Emergence AgitationNCT04485273
Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery
A study testing Laryngeal Mask Airway, Sevoflurane and Subtenon's Block in people with Emergence Agitation, run by Sameh Fathy at 1 site in Egypt.
Trial summary
The study is conducted to evaluate the effects of dexmedetomedine in subtenon's block in conjunction to general anesthesia under sevoflurane anesthesia on emergence agitation, intraoperative hemodynamic stability, postoperative pain, nausea and vomiting in patients undergoing strabismus surgery. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Laryngeal Mask Airway, Sevoflurane and Subtenon's Block
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 1 Dec 2021
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for strabismus surgery.
Who cannot join
- Parental refusal of consent.
- Contraindication to use of supraglottic airway device as gastroesophageal reflux and oropharyngeal pathology.
- Hyperactive airway disease or respiratory diseases.
- Children with developmental delays, mental or neurological disorders.
- Bleeding or coagulation diathesis.
- History of known sensitivity to the used anesthetics.
- Previous surgery in the same eye
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery Under Sevoflurane Anesthesia
The study is conducted to evaluate the effects of dexmedetomedine in subtenon's block in conjunction to general anesthesia under sevoflurane anesthesia on emergence agitation, intraoperative hemodynamic stability, postoperative pain, nausea and vomiting in patients undergoing strabismus surgery.
Read the detailed description
Emergency agitation is a clinical status of postoperative excitement or emergence delirium when the patient is awake but is disorientated. It is described as mental disturbances that consist of confusion, hallucinations and delusions which is manifested by restless involuntary physical activity and thrashing about the bed. Its incidence has been observed especially in pediatric ophthalmology care units due to many factors such as pain, mental status, time of operation, age, lack of ability to see outside, and a history of previous hyperthermia. Strabismus surgery is one of the most frequently performed pediatric ocular operations. However, it can cause unfavorable side effects during intraoperative and postoperative periods. Typically, the major problems associated with strabismus surgeries include increased risk of the oculocardiac reflex, postoperative pain, nausea and vomiting. Subtenon's block is one of the regional anesthetic techniques used in ocular surgery. Dexmedetomidine has been used as an adjuvant to local anesthetics for regional anesthesia in various clinical fields including the subtenon's block.There is evidence that dexmedetomidine decreases the incidence of agitation after sevoflurane anesthesia in children undergoing different surgical procedures. Therefore, this study is conducted to evaluate the effect of dexmedetomedine in subtenon's block on emergence agitation in pediatric strabismus surgery under sevoflurane anesthesia.
This prospective, randomized, clinical study includes 100 children who are scheduled for elective strabismus surgery under general surgery in Mansoura ophthalmology center. Informed written consent is obtained from parents of all subjects in the study after ensuring confidentiality.The study protocol is explained to parents of all patients in the study who are kept fasting prior to surgery. Patients are randomly assigned to two equal groups according to computer-generated table of random numbers using the permuted block randomization method.The collected data are coded, processed, and analyzed using SPSS program. All data are considered statistically significant if P value is ≤ 0.05.
- Conditions
- Emergence Agitation
- Being tested
- Laryngeal Mask Airway, Sevoflurane, Subtenon's Block, Local Anesthetic Solution and Dexmedetomedine, Local Anesthetic Solution
- Keywords
- Dexmedetomedine, Subtenon's Block
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal Mask AirwayDevice
Also called Supraglottic Airway Device
Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation and oral airway tolerance; its size is chosen according to the body weight of the child.
SevofluraneDrug
Also called Inhalational Anesthesia
Sevoflurane in air/oxygen mixture of 40% is titrated to achieve adequate depth of anesthesia.
Subtenon's BlockProcedure or surgery
Also called Regional Eye Block
Subtenon's block is performed in the eye undergoing surgery under sterile conditions where a 19-gauge curved blunt metallic cannula (25 mm) is inserted into sub-tenon's space.
Local Anesthetic Solution and DexmedetomedineDrug
Also called Marcaine and Precedex
The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg), in addition to dexmedetomedine (0.5 μg /kg)
Local Anesthetic SolutionDrug
Also called Marcaine
The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg).
