Agitation States as Acute Reaction to Gross StressNCT03069027
Efficacy of External Nasal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries
A study testing External nasal nerve block, saline adrenaline and Xylocaine, adrenaline in people with Agitation States as Acute Reaction to Gross Stress, run by Al Jedaani Hospital at 1 site in Saudi Arabia.
Trial summary
Emergence agitation following general anaesthesia may lead to serious complications like self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia, bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence agitation. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Agitation States as Acute Reaction to Gross Stress
- What is being tested?
- External nasal nerve block, saline adrenaline and Xylocaine, adrenaline
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Aug 2016to 1 Jul 2017
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 110 adult patients of ASA physical status I and II,
- Age 20-60 years,
- Scheduled for elective external nasal surgeries in which nasal packing on each side was used postoperatively for 24 hours.
Who cannot join
- History of uncontrolled hypertension,
- Ischemic or valvular heart disease,
- Use of MAO inhibitors or adrenergic blocking drugs,
- Cognitive impairment,
- Patients taking antipsychotics,
- Renal insufficiency or liver dysfunction
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Al Jedaani group of hospitals
Jeddah, Meccah, 21462/7500
About this study
Official title: Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial
Emergence agitation following general anaesthesia may lead to serious complications like self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia, bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence agitation. The investigators planned to evaluate the efficacy of external nasal nerve block in prevention of postoperative agitation following external nasal surgeries under general anesthesia(GA).
- Being tested
- External nasal nerve block, saline adrenaline, Xylocaine, adrenaline
- Keywords
- Nasal surgery, external nasal nerve block, postoperative agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External nasal nerve blockProcedure or surgery
Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.
saline adrenalineDrug
Xylocaine, adrenalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Group I(control) | Placebo comparator | patients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo) Receives: Procedure: External nasal nerve block; Drug: saline adrenaline |
| Group II(block) | Active comparator | 'External nasal nerve block by Xylocaine, adrenaline' Receives: Procedure: External nasal nerve block; Drug: Xylocaine, adrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative agitation
Assessment done using Richmond agitation- sedation scale (RASS)
Measured: Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.
Quality of recovery
Quality of recovery
Measured: 24 hours postoperative
Secondary outcomes (7)
dose of fentanyl
Fentanyl boluses were given in response to changes in hemodynamics (more than 15% increases in MAP and HR than the baseline values taken after induction by 5 minutes)
Measured: intraoperative period in minutes
morphine dose in PACU
equivalent morphine dose in PACU (calculated using opioid:morphine equivalents of 100 µg i.v. fentanyl to 10 mg i.v. morphine; 75- 100 mg IV pethidine to 10 mg i.v. morphine
Measured: one hour in PACU
Nausea and vomiting in PACU
Four-point nausea and vomiting scale (0=no nausea; 1=mild nausea; 2=severe nausea requiring antiemetics; and 3=retching, vomiting, or both) was also evaluated
Measured: one hour in PACU
Extubation time
Measured: Up to 15 after discontinuation of anesthesia
Surgical time
intraoperative
Measured: duration of surgery in minutes up to 3 hours
first verbal response time
period from discontinuation of anesthesia 'time zero' to 1st verbal response in minutes
Measured: up to 15 minutes
complication of nasal block
including local anesthetic systemic toxicity, vascular injury, intravascular injection of local anesthetic, and local hematoma.
Measured: From injection to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start15 Aug 2016
- Primary completion15 Apr 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation States as Acute Reaction to Gross StressStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al Jedaani Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mohamed Ibrahim, Al Jedaani Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069027
- Sponsor's protocol ID
- 3-2-17
- Status last verified
- Dec 2017
- First submitted
- 19 Feb 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03069027
- Acronym / sponsor ID
- 3-2-17
- Keywords
- Nasal surgery, external nasal nerve block, postoperative agitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al Jedaani HospitalUniversity, hospital or other
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 3 Mar 2017 (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.
Emergence agitation following general anaesthesia may lead to serious complications like self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia, bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence agitation. The investigators planned to evaluate the efficacy of external nasal nerve block in prevention of postoperative agitation following external nasal surgeries under general anesthesia(GA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I(control) | Placebo comparator | Procedure: External nasal nerve block, Drug: saline adrenalinepatients allocated for external nasal nerve block with saline adrenaline 1/200,000 (placebo) |
| Group II(block) | Active comparator | Procedure: External nasal nerve block, Drug: Xylocaine, adrenaline'External nasal nerve block by Xylocaine, adrenaline' |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 110 adult patients of ASA physical status I and II,
- Age 20-60 years,
- Scheduled for elective external nasal surgeries in which nasal packing on each side was used postoperatively for 24 hours.
Key exclusion criteria (6 listed)
- History of uncontrolled hypertension,
- Ischemic or valvular heart disease,
- Use of MAO inhibitors or adrenergic blocking drugs,
- Cognitive impairment,
- Patients taking antipsychotics,
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 |
|---|---|---|
| External nasal nerve blockThree single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation. | Procedure or surgery | Group I(control), Group II(block) |
| saline adrenaline | Drug | Group I(control) |
| Xylocaine, adrenaline | Drug | Group II(block) |
Primary outcome
postoperative agitation
Time frame: Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.
Assessment done using Richmond agitation- sedation scale (RASS)
Quality of recovery
Time frame: 24 hours postoperative
Quality of recovery
7 secondary outcomes
dose of fentanyl
Time frame: intraoperative period in minutes
morphine dose in PACU
Time frame: one hour in PACU
Nausea and vomiting in PACU
Time frame: one hour in PACU
Extubation time
Time frame: Up to 15 after discontinuation of anesthesia
Surgical time
Time frame: duration of surgery in minutes up to 3 hours
first verbal response time
Time frame: up to 15 minutes
complication of nasal block
Time frame: From injection to 24 hours postoperative
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 27 Dec 2017.
- Individual participant dataSharing planned: Undecided
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 External nasal nerve block, saline adrenaline and Xylocaine, adrenaline in people with Agitation States as Acute Reaction to Gross Stress, run by Al Jedaani 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 3 inclusion and 6 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 27 Dec 2017. 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.
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: Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.). The study lists 2 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 27 Dec 2017.