Airway Complication of AnesthesiaNCT05769842
Effects of Propofol on Respiratory Adverse Events During Extubation in Children Undergoing Tonsil Adenoidectomy
A study testing propofol and normal saline in people with Airway Complication of Anesthesia, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The main objective of this study was to investigate whether propofol assisted extubation could reduce the incidence of respiratory adverse events in children with tonsil adenoidectomy. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Airway Complication of Anesthesia
- What is being tested?
- propofol and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Jan 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age: 3~8 years old,
- general anesthesia for tracheal intubation in ASA Grade I to III patients undergoing tonsil adenoidectomy,
- the operation time is 10~60 minutes,
- sign informed consent.
Who cannot join
- patients with congenital heart disease, tumor, severe lung disease, liver and kidney function disease, nervous system disease, coagulation dysfunction, etc,
- children who do not consent to the test.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital affiliated with Fudan University
Shanghai, 201102
About this study
Official title: Can Propofol Reduce Respiratory Adverse Events During Extubation in Children With Tonsillectomy? A Prospective Randomized Controlled Study
The main objective of this study was to investigate whether propofol assisted extubation could reduce the incidence of respiratory adverse events in children with tonsil adenoidectomy.
Read the detailed description
In pediatric surgery, the incidence of perioperative respiratory adverse events in children undergoing tonsillectomy is higher than that of general surgery. Studies have shown that intravenous induction can reduce perioperative respiratory adverse events compared with inhalation induction. There are also literatures that show that intravenous anesthesia can significantly reduce cough and hemodynamic reactions during the wake period compared with balanced anesthesia.However, inhalation anesthesia is easier to use and can monitor the depth of anesthesia, so it is used more frequently than intravenous anesthesia.The incidence of respiratory adverse events has not been compared between intraoperative sevoflurane maintenance and extubation with a small amount of propofol versus total sevoflurane maintenance and extubation.The objective of this study was to investigate whether propofol can reduce perioperative adverse respiratory events in children undergoing tonsillectomy.
- Conditions
- Airway Complication of Anesthesia
- Being tested
- propofol, normal saline
- Keywords
- propofol, tracheal extubation, respiratory adverse events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called No Other Intervention Names
Propofol was mainly used in the intervention group during anesthesia extubation. Propofol was given a small amount of times about 1~2mg/kg before extubation when the patient recovered spontaneously.
normal salineDrug
Also called No Other Intervention Names
Same dose as propofol.
| Study group | Role | What they receive |
|---|---|---|
| propofol group | Experimental | Children aged 3 to 8 years who had had their tonsil adenoidectomy were collected. Propofol 3mg/kg, remifentanil 3-5ug /kg and atropine 0.01mg/kg were used for intravenous induction intubation. Sevoflurane was used for intraoperative anesthesia, propartamol 30mg/kg and hydromorphone 5-10ug /kg were used for postoperative analgesia.When sevoflurane was shut down at the end of the operation, oxygen flow was increased to more than 7L/min, and extubation was prepared for spontaneous respiration recovery, propofol was given a small amount of 1~2mg/kg multiple times without inhibition of spontaneous respiration. Receives: Drug: propofol |
| control group | Sham comparator | Anesthesia induction is the same as before.At the end of the operation, sevoflurane was shut down and oxygen flow was increased to more than 7L/min. No other treatment was performed during extubation. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
respiratory adverse events
These include six items in total:
- laryngeal spasm: little or no airflow in jaw support,need mask pressure ventilation or anesthetic relief .
- bronchospasm:airway pressure increased, tidal volume decreased, and lung auscultation and wheezing were observed, accompanied by decreased oxygen saturation.
- breath-holding:no breathing time > 5 seconds or more.
- cough:0 = no cough; 1 point = weak cough; 2 points = strong cough; 3 points = continuous strong cough.
- low oxygen saturation:less than 92% on oxygen.
- respiratory obstruction:jaw support is needed for relief.
Measured: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.
Secondary outcomes (2)
extubation time
longer than 15 minutes means longer extubation time.
Measured: No more than three hours from the end of the procedure until the tracheal tube was pulled out.
Richmond Agitation Sedation Scale
The score ranges from -5 to +4. A higher score indicates more agitation and a lower score indicates greater calmness. In this study, a score greater than or equal to 1 indicates agitation.
