Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General AnesthesiaNCT03427502
Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation
A study testing Bupivacaine-epinephrine and normal saline in people with Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General Anesthesia and Deviated Nasal Septum, run by Lumbini Medical College at 1 site in Nepal.
Trial summary
Postoperative agitation is an important complication of general anesthesia, moreover, it has been found with high incidence in ear, nose, throat (ENT) surgeries. We aim to study whether anterior ethmoidal nerve block will be successful in reducing postoperative agitation in those patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General Anesthesia, Deviated Nasal Septum, Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Bupivacaine-epinephrine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jun 2018to 28 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing nasal surgery
- Under General Anesthesia
- With nasal packs
Who cannot join
- Do not consent to the study.
- History of allergy to lignocaine or bupivacaine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries With Nasal Packs Under General Anesthesia: A Double Blind Randomized Control Trial
Postoperative agitation is an important complication of general anesthesia, moreover, it has been found with high incidence in ear, nose, throat (ENT) surgeries. We aim to study whether anterior ethmoidal nerve block will be successful in reducing postoperative agitation in those patients. Study population will be randomized into two groups, treatment and control group. Anterior ethmoidal nerve block will be done in treatment group and postoperative agitation compared between these two groups. Agitation score will be scored with Riker Sedation-Agitation Scale (SAS).
Ho: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is equal in those with ethmoidal nerve block as compared to those without the block.
Ha: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is not equal in those with ethmoidal nerve block as compared to those without the block.
- Conditions
- Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General Anesthesia, Deviated Nasal Septum, Chronic Rhinosinusitis (Diagnosis), Nasal Polyps
- Being tested
- Bupivacaine-epinephrine, normal saline
- Keywords
- general anesthesia, nasal surgery, anterior ehtmoidal nerve block, bupivacaine, postoperative confusion
- Medical subject headings
- Confusion, Disease, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-epinephrineDrug
10 ml of 0.5% bupivacaine with 1:2,00,000 adrenaline. For children less than 12 years of age, 0.25% bupivacaine with 1:2,00,000 adrenaline
normal salineDrug
normal saline
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Experimental: Study Group At the end of surgery before nasal packing, scrub nurse will prepare 10 ml solution 0.5% bupivacaine with 1:2,00,000 adrenaline in a syringe and pass it over to the operating surgeon. The surgeon will block anterior ethmoidal nerve.
Injection technique: External nasal nerve will be blocked through an inter-cartilaginous injection into the dorsum of the nose.
Internal nasal nerve will be blocked in septum and lateral wall of nose. Septal block is done in upper anterior part of nasal septum. Three injections will be given on lateral nasal wall. First injection will be given just antero-superior to the attachment of middle turbinate (axilla). Second injection will be given at the anterior end of middle turbinate and third injection at the medial surface of middle turbinate. Withdrawal of injection will be done prior to deposition of solution every time to ensure that the solution is not deposited directly into a blood vessel. Receives: Drug: Bupivacaine-epinephrine |
| Control Group | Placebo comparator | At the end of surgery before nasal packing, scrub nurse will pass 10 ml of normal saline in a syringe to the surgeron.
Injection technique remains the same as in Study group. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative agitation
It will be assessed with Riker Sedation-Agitation Scale (SAS). It is a Likert scale with scores from 1 to 7 where 1 indicates unarousable (Minimal or no response to noxious stimuli, does not communicate or follow commands) and 7 indicates Dangerous agitation (Pulling at ET tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side). A higher value indicates worse outcome.
Measured: After extubation before leaving operation table, an average of 10 minutes
Postoperative agitation
It will be assessed with Riker Sedation-Agitation Scale (SAS). It is a Likert scale with scores from 1 to 7 where 1 indicates unarousable (Minimal or no response to noxious stimuli, does not communicate or follow commands) and 7 indicates Dangerous agitation (Pulling at ET tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side). A higher value indicates worse outcome.
Measured: 30 minutes after first score.
