Postoperative DeliriumPhase 3NCT05634148
Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery
A Phase 3 study testing Dexmedetomidine in people with Postoperative Delirium, run by Security Forces Hospital at 1 site in Saudi Arabia.
Trial summary
Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 22 Dec 2022to 1 Apr 2023
- Phase
- Phase 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- We will include patients aged 15 years to 65 years, ASA 1-3 who are planned to undergo general anesthesia for elective nasal surgeries in which nasal packing is used postoperatively
Who cannot join
- We will exclude patients with known allergy to study medications, BMI more than 35, history of obstructive sleep apnea, history of psychiatric illness, pregnancy and presence of liver and renal diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Single Dose Infusion of Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery - a Randomised Contolled Trial
Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.
Read the detailed description
Emergence agitation (EA) or delirium is a post anesthesia complication which is manifested as confusion, agitation, disorientation and aggressive behavior. It can lead to serious consequences including hemorrhage, removal of lines, drains and catheters, self-extubation and even falling out of bed resulting in severe injuries. EA is associated with cognitive deficit, physical dependence, increased hospital stay and higher mortality.
There is wide variation in the incidence of EA in scientific literature ranging from 5 % to 27.3 %. There are no clear diagnostic criteria for EA because of its varied clinical manifestations. Although many risk factors have been identified including pain, presence of stress at the time of induction, induction with etomidate, use of premedication with benzodiazepines, hypoxemia, type of surgery, awakening in hostile and noisy environment and presence of urinary catheter. Patients undergoing nasal surgeries are in particular, at higher risk for EA due to a sense of suffocation secondary to nasal packing.
Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.
- Conditions
- Postoperative Delirium
- Being tested
- Dexmedetomidine
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Control
Intravenous dexmedetomidine will be administered 45 minutes before extubation in intervention group
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Patients in this group will receive intravenous dexmedetomidine before extubation Receives: Drug: Dexmedetomidine |
| Control group | Placebo comparator | Patients in this group will receive intravenous placebo (0.9 % saline) before extubation Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Riker sedation-agitation score
Assessment of emergence delirium after extubation. It has numbers from 1-7.
Measured: 60 minutes
Secondary outcomes (4)
Postoperative pain score
Numerical rating scale pain score in PACU. from 0 to 10 with 10 worst pain
Measured: 60 minutes
Opioid consumption
Morphine equivalent consumption in PACU
Measured: 60 minutes
Adverse events
Intraoperative or postoperative adverse events
Measured: 60 minutes
Duration of stay in PACU
duration of PACU stay
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start22 Dec 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Security Forces Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anwar ul Huda, Security Forces Hospital
- Investigators
- Anwar Huda, FRCA, Principal investigator, Security Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634148
- Sponsor's protocol ID
- SFH-Dex Nasal
- Status last verified
- Apr 2023
- First submitted
- 21 Nov 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Dose Infusion of Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery - a Randomised Contolled Trial
- ClinicalTrials.gov ID
- NCT05634148
- Acronym / sponsor ID
- SFH-Dex Nasal
- Conditions
- Postoperative Delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Security Forces HospitalUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 2 Dec 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.
Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.
Detailed description
Emergence agitation (EA) or delirium is a post anesthesia complication which is manifested as confusion, agitation, disorientation and aggressive behavior. It can lead to serious consequences including hemorrhage, removal of lines, drains and catheters, self-extubation and even falling out of bed resulting in severe injuries. EA is associated with cognitive deficit, physical dependence, increased hospital stay and higher mortality.
There is wide variation in the incidence of EA in scientific literature ranging from 5 % to 27.3 %. There are no clear diagnostic criteria for EA because of its varied clinical manifestations. Although many risk factors have been identified including pain, presence of stress at the time of induction, induction with etomidate, use of premedication with benzodiazepines, hypoxemia, type of surgery, awakening in hostile and noisy environment and presence of urinary catheter. Patients undergoing nasal surgeries are in particular, at higher risk for EA due to a sense of suffocation secondary to nasal packing.
Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients in this group will receive intravenous dexmedetomidine before extubation |
| Control group | Placebo comparator | Drug: DexmedetomidinePatients in this group will receive intravenous placebo (0.9 % saline) before extubation |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- We will include patients aged 15 years to 65 years, ASA 1-3 who are planned to undergo general anesthesia for elective nasal surgeries in which nasal packing is used postoperatively
Key exclusion criteria (1 listed)
- We will exclude patients with known allergy to study medications, BMI more than 35, history of obstructive sleep apnea, history of psychiatric illness, pregnancy and presence of liver and renal diseases.
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 |
|---|---|---|
| DexmedetomidineAlso: ControlIntravenous dexmedetomidine will be administered 45 minutes before extubation in intervention group | Drug | Control group, Dexmedetomidine group |
Primary outcome
Riker sedation-agitation score
Time frame: 60 minutes
Assessment of emergence delirium after extubation. It has numbers from 1-7.
4 secondary outcomes
Postoperative pain score
Time frame: 60 minutes
Opioid consumption
Time frame: 60 minutes
Adverse events
Time frame: 60 minutes
Duration of stay in PACU
Time frame: 60 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 4 Apr 2023.
- Individual participant dataSharing planned: Yes
Related trials for Postoperative Delirium
RecruitingObservational study
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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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.
Anwar Huda, FRCA principal investigator
Security Forces Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Postoperative Delirium, run by Security Forces Hospital at 1 site in Saudi Arabia.
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 1 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 4 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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 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?
Riker sedation-agitation score (time frame: 60 minutes). 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 4 Apr 2023.