Emergence AgitationNCT04168879
Sphenopalatine Ganglion Block for Nasal Surery
A study testing Bupivacaine 0.5% Preservative-Free Injectable Solution and normal saline in people with Emergence Agitation, run by Assiut University at 1 site in Egypt.
Trial summary
nasal surgery carries many perioperative challenges, intraoperative bleeing and its effect on surgical field i the main intraoperative concern an postoperative agitation and its serious complications is the main postoperative challenge. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Bupivacaine 0.5% Preservative-Free Injectable Solution and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2021to 10 Dec 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patient written consent
- elective surgery
- age 18 - 55 year old
Who cannot join
- patient refusal
- emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Suprazygomatic Approach of Sphenopalatine Ganglion Block for Nasal Surery
nasal surgery carries many perioperative challenges, intraoperative bleeing and its effect on surgical field i the main intraoperative concern an postoperative agitation and its serious complications is the main postoperative challenge.
- Conditions
- Emergence Agitation
- Being tested
- Bupivacaine 0.5% Preservative-Free Injectable Solution, normal saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.5% Preservative-Free Injectable SolutionDrug
1.5 ml of Bupivacaine 0.5% Preservative-Free Injectable Solution used to block the sphenopalatine ganglion by ultrasound guided suprazygomatic approach
normal salineDrug
1.5 ml of normal saline is delivered to the sphenopalatine ganglion by ultrasound guided suprazygomatic approach
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine group | Active comparator | Not described Receives: Drug: Bupivacaine 0.5% Preservative-Free Injectable Solution |
| saline group | Placebo comparator | Not described Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative emergence agitation
ramsy hunt sedation agitation score used during emergence from anesthesia
Measured: 2 hour
Secondary outcomes (4)
postoperative opioid consumption
total amount of opioid analgesia in first 24 hours postoperative
Measured: 24 hour
surgical field quality
Boezaart score was be used
Measured: 2 hours
consumed inhalational anesthesia
mean anesthesia MAC intraoperative
Measured: 2 hours
postoperative pain
using VAS ; scale from 0 to 10 . where 0 is no pain and 10 is worst pain
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start10 Nov 2021
- Primary completion10 Dec 2023
- Study completion10 Dec 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 Emergence AgitationStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- saeid metwaly abouelyazid elsawy
- Responsible party
- Principal investigator, Rasha Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168879
- Sponsor's protocol ID
- ACCA
- Status last verified
- May 2024
- First submitted
- 16 Nov 2019
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamed R, Gamal L, Elsawy S, Baker MA, Abbas YH. Efficacy of ultrasound guided sphenopalatine ganglion block in management of emergence agitation after sinoscopic nasal surgery: a randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101429. doi: 10.1016/j.accpm.2024.101429. Epub 2024 Oct 2.
PubMed 39366653
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Suprazygomatic Approach of Sphenopalatine Ganglion Block for Nasal Surery
- ClinicalTrials.gov ID
- NCT04168879
- Acronym / sponsor ID
- ACCA
- Conditions
- Emergence Agitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- saeid metwaly abouelyazid elsawy
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 19 Nov 2019 (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.
nasal surgery carries many perioperative challenges, intraoperative bleeing and its effect on surgical field i the main intraoperative concern an postoperative agitation and its serious complications is the main postoperative challenge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine group | Active comparator | Drug: Bupivacaine 0.5% Preservative-Free Injectable Solution |
| saline group | Placebo comparator | Drug: normal saline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patient written consent
- elective surgery
- age 18 - 55 year old
Key exclusion criteria (2 listed)
- patient refusal
- emergency surgery
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 |
|---|---|---|
| Bupivacaine 0.5% Preservative-Free Injectable Solution1.5 ml of Bupivacaine 0.5% Preservative-Free Injectable Solution used to block the sphenopalatine ganglion by ultrasound guided suprazygomatic approach | Drug | bupivacaine group |
| normal saline1.5 ml of normal saline is delivered to the sphenopalatine ganglion by ultrasound guided suprazygomatic approach | Drug | saline group |
Primary outcome
Postoperative emergence agitation
Time frame: 2 hour
ramsy hunt sedation agitation score used during emergence from anesthesia
4 secondary outcomes
postoperative opioid consumption
Time frame: 24 hour
surgical field quality
Time frame: 2 hours
consumed inhalational anesthesia
Time frame: 2 hours
postoperative pain
Time frame: 2 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 28 May 2024.
- Derived from this study: PubMed 39366653Hamed R, Gamal L, Elsawy S, Baker MA, Abbas YH. Efficacy of ultrasound guided sphenopalatine ganglion block in management of emergence agitation after sinoscopic nasal surgery: a randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101429. doi: 10.1016/j.accpm.2024.101429. Epub 2024 Oct 2.
- Individual participant dataSharing planned: No
Related trials for Emergence Agitation
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.5% Preservative-Free Injectable Solution and normal saline in people with Emergence Agitation, 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 2 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 28 May 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 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. 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.
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?
Postoperative emergence agitation (time frame: 2 hour). 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 NCT04168879, 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 28 May 2024.