Postoperative agitation
It will be assessed with Riker Sedation-Agitation Scale (SAS)
Measured: 9:00 AM next morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Jun 2018
- Primary completion30 Dec 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General AnesthesiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumbini Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427502
- Sponsor's protocol ID
- 139
- Status last verified
- Sep 2020
- First submitted
- 2 Feb 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data except patients name and address may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Ethmoidal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries With Nasal Packs Under General Anesthesia: A Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03427502
- Acronym / sponsor ID
- 139
- Conditions
- Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General Anesthesia, Deviated Nasal Septum, Chronic Rhinosinusitis (Diagnosis), Nasal Polyps
- Keywords
- general anesthesia, nasal surgery, anterior ehtmoidal nerve block, bupivacaine, postoperative confusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lumbini Medical CollegeUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 9 Feb 2018 (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.
Postoperative agitation is an important complication of general anesthesia, moreover, it has been found with high incidence in ear, nose, throat (ENT) surgeries. We aim to study whether anterior ethmoidal nerve block will be successful in reducing postoperative agitation in those patients. Study population will be randomized into two groups, treatment and control group. Anterior ethmoidal nerve block will be done in treatment group and postoperative agitation compared between these two groups. Agitation score will be scored with Riker Sedation-Agitation Scale (SAS).
Ho: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is equal in those with ethmoidal nerve block as compared to those without the block.
Ha: Occurrence of post-operative agitation in patients undergoing nasal surgery with nasal pack under general anesthesia is not equal in those with ethmoidal nerve block as compared to those without the block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Bupivacaine-epinephrineExperimental: Study Group At the end of surgery before nasal packing, scrub nurse will prepare 10 ml solution 0.5% bupivacaine with 1:2,00,000 adrenaline in a syringe and pass it over to the operating surgeon. The surgeon will block anterior ethmoidal nerve. Injection technique: External nasal nerve will be blocked through an inter-cartilaginous injection into the dorsum of the nose. Internal nasal nerve will be blocked in septum and lateral wall of nose. Septal block is done in upper anterior part of nasal septum. Three injections will be given on lateral nasal wall. First injection will be given just antero-superior to the attachment of middle turbinate (axilla). Second injection will be given at the anterior end of middle turbinate and third injection at the medial surface of middle turbinate. Withdrawal of injection will be done prior to deposition of solution every time to ensure that the solution is not deposited directly into a blood vessel. |
| Control Group | Placebo comparator | Drug: normal salineAt the end of surgery before nasal packing, scrub nurse will pass 10 ml of normal saline in a syringe to the surgeron. Injection technique remains the same as in Study group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing nasal surgery
- Under General Anesthesia
- With nasal packs
Key exclusion criteria (2 listed)
- Do not consent to the study.
- History of allergy to lignocaine or bupivacaine
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-epinephrine10 ml of 0.5% bupivacaine with 1:2,00,000 adrenaline. For children less than 12 years of age, 0.25% bupivacaine with 1:2,00,000 adrenaline | Drug | Study Group |
| normal salinenormal saline | Drug | Control Group |
Primary outcome
Postoperative agitation
Time frame: After extubation before leaving operation table, an average of 10 minutes
It will be assessed with Riker Sedation-Agitation Scale (SAS). It is a Likert scale with scores from 1 to 7 where 1 indicates unarousable (Minimal or no response to noxious stimuli, does not communicate or follow commands) and 7 indicates Dangerous agitation (Pulling at ET tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side). A higher value indicates worse outcome.
Postoperative agitation
Time frame: 30 minutes after first score.
It will be assessed with Riker Sedation-Agitation Scale (SAS). It is a Likert scale with scores from 1 to 7 where 1 indicates unarousable (Minimal or no response to noxious stimuli, does not communicate or follow commands) and 7 indicates Dangerous agitation (Pulling at ET tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side). A higher value indicates worse outcome.
Postoperative agitation
Time frame: 9:00 AM next morning
It will be assessed with Riker Sedation-Agitation Scale (SAS)
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 11 Sep 2020.
- Individual participant dataSharing planned: Undecided. All data except patients name and address may be shared.
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-epinephrine and normal saline in people with Postoperative Agitation: Impaired Awareness, Abnormal Cognitive Function, Confusion, and Verbal and Physical Agitation During Recovery From General Anesthesia and Deviated Nasal Septum, run by Lumbini Medical College at 1 site in Nepal.
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 11 Sep 2020. 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 Nepal. 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 agitation (time frame: After extubation before leaving operation table, an average of 10 minutes). The study lists 3 primary outcomes in all. 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 11 Sep 2020.