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomedine Group | Active comparator | Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected, in addition to dexmedetomedine. Receives: Device: Laryngeal Mask Airway; Drug: Sevoflurane; Procedure: Subtenon's Block; Drug: Local Anesthetic Solution and Dexmedetomedine |
| Control Group | Placebo comparator | Laryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected. Receives: Device: Laryngeal Mask Airway; Drug: Sevoflurane; Procedure: Subtenon's Block; Drug: Local Anesthetic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postoperative emergence agitation scale
Agitation is assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes.(1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)
Measured: Up to 30 minutes after surgery
Emergence time
Emergence time (min) is recorded; from the discontinuation of sevoflurane to the first response on verbal command.
Measured: Up to 30 minutes after surgery
Secondary outcomes (7)
Changes in heart rate
Heart rate (beat/min) is recorded at five-minute intervals until the end of the surgery.
Measured: Up to the end of the surgery
Changes in mean arterial blood pressure
Blood pressure (mmHg) is recorded at five-minute intervals until the end of the surgery.
Measured: Up to the end of the surgery
Incidence of oculocardiac reflex
If there is dysrhythmia or rapid reduction in HR by more than 25% from the baseline, it is considered as an oculocardiac reflex.
Measured: Up to the end of the surgery
Changes in pain scores
Pain score from 0 to 10 (0 = no pain and 10 = the worst imaginable pain) is assessed every two hours up to 24 hours after the procedure.
Measured: Up to 24 hours after the procedure
Total analgesic requirements of paracetamol
The amount of paracetamol consumption given as a rescue analgesia to patients is measured all over the 24 hours.
Measured: Up to 24 hours after the procedure
First analgesic request
The time of the first analgesic request for paracetamol is recorded.
Measured: Up to 24 hours after the procedure
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting is assessed up to 24 hours after the procedure.
Measured: Up to 24 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jul 2019
- Primary completion1 Jan 2021
- Study completion1 Dec 2021
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sameh Fathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameh Fathy, Mansoura University
- Investigators
- Sameh M El-Sherbiny, MD, Principal investigator, Mansoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485273
- Sponsor's protocol ID
- Dexmedetomedine and agitation
- Status last verified
- Jun 2022
- First submitted
- 21 Jul 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomedine in Subtenon's Block on Emergence Agitation in Pediatric Strabismus Surgery Under Sevoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT04485273
- Acronym / sponsor ID
- Dexmedetomedine and agitation
- Conditions
- Emergence Agitation
- Keywords
- Dexmedetomedine, Subtenon's Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sameh FathyUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 24 Jul 2020 (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 study is conducted to evaluate the effects of dexmedetomedine in subtenon's block in conjunction to general anesthesia under sevoflurane anesthesia on emergence agitation, intraoperative hemodynamic stability, postoperative pain, nausea and vomiting in patients undergoing strabismus surgery.
Detailed description
Emergency agitation is a clinical status of postoperative excitement or emergence delirium when the patient is awake but is disorientated. It is described as mental disturbances that consist of confusion, hallucinations and delusions which is manifested by restless involuntary physical activity and thrashing about the bed. Its incidence has been observed especially in pediatric ophthalmology care units due to many factors such as pain, mental status, time of operation, age, lack of ability to see outside, and a history of previous hyperthermia. Strabismus surgery is one of the most frequently performed pediatric ocular operations. However, it can cause unfavorable side effects during intraoperative and postoperative periods. Typically, the major problems associated with strabismus surgeries include increased risk of the oculocardiac reflex, postoperative pain, nausea and vomiting. Subtenon's block is one of the regional anesthetic techniques used in ocular surgery. Dexmedetomidine has been used as an adjuvant to local anesthetics for regional anesthesia in various clinical fields including the subtenon's block.There is evidence that dexmedetomidine decreases the incidence of agitation after sevoflurane anesthesia in children undergoing different surgical procedures. Therefore, this study is conducted to evaluate the effect of dexmedetomedine in subtenon's block on emergence agitation in pediatric strabismus surgery under sevoflurane anesthesia.
