.
- Taking opioids or sedative medications.
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- Inability to communicate with patients to evaluate postoperative pain.
- Hepatic or renal failure.
- Psychiatric disorders with antipsychotics or antidepressants.
- Bleeding disorders, antiplatelets (aspirin, clopidogrel), or anticoagulant (warfarin).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intramuscular Dexmedetomidine Versus Oral Gabapentin Premedication on the Emergence Agitation After Rhinoplasty. A Prospective, Randomized, Double-blind Controlled Trial.
To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.
Read the detailed description
Emergence agitation (EA) is a clinical condition characterized by agitation, confusion, disorientation, and aggressive behavior in the early phase of recovery from general anesthesia (incidence about 21.3%). This may lead to various injuries, self-extubation, bleeding, increased pain, removal of catheters, increased blood pressure, heart rate, and myocardial oxygen consumption. Premedication with dexmedetomidine and gabapentin are promising options for EA.
- Conditions
- Anesthesia
- Being tested
- Dexmedetomidine, Gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward.
GabapentinDrug
The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The participants will not receive premedication |
| Dexmedetomidine | Active comparator | The participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward Receives: Drug: Dexmedetomidine |
| Gabapentin | Active comparator | The participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
emergence agitation (EA)
in the form of Riker Sedation-Agitation Scale (where 1 = "unarousable" and 7 = "dangerous agitation" with score ≥5 considered EA).
Measured: During first hour of recovery.
Secondary outcomes (2)
Postoperative pain in the form of visual analog scale
(VAS, 0=no pain; 10=worst possible pain)
Measured: every 4 hours for 12 hours
Incidence of the common adverse effects
nausea and vomiting, dizziness, and headache
Measured: at 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start1 Nov 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
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 AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Samir Abdelsalam, Ain Shams University
- Investigators
- tamer S abdelaziz, MD, Principal investigator, Faculty of medicine, Ain Shams University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626998
- Sponsor's protocol ID
- FMASU R 164/ 2022
- Status last verified
- Aug 2023
- First submitted
- 8 Nov 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdelaziz TSA, Mohammed Elsayed HE, Kamal Eldin DM, Ibrahim IM. "The effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty". A prospective, randomized, double-blind controlled trial. BMC Anesthesiol. 2025 Jan 31;25(1):50. doi: 10.1186/s12871-025-02914-5.
PubMed 39891093
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intramuscular Dexmedetomidine Versus Oral Gabapentin Premedication on the Emergence Agitation After Rhinoplasty. A Prospective, Randomized, Double-blind Controlled Trial.
- ClinicalTrials.gov ID
- NCT05626998
- Acronym / sponsor ID
- FMASU R 164/ 2022
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 25 Nov 2022 (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.
To compare the effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty.
Detailed description
Emergence agitation (EA) is a clinical condition characterized by agitation, confusion, disorientation, and aggressive behavior in the early phase of recovery from general anesthesia (incidence about 21.3%). This may lead to various injuries, self-extubation, bleeding, increased pain, removal of catheters, increased blood pressure, heart rate, and myocardial oxygen consumption. Premedication with dexmedetomidine and gabapentin are promising options for EA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The participants will not receive premedication |
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineThe participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward |
| Gabapentin | Active comparator | Drug: GabapentinThe participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists grade I or II.
- Sex: Both sexes.
- Age between 18 and 40 years.
- Patients scheduled for rhinoplasty under general anesthesia
Key exclusion criteria (10 listed)
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- history of cardiovascular diseases including bradycardia, heart block, and hypertension.
- History of chest problems including bronchial asthma.
- Had a history of drug or alcohol abuse.
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 |
|---|---|---|
| DexmedetomidineThe participants will receive intramuscular dexmedetomidine injection (1 µg/kg) diluted in 2ml normal saline thirty minutes before surgery in the ward. | Drug | Dexmedetomidine |
| GabapentinThe participants will receive 600 mg gabapentin (two capsules each containing 300 mg) thirty minutes before surgery in the ward | Drug | Gabapentin |
Primary outcome
emergence agitation (EA)
Time frame: During first hour of recovery.
in the form of Riker Sedation-Agitation Scale (where 1 = "unarousable" and 7 = "dangerous agitation" with score ≥5 considered EA).
2 secondary outcomes
Postoperative pain in the form of visual analog scale
Time frame: every 4 hours for 12 hours
Incidence of the common adverse effects
Time frame: at 12 hours
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 30 Aug 2023.
- Derived from this study: PubMed 39891093Abdelaziz TSA, Mohammed Elsayed HE, Kamal Eldin DM, Ibrahim IM. "The effect of intramuscular dexmedetomidine versus oral gabapentin premedication on the emergence agitation after rhinoplasty". A prospective, randomized, double-blind controlled trial. BMC Anesthesiol. 2025 Jan 31;25(1):50. doi: 10.1186/s12871-025-02914-5.
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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.
tamer S abdelaziz, MD principal investigator
Faculty of medicine, Ain Shams University, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine and Gabapentin in people with Anesthesia, run by Ain Shams 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 4 inclusion and 10 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 30 Aug 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
emergence agitation (EA) (time frame: During first hour of recovery.). 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 NCT05626998, 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 30 Aug 2023.