Emergence AgitationagitationNCT06539013
Efficacy of Remifentanil in Preventing Emergence Agitation
A study testing Remifentanil, N2O and Fentanyl in people with Emergence Agitation, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of the study was to test the hypothesis that remifentanil administered for analgesia prevents emergence agitation more effectively than fentanyl and N2O in patients undergoing rhinoplasty who received desflurane as an inhaled anesthetic agent. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Remifentanil, N2O and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Oct 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The study included patients over the age of 18, planned to undergo rhinoplasty by the plastic and reconstructive surgery department, and American Society of Anesthesiologist (ASA) I-II.
- -
Who cannot join
- Patients with a known history of allergy to the drugs to be administered in the study, ASA III and above, body mass index (BMI) 35>kg/m2, younger than 18 years of age, any problems that would prevent general anesthesia in the preoperative evaluation (upper respiratory tract infection, etc.), and those who did not agree to participate in the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Health Sciences University Gazi Yaşargil Training and Research Hospital
Diyarbakır, Kayapınar, 21070
Hülya Tosun Söner, doctor, +905352792102, hulyatosunsoner@hotmail.com
About this study
Official title: Efficacy of Remifentanil in Preventing Emergence Agitation in Patients Undergoing Nasal Surgery Under Desflurane Anesthesia: A Prospective Double-blind Randomized Controlled Trial.
The primary aim of the study was to test the hypothesis that remifentanil administered for analgesia prevents emergence agitation more effectively than fentanyl and N2O in patients undergoing rhinoplasty who received desflurane as an inhaled anesthetic agent. The secondary aim of the study was to compare the demographic data, intraoperative and postoperative hemodynamic data, surgical time and modified Aldrete score of patients who received different intraoperative analgesia methods.
- Conditions
- Emergence Agitation
- Being tested
- Remifentanil, N2O, Fentanyl
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Use of remifentanil infusion for analgesia
remifentanil infusion
N2ODrug
Also called Use of N2O for analgesia
Use of N2O for analgesia
FentanylDrug
Also called Use of Fentanyl for analgesia
Use of Fentanylfor analgesia
| Study group | Role | What they receive |
|---|---|---|
| group 1 Remifentanily | Active comparator | Patients in Group 1 received 0.05-0.2 μg/kg/min IV remifentanil infusion as analgesic. Receives: Drug: Remifentanil |
| group 2 N2O | Active comparator | N2O instead of 50% air was applied to patients in Group 2 for intraoperative analgesia. Receives: Drug: N2O |
| group 3 Fentanly | Active comparator | In addition to Desflurane, 50% oxygen and 50% air, 1 μg/kg IV fentanyl bolus was administered as analgesic when there was a 20% increase in heart rate and blood pressure values during the operation for patients in Group 3. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Richmond Agitation-Sedation Scale (RASS)
- 4 Combative, violent, danger to staff
- 3 Pulls or removes tube(s) or catheters; aggressive
- 2 Frequent non-purposeful movement, fights ventilator
- 1 Anxious, apprehensive, but not aggressive 0 Alert and calm
- 1 Awakens to voice (eye opening/contact) > 10 seconds
- 2 Light sedation; briefly awakens to voice (eye opening/contant) < 10 seconds
- 3 Moderate sedation; movement or eye opening. No eye contact
- 4 Deep sedation; no response to voice, but movement or eye opening to physical stimulation
- 5 Unarousable; no response to voice or physical stimulation
Measured: Postoperative care unit 1.second_5. second_15.second
Secondary outcomes (2)
mean arterial pressure
mmHg
Measured: Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min
Heart rate
beats/min
Measured: Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Aug 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hülya Tosun Söner, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539013
- Sponsor's protocol ID
- HTosunSONE
- Acronym
- agitation
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Remifentanil in Preventing Emergence Agitation in Patients Undergoing Nasal Surgery Under Desflurane Anesthesia: A Prospective Double-blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06539013
- Acronym / sponsor ID
- agitation / HTosunSONE
- Conditions
- Emergence Agitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 6 Aug 2024 (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.
The primary aim of the study was to test the hypothesis that remifentanil administered for analgesia prevents emergence agitation more effectively than fentanyl and N2O in patients undergoing rhinoplasty who received desflurane as an inhaled anesthetic agent. The secondary aim of the study was to compare the demographic data, intraoperative and postoperative hemodynamic data, surgical time and modified Aldrete score of patients who received different intraoperative analgesia methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 Remifentanily | Active comparator | Drug: RemifentanilPatients in Group 1 received 0.05-0.2 μg/kg/min IV remifentanil infusion as analgesic. |
| group 2 N2O | Active comparator | Drug: N2ON2O instead of 50% air was applied to patients in Group 2 for intraoperative analgesia. |
| group 3 Fentanly | Active comparator | Drug: FentanylIn addition to Desflurane, 50% oxygen and 50% air, 1 μg/kg IV fentanyl bolus was administered as analgesic when there was a 20% increase in heart rate and blood pressure values during the operation for patients in Group 3. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The study included patients over the age of 18, planned to undergo rhinoplasty by the plastic and reconstructive surgery department, and American Society of Anesthesiologist (ASA) I-II.
- -
Key exclusion criteria (1 listed)
- Patients with a known history of allergy to the drugs to be administered in the study, ASA III and above, body mass index (BMI) 35>kg/m2, younger than 18 years of age, any problems that would prevent general anesthesia in the preoperative evaluation (upper respiratory tract infection, etc.), and those who did not agree to participate in the study were excluded from 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 |
|---|---|---|
| RemifentanilAlso: Use of remifentanil infusion for analgesiaremifentanil infusion | Drug | group 1 Remifentanily |
| N2OAlso: Use of N2O for analgesiaUse of N2O for analgesia | Drug | group 2 N2O |
| FentanylAlso: Use of Fentanyl for analgesiaUse of Fentanylfor analgesia | Drug | group 3 Fentanly |
Primary outcome
Richmond Agitation-Sedation Scale (RASS)
Time frame: Postoperative care unit 1.second_5. second_15.second
* 4 Combative, violent, danger to staff * 3 Pulls or removes tube(s) or catheters; aggressive * 2 Frequent non-purposeful movement, fights ventilator * 1 Anxious, apprehensive, but not aggressive 0 Alert and calm * 1 Awakens to voice (eye opening/contact) > 10 seconds * 2 Light sedation; briefly awakens to voice (eye opening/contant) < 10 seconds * 3 Moderate sedation; movement or eye opening. No eye contact * 4 Deep sedation; no response to voice, but movement or eye opening to physical stimulation * 5 Unarousable; no response to voice or physical stimulation
2 secondary outcomes
mean arterial pressure
Time frame: Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min
Heart rate
Time frame: Before induction ,After intubation 1 min,After intubation 5 min, After intubation 15 min After intubation 30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
Related trials for Emergence Agitation
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruiting
Intranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy
Emergence Agitation, Vocal Cord Polyps
Not yet recruitingPhase 3
Effect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy
Emergence Agitation, Emergence Delirium
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil, N2O and Fentanyl in people with Emergence Agitation, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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 Turkey (Türkiye). 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.
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 Hülya Tosun Söner (+905352792102, hulyatosunsoner@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Richmond Agitation-Sedation Scale (RASS) (time frame: Postoperative care unit 1.second_5. second_15.second). 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 6 Aug 2024.