This prospective, randomized, clinical study includes 100 children who are scheduled for elective strabismus surgery under general surgery in Mansoura ophthalmology center. Informed written consent is obtained from parents of all subjects in the study after ensuring confidentiality.The study protocol is explained to parents of all patients in the study who are kept fasting prior to surgery. Patients are randomly assigned to two equal groups according to computer-generated table of random numbers using the permuted block randomization method.The collected data are coded, processed, and analyzed using SPSS program. All data are considered statistically significant if P value is ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomedine Group | Active comparator | Device: Laryngeal Mask Airway, Drug: Sevoflurane, Procedure: Subtenon's Block, Drug: Local Anesthetic Solution and DexmedetomedineLaryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected, in addition to dexmedetomedine. |
| Control Group | Placebo comparator | Device: Laryngeal Mask Airway, Drug: Sevoflurane, Procedure: Subtenon's Block, Drug: Local Anesthetic SolutionLaryngeal mask airway is inserted and anesthesia is maintained with sevoflurane. Subtenon's block is performed and local anesthetic solution is injected. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiology (ASA) I and II patients.
- Scheduled for strabismus surgery.
Key exclusion criteria (7 listed)
- Parental refusal of consent.
- Contraindication to use of supraglottic airway device as gastroesophageal reflux and oropharyngeal pathology.
- Hyperactive airway disease or respiratory diseases.
- Children with developmental delays, mental or neurological disorders.
- Bleeding or coagulation diathesis.
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 |
|---|---|---|
| Laryngeal Mask AirwayAlso: Supraglottic Airway DeviceCapnography connected to laryngeal mask airway is introduced after adequate jaw relaxation and oral airway tolerance; its size is chosen according to the body weight of the child. | Device | Control Group, Dexmedetomedine Group |
| SevofluraneAlso: Inhalational AnesthesiaSevoflurane in air/oxygen mixture of 40% is titrated to achieve adequate depth of anesthesia. | Drug | Control Group, Dexmedetomedine Group |
| Subtenon's BlockAlso: Regional Eye BlockSubtenon's block is performed in the eye undergoing surgery under sterile conditions where a 19-gauge curved blunt metallic cannula (25 mm) is inserted into sub-tenon's space. | Procedure or surgery | Control Group, Dexmedetomedine Group |
| Local Anesthetic Solution and DexmedetomedineAlso: Marcaine and PrecedexThe local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg), in addition to dexmedetomedine (0.5 μg /kg) | Drug | Dexmedetomedine Group |
| Local Anesthetic SolutionAlso: MarcaineThe local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg). | Drug | Control Group |
Primary outcome
Changes in postoperative emergence agitation scale
Time frame: Up to 30 minutes after surgery
Agitation is assessed using the 5- step Cravero scale (1-5) every five minutes from awakening and for 30 minutes.(1:Obtunded with no response to stimulation, 2:Asleep but responsive to movement or stimulation, 3:Awake and responsive, 4:Crying, 5:Thrashing behaviour that requires restraint)
Emergence time
Time frame: Up to 30 minutes after surgery
Emergence time (min) is recorded; from the discontinuation of sevoflurane to the first response on verbal command.
7 secondary outcomes
Changes in heart rate
Time frame: Up to the end of the surgery
Changes in mean arterial blood pressure
Time frame: Up to the end of the surgery
Incidence of oculocardiac reflex
Time frame: Up to the end of the surgery
Changes in pain scores
Time frame: Up to 24 hours after the procedure
Total analgesic requirements of paracetamol
Time frame: Up to 24 hours after the procedure
First analgesic request
Time frame: Up to 24 hours after the procedure
Incidence of postoperative nausea and vomiting
Time frame: Up to 24 hours after the procedure
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 22 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Emergence Agitation
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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
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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.
Sameh M El-Sherbiny, MD principal investigator
Mansoura Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngeal Mask Airway, Sevoflurane and Subtenon's Block in people with Emergence Agitation, run by Sameh Fathy 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 2 inclusion and 7 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 22 Jun 2022. 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?
Changes in postoperative emergence agitation scale (time frame: Up to 30 minutes after surgery). 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 22 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.