Measured: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Nov 2023
- Primary completion30 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Model description
- Pediatric patients were randomly assigned to either the propofol group or the control group. In the propofol group, after the child regained spontaneous breathing before extubation, propofol was administered in small repeated doses, each dose being 0.5mg/kg, with a total amount of 1\~2mg/kg. The control group received an equivalent volume of normal saline. The occurrence of respiratory adverse events (such as laryngospasm, bronchospasm, breath-holding, coughing, decreased oxygen saturation, and airway obstruction) was observed in both groups post-extubation, with the presence of any one or more events considered indicative of respiratory adverse events.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhijian Zhou, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769842
- Sponsor's protocol ID
- 2022-01
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramgolam A, Hall GL, Zhang G, Hegarty M, von Ungern-Sternberg BS. Inhalational versus IV induction of anesthesia in children with a high risk of perioperative respiratory adverse events. Anesthesiology. 2018;128(6):1065-1074. AORN J. 2018 Nov;108(5):566-571. doi: 10.1002/aorn.12390. No abstract available.
PubMed 30376178Hohlrieder M, Tiefenthaler W, Klaus H, Gabl M, Kavakebi P, Keller C, Benzer A. Effect of total intravenous anaesthesia and balanced anaesthesia on the frequency of coughing during emergence from the anaesthesia. Br J Anaesth. 2007 Oct;99(4):587-91. doi: 10.1093/bja/aem203. Epub 2007 Jul 27.
PubMed 17660457von Ungern-Sternberg BS, Davies K, Hegarty M, Erb TO, Habre W. The effect of deep vs. awake extubation on respiratory complications in high-risk children undergoing adenotonsillectomy: a randomised controlled trial. Eur J Anaesthesiol. 2013 Sep;30(9):529-36. doi: 10.1097/EJA.0b013e32835df608.
PubMed 23344124Liao R, Zhou Z, Wang X, Shao H. Impact of Propofol Administered before Extubation on Respiratory Adverse Events in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Randomized Controlled Trial. Br J Hosp Med (Lond). 2024 Nov 30;85(11):1-15. doi: 10.12968/hmed.2024.0431. Epub 2024 Nov 18.
PubMed 39618204
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Propofol Reduce Respiratory Adverse Events During Extubation in Children With Tonsillectomy? A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05769842
- Acronym / sponsor ID
- 2022-01
- Conditions
- Airway Complication of Anesthesia
- Keywords
- propofol, tracheal extubation, respiratory adverse events
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 15 Mar 2023 (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 main objective of this study was to investigate whether propofol assisted extubation could reduce the incidence of respiratory adverse events in children with tonsil adenoidectomy.
Detailed description
In pediatric surgery, the incidence of perioperative respiratory adverse events in children undergoing tonsillectomy is higher than that of general surgery. Studies have shown that intravenous induction can reduce perioperative respiratory adverse events compared with inhalation induction. There are also literatures that show that intravenous anesthesia can significantly reduce cough and hemodynamic reactions during the wake period compared with balanced anesthesia.However, inhalation anesthesia is easier to use and can monitor the depth of anesthesia, so it is used more frequently than intravenous anesthesia.The incidence of respiratory adverse events has not been compared between intraoperative sevoflurane maintenance and extubation with a small amount of propofol versus total sevoflurane maintenance and extubation.The objective of this study was to investigate whether propofol can reduce perioperative adverse respiratory events in children undergoing tonsillectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Pediatric patients were randomly assigned to either the propofol group or the control group. In the propofol group, after the child regained spontaneous breathing before extubation, propofol was administered in small repeated doses, each dose being 0.5mg/kg, with a total amount of 1~2mg/kg. The control group received an equivalent volume of normal saline. The occurrence of respiratory adverse events (such as laryngospasm, bronchospasm, breath-holding, coughing, decreased oxygen saturation, and airway obstruction) was observed in both groups post-extubation, with the presence of any one or more events considered indicative of respiratory adverse events.
| Arm | Type | Receives |
|---|---|---|
| propofol group | Experimental | Drug: propofolChildren aged 3 to 8 years who had had their tonsil adenoidectomy were collected. Propofol 3mg/kg, remifentanil 3-5ug /kg and atropine 0.01mg/kg were used for intravenous induction intubation. Sevoflurane was used for intraoperative anesthesia, propartamol 30mg/kg and hydromorphone 5-10ug /kg were used for postoperative analgesia.When sevoflurane was shut down at the end of the operation, oxygen flow was increased to more than 7L/min, and extubation was prepared for spontaneous respiration recovery, propofol was given a small amount of 1~2mg/kg multiple times without inhibition of spontaneous respiration. |
| control group | Sham comparator | Drug: normal salineAnesthesia induction is the same as before.At the end of the operation, sevoflurane was shut down and oxygen flow was increased to more than 7L/min. No other treatment was performed during extubation. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age: 3~8 years old,
- general anesthesia for tracheal intubation in ASA Grade I to III patients undergoing tonsil adenoidectomy,
- the operation time is 10~60 minutes,
- sign informed consent.
Key exclusion criteria (2 listed)
- patients with congenital heart disease, tumor, severe lung disease, liver and kidney function disease, nervous system disease, coagulation dysfunction, etc,
- children who do not consent to the test.
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 |
|---|---|---|
| propofolAlso: No Other Intervention NamesPropofol was mainly used in the intervention group during anesthesia extubation. Propofol was given a small amount of times about 1~2mg/kg before extubation when the patient recovered spontaneously. | Drug | propofol group |
| normal salineAlso: No Other Intervention NamesSame dose as propofol. | Drug | control group |
Primary outcome
respiratory adverse events
Time frame: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.
These include six items in total: 1. laryngeal spasm: little or no airflow in jaw support,need mask pressure ventilation or anesthetic relief . 2. bronchospasm:airway pressure increased, tidal volume decreased, and lung auscultation and wheezing were observed, accompanied by decreased oxygen saturation. 3. breath-holding:no breathing time > 5 seconds or more. 4. cough:0 = no cough; 1 point = weak cough; 2 points = strong cough; 3 points = continuous strong cough. 5. low oxygen saturation:less than 92% on oxygen. 6. respiratory obstruction:jaw support is needed for relief.
2 secondary outcomes
extubation time
Time frame: No more than three hours from the end of the procedure until the tracheal tube was pulled out.
Richmond Agitation Sedation Scale
Time frame: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four 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 5 Feb 2024.
- Background: PubMed 30376178Ramgolam A, Hall GL, Zhang G, Hegarty M, von Ungern-Sternberg BS. Inhalational versus IV induction of anesthesia in children with a high risk of perioperative respiratory adverse events. Anesthesiology. 2018;128(6):1065-1074. AORN J. 2018 Nov;108(5):566-571. doi: 10.1002/aorn.12390. No abstract available.
- Background: PubMed 17660457Hohlrieder M, Tiefenthaler W, Klaus H, Gabl M, Kavakebi P, Keller C, Benzer A. Effect of total intravenous anaesthesia and balanced anaesthesia on the frequency of coughing during emergence from the anaesthesia. Br J Anaesth. 2007 Oct;99(4):587-91. doi: 10.1093/bja/aem203. Epub 2007 Jul 27.
- Background: PubMed 23344124von Ungern-Sternberg BS, Davies K, Hegarty M, Erb TO, Habre W. The effect of deep vs. awake extubation on respiratory complications in high-risk children undergoing adenotonsillectomy: a randomised controlled trial. Eur J Anaesthesiol. 2013 Sep;30(9):529-36. doi: 10.1097/EJA.0b013e32835df608.
- Derived from this study: PubMed 39618204Liao R, Zhou Z, Wang X, Shao H. Impact of Propofol Administered before Extubation on Respiratory Adverse Events in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Randomized Controlled Trial. Br J Hosp Med (Lond). 2024 Nov 30;85(11):1-15. doi: 10.12968/hmed.2024.0431. Epub 2024 Nov 18.
- Individual participant dataSharing planned: No
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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.
Zhijian Zhou study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propofol and normal saline in people with Airway Complication of Anesthesia, run by Children's Hospital of Fudan University at 1 site in China.
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 4 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 5 Feb 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 China. 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?
respiratory adverse events (time frame: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.). 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 NCT05769842, which also lists 4 linked publications.
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 5 Feb 2024.